Trial Outcomes & Findings for Alternative Dosing of Exemestane Before Surgery in Treating Postmenopausal Patients With Stage 0-II Estrogen Positive Breast Cancer (NCT NCT02598557)
NCT ID: NCT02598557
Last Updated: 2023-08-22
Results Overview
LS means of percent change
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
180 participants
Primary outcome timeframe
baseline and 4-6 weeks
Results posted on
2023-08-22
Participant Flow
50 participants were not randomized (25 not eligible, 20 withdrew consent, 5 other reasons)
Participant milestones
| Measure |
Exemestane 25 mg QD
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
59
|
58
|
63
|
|
Overall Study
COMPLETED
|
55
|
56
|
60
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
3
|
Reasons for withdrawal
| Measure |
Exemestane 25 mg QD
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Participant did not start treatment
|
2
|
1
|
1
|
|
Overall Study
Unavailable specimen for endpoint evaluations
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
Baseline Characteristics
The numbers are lower because there were no specimen available for analysis.
Baseline characteristics by cohort
| Measure |
Exemestane 25 mg QD
n=57 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=57 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=62 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Circulating levels of leptin
|
35.1 ng/mL
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
41.7 ng/mL
n=56 Participants • The numbers are lower because there were no specimen available for analysis.
|
38.5 ng/mL
n=60 Participants • The numbers are lower because there were no specimen available for analysis.
|
36.6 ng/mL
n=171 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Tissue biopsy estrogen receptor level (centralized evaluation)
|
99 Percentage of positive tumor cells
n=52 Participants • The numbers are lower because there were no specimen available for analysis.
|
99 Percentage of positive tumor cells
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
99 Percentage of positive tumor cells
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
99 Percentage of positive tumor cells
n=160 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Age, Categorical
<=18 years
|
0 Participants
n=57 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=176 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=57 Participants
|
32 Participants
n=57 Participants
|
29 Participants
n=62 Participants
|
86 Participants
n=176 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=57 Participants
|
25 Participants
n=57 Participants
|
33 Participants
n=62 Participants
|
90 Participants
n=176 Participants
|
|
Age, Continuous
|
66 years
n=57 Participants
|
63 years
n=57 Participants
|
65 years
n=62 Participants
|
64 years
n=176 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=57 Participants
|
57 Participants
n=57 Participants
|
62 Participants
n=62 Participants
|
176 Participants
n=176 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=57 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=176 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=57 Participants
|
7 Participants
n=57 Participants
|
10 Participants
n=62 Participants
|
20 Participants
n=176 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=57 Participants
|
49 Participants
n=57 Participants
|
51 Participants
n=62 Participants
|
152 Participants
n=176 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=57 Participants
|
1 Participants
n=57 Participants
|
1 Participants
n=62 Participants
|
4 Participants
n=176 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=57 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=176 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=57 Participants
|
1 Participants
n=57 Participants
|
2 Participants
n=62 Participants
|
6 Participants
n=176 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=57 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=176 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=57 Participants
|
2 Participants
n=57 Participants
|
3 Participants
n=62 Participants
|
8 Participants
n=176 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=57 Participants
|
51 Participants
n=57 Participants
|
55 Participants
n=62 Participants
|
155 Participants
n=176 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=57 Participants
|
0 Participants
n=57 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=176 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=57 Participants
|
3 Participants
n=57 Participants
|
1 Participants
n=62 Participants
|
5 Participants
n=176 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=57 Participants
|
31 participants
n=57 Participants
|
34 participants
n=62 Participants
|
93 participants
n=176 Participants
|
|
Region of Enrollment
Italy
|
29 participants
n=57 Participants
|
26 participants
n=57 Participants
|
28 participants
n=62 Participants
|
83 participants
n=176 Participants
|
|
Circulating levels of unconjugated estradiol SPE (Solid phase extraction)
|
21.6 pmol/L
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
22.4 pmol/L
n=56 Participants • The numbers are lower because there were no specimen available for analysis.
|
20.6 pmol/L
n=60 Participants • The numbers are lower because there were no specimen available for analysis.
|
21.3 pmol/L
n=171 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Circulating levels of unconjugated estradiol LLE (Liquid liquid extraction)
|
21.2 pmol/L
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
20.9 pmol/L
n=56 Participants • The numbers are lower because there were no specimen available for analysis.
|
19.7 pmol/L
n=60 Participants • The numbers are lower because there were no specimen available for analysis.
|
20.5 pmol/L
n=171 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Circulating levels of unconjugated estrone SPE(Solid phase extraction)
|
104.3 pmol/L
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
99.4 pmol/L
n=56 Participants • The numbers are lower because there were no specimen available for analysis.
|
92.2 pmol/L
n=60 Participants • The numbers are lower because there were no specimen available for analysis.
|
98.7 pmol/L
n=171 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Circulating levels of unconjugated estrone LLE (Liquid liquid extraction)
|
101.0 pmol/L
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
96.2 pmol/L
n=56 Participants • The numbers are lower because there were no specimen available for analysis.
|
93.4 pmol/L
n=60 Participants • The numbers are lower because there were no specimen available for analysis.
|
98.3 pmol/L
n=171 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Circulating levels of total estrone
|
294.7 pmol/L
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
302.2 pmol/L
n=56 Participants • The numbers are lower because there were no specimen available for analysis.
|
246.1 pmol/L
n=60 Participants • The numbers are lower because there were no specimen available for analysis.
|
279.9 pmol/L
n=171 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Circulating levels of estrone sulfate
|
581.9 pmol/L
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
625.8 pmol/L
n=56 Participants • The numbers are lower because there were no specimen available for analysis.
|
452.3 pmol/L
n=60 Participants • The numbers are lower because there were no specimen available for analysis.
|
560.4 pmol/L
n=171 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Circulating levels of androstenedione
|
1.5 nmol/L
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
1.7 nmol/L
n=56 Participants • The numbers are lower because there were no specimen available for analysis.
|
1.4 nmol/L
n=60 Participants • The numbers are lower because there were no specimen available for analysis.
|
1.5 nmol/L
n=171 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Circulating levels of testosterone
|
0.6 nmol/L
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
0.7 nmol/L
n=56 Participants • The numbers are lower because there were no specimen available for analysis.
|
0.6 nmol/L
n=60 Participants • The numbers are lower because there were no specimen available for analysis.
|
0.6 nmol/L
n=171 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Circulating levels of testosterone CLIA (Chemiluminescent immunoassay)
|
0.447 nmol/L
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
0.512 nmol/L
n=56 Participants • The numbers are lower because there were no specimen available for analysis.
|
0.425 nmol/L
n=60 Participants • The numbers are lower because there were no specimen available for analysis.
|
0.477 nmol/L
n=171 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Circulating levels of SHBG (Sex Hormone-Binding Globulin)
|
53.4 nmol/L
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
47.9 nmol/L
n=56 Participants • The numbers are lower because there were no specimen available for analysis.
|
50.1 nmol/L
n=60 Participants • The numbers are lower because there were no specimen available for analysis.
|
50.6 nmol/L
n=171 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Circulating levels of total cholesterol
|
205 mg/dL
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
208 mg/dL
n=56 Participants • The numbers are lower because there were no specimen available for analysis.
|
220 mg/dL
n=60 Participants • The numbers are lower because there were no specimen available for analysis.
|
213 mg/dL
n=171 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Circulating levels of High density lipoprotein (HDL) cholesterol
|
62 mg/dL
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
59 mg/dL
n=56 Participants • The numbers are lower because there were no specimen available for analysis.
|
57 mg/dL
n=60 Participants • The numbers are lower because there were no specimen available for analysis.
|
59 mg/dL
n=171 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Circulating levels of Low density lipoprotein (LDL) cholesterol
|
122.7 mg/dL
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
120.4 mg/dL
n=56 Participants • The numbers are lower because there were no specimen available for analysis.
|
132.3 mg/dL
n=60 Participants • The numbers are lower because there were no specimen available for analysis.
|
123.6 mg/dL
n=171 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Circulating levels of triglycerides
|
104 mg/dL
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
92 mg/dL
n=56 Participants • The numbers are lower because there were no specimen available for analysis.
|
119 mg/dL
n=60 Participants • The numbers are lower because there were no specimen available for analysis.
|
108 mg/dL
n=171 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Circulating levels of insulin
|
7.6 uU/mL
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
8.1 uU/mL
n=56 Participants • The numbers are lower because there were no specimen available for analysis.
|
7.9 uU/mL
n=60 Participants • The numbers are lower because there were no specimen available for analysis.
|
8.0 uU/mL
n=171 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Baseline levels of serum glucose
|
96 mg/dL
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
98 mg/dL
n=56 Participants • The numbers are lower because there were no specimen available for analysis.
|
95 mg/dL
n=60 Participants • The numbers are lower because there were no specimen available for analysis.
|
97 mg/dL
n=171 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
HOMA IR
|
1.76 HOMA IR Index
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
1.99 HOMA IR Index
n=56 Participants • The numbers are lower because there were no specimen available for analysis.
|
1.96 HOMA IR Index
n=60 Participants • The numbers are lower because there were no specimen available for analysis.
|
1.94 HOMA IR Index
n=171 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Circulating levels of adiponectin
|
10.99 µg/mL
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
8.82 µg/mL
n=56 Participants • The numbers are lower because there were no specimen available for analysis.
|
8.99 µg/mL
n=60 Participants • The numbers are lower because there were no specimen available for analysis.
|
9.5 µg/mL
n=171 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Tissue biopsy progesteron receptor level (centralized evaluation)
|
65 Percentage of positive tumor cells
n=52 Participants • The numbers are lower because there were no specimen available for analysis.
|
70 Percentage of positive tumor cells
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
70 Percentage of positive tumor cells
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
70 Percentage of positive tumor cells
n=160 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Tissue biopsy Ki-67 cancer tissue (centralized evaluation)
|
13 Percentage of positive tumor cells
n=52 Participants • The numbers are lower because there were no specimen available for analysis.
|
13 Percentage of positive tumor cells
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
12 Percentage of positive tumor cells
n=55 Participants • The numbers are lower because there were no specimen available for analysis.
|
12 Percentage of positive tumor cells
n=160 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Tissue biopsy Ki-67 adjacent non cancer tissue (centralized evaluation)
|
1 Percentage of positive tumor cells
n=28 Participants • The numbers are lower because there were no specimen available for analysis.
|
1 Percentage of positive tumor cells
n=22 Participants • The numbers are lower because there were no specimen available for analysis.
|
1 Percentage of positive tumor cells
n=27 Participants • The numbers are lower because there were no specimen available for analysis.
|
1 Percentage of positive tumor cells
n=77 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
UGT2B17 Copy number variation distribution by arm
2
|
22 count
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
23 count
n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
19 count
n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
64 count
n=164 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
UGT2B17 Copy number variation distribution by arm
1
|
22 count
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
26 count
n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
30 count
n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
78 count
n=164 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
UGT2B17 Copy number variation distribution by arm
0
|
9 count
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
5 count
n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
8 count
n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
22 count
n=164 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
CYP19A1 rs10046 distribution by arm
wt/wt
|
11 Participants
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
15 Participants
n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
12 Participants
n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
38 Participants
n=164 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
CYP19A1 rs10046 distribution by arm
wt/v
|
31 Participants
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
31 Participants
n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
33 Participants
n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
95 Participants
n=164 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
CYP19A1 rs10046 distribution by arm
v/v
|
11 Participants
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
8 Participants
n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
12 Participants
n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
31 Participants
n=164 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
CYP19A1 rs4646 distribution by arm
wt/wt
|
29 Participants
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
25 Participants
n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
35 Participants
n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
89 Participants
n=164 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
CYP19A1 rs4646 distribution by arm
wt/v
|
18 Participants
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
25 Participants
n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
17 Participants
n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
60 Participants
n=164 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
CYP19A1 rs4646 distribution by arm
v/v
|
6 Participants
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
4 Participants
n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
5 Participants
n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
15 Participants
n=164 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
CYP3A4*22 rs35599367 distribution by arm
wt/wt
|
49 Participants
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
51 Participants
n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
56 Participants
n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
156 Participants
n=164 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
CYP3A4*22 rs35599367 distribution by arm
wt/v
|
4 Participants
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
3 Participants
n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
1 Participants
n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
8 Participants
n=164 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
CYP3A4*22 rs35599367 distribution by arm
v/v
|
0 Participants
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
0 Participants
n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
0 Participants
n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
0 Participants
n=164 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
SLCO1B1 rs4149056 distribution by arm
wt/wt
|
37 Participants
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
38 Participants
n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
41 Participants
n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
116 Participants
n=164 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
SLCO1B1 rs4149056 distribution by arm
wt/v
|
13 Participants
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
13 Participants
n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
16 Participants
n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
42 Participants
n=164 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
SLCO1B1 rs4149056 distribution by arm
v/v
|
3 Participants
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
3 Participants
n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
0 Participants
n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
6 Participants
n=164 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
SLCO1B1 rs10841753 distribution by arm
wt/wt
|
38 Participants
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
36 Participants
n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
38 Participants
n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
112 Participants
n=164 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
SLCO1B1 rs10841753 distribution by arm
wt/v
|
13 Participants
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
16 Participants
n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
17 Participants
n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
46 Participants
n=164 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
SLCO1B1 rs10841753 distribution by arm
v/v
|
2 Participants
n=53 Participants • The numbers are lower because there were no specimen available for analysis.
|
2 Participants
n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
2 Participants
n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
6 Participants
n=164 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Menopause specific quality of life questionnaire mean score
Vasomotor domain
|
2.2 score on a scale
STANDARD_DEVIATION 1.9 • n=48 Participants • The numbers are lower because there were no specimen available for analysis.
|
2.5 score on a scale
STANDARD_DEVIATION 1.9 • n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
2.6 score on a scale
STANDARD_DEVIATION 1.9 • n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
2.4 score on a scale
STANDARD_DEVIATION 1.8 • n=159 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Menopause specific quality of life questionnaire mean score
Psychosocial domain
|
2.5 score on a scale
STANDARD_DEVIATION 1.3 • n=48 Participants • The numbers are lower because there were no specimen available for analysis.
|
2.3 score on a scale
STANDARD_DEVIATION 1.2 • n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
2.6 score on a scale
STANDARD_DEVIATION 1.5 • n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
2.5 score on a scale
STANDARD_DEVIATION 1.4 • n=159 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Menopause specific quality of life questionnaire mean score
Physical domain
|
2.5 score on a scale
STANDARD_DEVIATION 1.1 • n=48 Participants • The numbers are lower because there were no specimen available for analysis.
|
2.3 score on a scale
STANDARD_DEVIATION 0.9 • n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
2.6 score on a scale
STANDARD_DEVIATION 1.4 • n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
2.5 score on a scale
STANDARD_DEVIATION 1.2 • n=159 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Menopause specific quality of life questionnaire mean score
Sexual domain
|
2.0 score on a scale
STANDARD_DEVIATION 1.4 • n=48 Participants • The numbers are lower because there were no specimen available for analysis.
|
1.9 score on a scale
STANDARD_DEVIATION 1.9 • n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
2.2 score on a scale
STANDARD_DEVIATION 1.8 • n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
2.1 score on a scale
STANDARD_DEVIATION 1.6 • n=159 Participants • The numbers are lower because there were no specimen available for analysis.
|
|
Menopause specific quality of life questionnaire mean score
Overall
|
2.3 score on a scale
STANDARD_DEVIATION 0.9 • n=48 Participants • The numbers are lower because there were no specimen available for analysis.
|
2.2 score on a scale
STANDARD_DEVIATION 1.0 • n=54 Participants • The numbers are lower because there were no specimen available for analysis.
|
2.5 score on a scale
STANDARD_DEVIATION 1.1 • n=57 Participants • The numbers are lower because there were no specimen available for analysis.
|
2.4 score on a scale
STANDARD_DEVIATION 1.0 • n=159 Participants • The numbers are lower because there were no specimen available for analysis.
|
PRIMARY outcome
Timeframe: baseline and 4-6 weeksLS means of percent change
Outcome measures
| Measure |
Exemestane 25 mg QD
n=55 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=56 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=60 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Percent Change in Time of Circulating Estradiol SPE in Each Arm
|
-89 percent change
Interval -95.0 to -83.0
|
-85 percent change
Interval -98.0 to -73.0
|
-60 percent change
Interval -78.0 to -42.0
|
SECONDARY outcome
Timeframe: baseline and 4-6 weeksLS means of percent change
Outcome measures
| Measure |
Exemestane 25 mg QD
n=55 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=56 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=60 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Percent Change in Time of Circulating Estradiol LLE in Each Arm
|
-96 percent change
Interval -97.0 to -95.0
|
-91 percent change
Interval -95.0 to -88.0
|
-72 percent change
Interval -77.0 to -67.0
|
SECONDARY outcome
Timeframe: baseline and 4-6 weeks\[(Final levels-baseline levels)/baseline levels\]\*100
Outcome measures
| Measure |
Exemestane 25 mg QD
n=53 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=56 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=59 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Percent Change of Circulating Estrone SPE
|
-93 percent change
Interval -98.0 to -88.0
|
-89 percent change
Interval -96.0 to -83.0
|
-73 percent change
Interval -81.0 to -52.0
|
SECONDARY outcome
Timeframe: baseline and 4-6 weeks\[(Final levels-baseline levels)/baseline levels\]\*100
Outcome measures
| Measure |
Exemestane 25 mg QD
n=55 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=56 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=60 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Percent Change of Circulating Estrone LLE
|
-99 percent change
Interval -99.0 to -98.0
|
-96 percent change
Interval -97.0 to -93.0
|
-78 percent change
Interval -85.0 to -62.0
|
SECONDARY outcome
Timeframe: baseline and 4-6 weeks\[(Final levels-baseline levels)/baseline levels\]\*100
Outcome measures
| Measure |
Exemestane 25 mg QD
n=55 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=56 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=60 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Percent Change of Circulating Total Estrone
|
-95 percent change
Interval -97.0 to -91.0
|
-94 percent change
Interval -96.0 to -90.0
|
-76 percent change
Interval -85.0 to -63.0
|
SECONDARY outcome
Timeframe: baseline and 4-6 weeks\[(Final levels-baseline levels)/baseline levels\]\*100
Outcome measures
| Measure |
Exemestane 25 mg QD
n=55 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=56 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=60 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Percent Change of Circulating Estrone Sulfate
|
-96 percent change
Interval -98.0 to -94.0
|
-95 percent change
Interval -97.0 to -92.0
|
-75 percent change
Interval -83.0 to -64.0
|
SECONDARY outcome
Timeframe: baseline and 4-6 weeks\[(Final levels-baseline levels)/baseline levels\]\*100
Outcome measures
| Measure |
Exemestane 25 mg QD
n=55 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=56 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=59 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Percent Change of Circulating Androstenedione
|
0 percent change
Interval -18.0 to 18.0
|
11 percent change
Interval -20.0 to 30.0
|
11 percent change
Interval -14.0 to 43.0
|
SECONDARY outcome
Timeframe: baseline and 4-6 weeks\[(Final levels-baseline levels)/baseline levels\]\*100
Outcome measures
| Measure |
Exemestane 25 mg QD
n=55 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=56 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=59 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Percent Change of Circulating Testosterone
|
-19 percent change
Interval -33.0 to 0.0
|
0 percent change
Interval -25.0 to 0.0
|
0 percent change
Interval -20.0 to 18.0
|
SECONDARY outcome
Timeframe: baseline and 4-6 weeks\[(Final levels-baseline levels)/baseline levels\]\*100
Outcome measures
| Measure |
Exemestane 25 mg QD
n=53 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=56 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=60 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Percent Change of Circulating Testosterone CLIA
|
10 percent change
Interval -12.0 to 46.0
|
0 percent change
Interval -26.0 to 29.0
|
6 percent change
Interval -18.0 to 53.0
|
SECONDARY outcome
Timeframe: baseline and 4-6 weeks\[(Final levels-baseline levels)/baseline levels\]\*100
Outcome measures
| Measure |
Exemestane 25 mg QD
n=55 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=56 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=60 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Percent Change of Circulating SHBG
|
-29 percent change
Interval -36.0 to -17.0
|
-15 percent change
Interval -23.0 to -7.0
|
-5.5 percent change
Interval -17.0 to 1.2
|
SECONDARY outcome
Timeframe: baseline and 4-6 weeks\[(Final levels-baseline levels)/baseline levels\]\*100
Outcome measures
| Measure |
Exemestane 25 mg QD
n=54 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=55 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=58 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Percent Change of Circulating Total Cholesterol
|
-4 percent change
Interval -17.0 to 4.0
|
-5 percent change
Interval -9.0 to 5.0
|
-1 percent change
Interval -9.0 to 6.0
|
SECONDARY outcome
Timeframe: baseline and 4-6 weeks\[(Final levels-baseline levels)/baseline levels\]\*100
Outcome measures
| Measure |
Exemestane 25 mg QD
n=54 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=56 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=58 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Percent Change of Circulating HDL Cholesterol
|
-14 percent change
Interval -21.0 to -3.0
|
-3 percent change
Interval -13.0 to 4.0
|
-2 percent change
Interval -10.0 to 4.0
|
SECONDARY outcome
Timeframe: baseline and 4-6 weeks\[(Final levels-baseline levels)/baseline levels\]\*100
Outcome measures
| Measure |
Exemestane 25 mg QD
n=54 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=55 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=58 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Percent Change of Circulating LDL Cholesterol
|
-1 percent change
Interval -18.0 to 13.0
|
0 percent change
Interval -13.0 to 10.0
|
0 percent change
Interval -13.0 to 9.0
|
SECONDARY outcome
Timeframe: baseline and 4-6 weeks\[(Final levels-baseline levels)/baseline levels\]\*100
Outcome measures
| Measure |
Exemestane 25 mg QD
n=54 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=55 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=58 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Percent Change of Circulating Triglycerides
|
-7 percent change
Interval -22.0 to 25.0
|
-1 percent change
Interval -19.0 to 17.0
|
5 percent change
Interval -17.0 to 23.0
|
SECONDARY outcome
Timeframe: baseline and 4-6 weeks\[(Final levels-baseline levels)/baseline levels\]\*100
Outcome measures
| Measure |
Exemestane 25 mg QD
n=55 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=56 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=60 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Percent Change of Circulating Insulin
|
3 percent change
Interval -15.0 to 46.0
|
9 percent change
Interval -19.0 to 47.0
|
4 percent change
Interval -22.0 to 33.0
|
SECONDARY outcome
Timeframe: baseline and 4-6 weeks\[(Final levels-baseline levels)/baseline levels\]\*100
Outcome measures
| Measure |
Exemestane 25 mg QD
n=55 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=56 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=60 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Percent Change of Serum Glucose
|
-1 percent change
Interval -7.0 to 9.0
|
1 percent change
Interval -9.0 to 9.0
|
-2 percent change
Interval -5.0 to 6.0
|
SECONDARY outcome
Timeframe: baseline and 4-6 weeksInsulin Resistance Index (HOMA-IR) measures insulin resistance, calculated by fasting insulin (mU/L) multiplied by fasting glucose (mmol/L), and divided by a constant (22.5). A higher score indicates higher insulin resistance.
Outcome measures
| Measure |
Exemestane 25 mg QD
n=55 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=56 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=59 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Percent Change of HOMA IR
|
8 percent change
Interval -18.0 to 55.0
|
15 percent change
Interval -19.0 to 53.0
|
6 percent change
Interval -26.0 to 39.0
|
SECONDARY outcome
Timeframe: baseline and 4-6 weeks\[(Final levels-baseline levels)/baseline levels\]\*100
Outcome measures
| Measure |
Exemestane 25 mg QD
n=55 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=56 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=60 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Percent Change of Circulating Adiponectin
|
-12 percent change
Interval -19.0 to 4.0
|
-3 percent change
Interval -11.0 to 10.0
|
-1 percent change
Interval -9.0 to 6.0
|
SECONDARY outcome
Timeframe: baseline and 4-6 weeks\[(Final levels-baseline levels)/baseline levels\]\*100
Outcome measures
| Measure |
Exemestane 25 mg QD
n=55 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=56 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=60 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Percent Change of Circulating Leptin
|
-16 percent change
Interval -33.0 to -3.0
|
-5 percent change
Interval -22.0 to 8.0
|
-4 percent change
Interval -17.0 to 20.0
|
SECONDARY outcome
Timeframe: at surgeryFinal drug concentration
Outcome measures
| Measure |
Exemestane 25 mg QD
n=54 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=55 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=58 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Exemestane Blood Concentration at Surgery
|
3217 pmol/L
Interval 2320.0 to 4567.0
|
513 pmol/L
Interval 341.0 to 727.0
|
24 pmol/L
Interval 17.0 to 46.0
|
SECONDARY outcome
Timeframe: at surgeryFinal drug concentration
Outcome measures
| Measure |
Exemestane 25 mg QD
n=54 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=55 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=58 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
17-OH Exemestane Blood Concentration at Surgery
|
1069 pmol/L
Interval 644.0 to 1657.0
|
196 pmol/L
Interval 119.0 to 363.0
|
4 pmol/L
Interval 4.0 to 22.0
|
SECONDARY outcome
Timeframe: 4-6 weeksSurgery level-biopsy level.
Outcome measures
| Measure |
Exemestane 25 mg QD
n=50 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=53 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=55 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Change of ER Expression (Cancer Tissue), Central Review
|
0 Abs change of % of positive tumor cells
Interval 0.0 to 0.0
|
0 Abs change of % of positive tumor cells
Interval -4.0 to 4.0
|
0 Abs change of % of positive tumor cells
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 4-6 weeksSurgery level-biopsy level.
Outcome measures
| Measure |
Exemestane 25 mg QD
n=52 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=53 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=55 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Change of PgR Expression (Cancer Tissue), Central Review
|
-17 Abs change of % of positive tumor cells
Interval -67.0 to -4.0
|
-9 Abs change of % of positive tumor cells
Interval -50.0 to 0.0
|
-7 Abs change of % of positive tumor cells
Interval -25.0 to 0.0
|
SECONDARY outcome
Timeframe: 4-6 weeksSurgery level-biopsy level.
Outcome measures
| Measure |
Exemestane 25 mg QD
n=52 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=53 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=55 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Change of Ki67% Expression (Cancer Tissue), Central Review
|
-7.5 Abs change of % of positive tumor cells
Interval -11.0 to -3.0
|
-5 Abs change of % of positive tumor cells
Interval -10.0 to -1.0
|
-4 Abs change of % of positive tumor cells
Interval -8.0 to -1.0
|
SECONDARY outcome
Timeframe: 4-6 weeksSurgery level-biopsy level.
Outcome measures
| Measure |
Exemestane 25 mg QD
n=28 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=22 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=27 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Change of Ki67% Expression (Adjacent Non Cancer Tissue), Central Review
|
0 Absolute change of % of positive cells
Interval 0.0 to 1.0
|
0 Absolute change of % of positive cells
Interval -0.5 to 0.5
|
0 Absolute change of % of positive cells
Interval -1.0 to 1.0
|
SECONDARY outcome
Timeframe: 4-6 weeksFinal biomarker concentration
Outcome measures
| Measure |
Exemestane 25 mg QD
n=43 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=37 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=40 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Estradiol Tissue Concentration at Surgery
cancer tissue
|
15.5 fmol/g wet weight
Interval 15.5 to 52.2
|
17.1 fmol/g wet weight
Interval 15.5 to 125.3
|
128.8 fmol/g wet weight
Interval 15.5 to 224.8
|
|
Estradiol Tissue Concentration at Surgery
non cancer adjacent tissue
|
15.5 fmol/g wet weight
Interval 15.5 to 15.5
|
15.5 fmol/g wet weight
Interval 15.5 to 15.5
|
15.5 fmol/g wet weight
Interval 15.5 to 25.5
|
SECONDARY outcome
Timeframe: 4-6 weeksFinal biomarker concentration
Outcome measures
| Measure |
Exemestane 25 mg QD
n=43 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=37 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=40 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Estrone Tissue Concentration at Surgery
cancer tissue
|
8.7 fmol/g wet weight
Interval 4.5 to 21.7
|
28.1 fmol/g wet weight
Interval 17.8 to 41.6
|
138.9 fmol/g wet weight
Interval 53.2 to 246.7
|
|
Estrone Tissue Concentration at Surgery
non cancer adjacent tissue
|
17.4 fmol/g wet weight
Interval 4.8 to 33.0
|
37.8 fmol/g wet weight
Interval 21.7 to 67.5
|
140.5 fmol/g wet weight
Interval 68.2 to 233.3
|
SECONDARY outcome
Timeframe: 4-6 weeksFinal biomarker concentration.
Outcome measures
| Measure |
Exemestane 25 mg QD
n=43 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=37 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=40 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Androstenedione Tissue Concentration at Surgery
cancer tissue
|
6864 fmol/g wet weight
Interval 3324.0 to 8890.0
|
5314 fmol/g wet weight
Interval 3692.0 to 6642.0
|
5564 fmol/g wet weight
Interval 3194.0 to 8116.0
|
|
Androstenedione Tissue Concentration at Surgery
non cancer adjacent tissue
|
10251 fmol/g wet weight
Interval 6541.0 to 16103.0
|
12366 fmol/g wet weight
Interval 8702.0 to 18654.0
|
10580 fmol/g wet weight
Interval 5403.0 to 15003.0
|
SECONDARY outcome
Timeframe: 4-6 weeksFinal biomarker concentration
Outcome measures
| Measure |
Exemestane 25 mg QD
n=43 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=37 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=40 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Testosterone Tissue Concentration at Surgery
cancer tissue
|
395 fmol/g wet weight
Interval 273.0 to 567.0
|
396 fmol/g wet weight
Interval 346.0 to 790.0
|
453 fmol/g wet weight
Interval 314.0 to 700.0
|
|
Testosterone Tissue Concentration at Surgery
non cancer adjacent tissue
|
436 fmol/g wet weight
Interval 273.0 to 654.0
|
464 fmol/g wet weight
Interval 341.0 to 787.0
|
399 fmol/g wet weight
Interval 299.0 to 570.0
|
SECONDARY outcome
Timeframe: 4-6 weeksFinal drug concentration
Outcome measures
| Measure |
Exemestane 25 mg QD
n=43 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=37 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=40 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Exemestane Tissue Concentration at Surgery
cancer tissue
|
3807 fmol/g wet weight
Interval 1663.0 to 7194.0
|
44 fmol/g wet weight
Interval 44.0 to 291.0
|
44 fmol/g wet weight
Interval 44.0 to 44.0
|
|
Exemestane Tissue Concentration at Surgery
non cancer adjacent tissue
|
17485 fmol/g wet weight
Interval 6791.0 to 31985.0
|
435 fmol/g wet weight
Interval 44.0 to 791.0
|
44 fmol/g wet weight
Interval 44.0 to 44.0
|
SECONDARY outcome
Timeframe: 4-6 weeksFinal drug concentration
Outcome measures
| Measure |
Exemestane 25 mg QD
n=43 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=37 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=40 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
17 OH Exemestane Tissue Concentration at Surgery
cancer tissue
|
338 fmol/g wet weight
Interval 64.0 to 1360.0
|
65 fmol/g wet weight
Interval 65.0 to 65.0
|
65 fmol/g wet weight
Interval 65.0 to 65.0
|
|
17 OH Exemestane Tissue Concentration at Surgery
non cancer adjacent tissue
|
1343 fmol/g wet weight
Interval 262.0 to 2758.0
|
65 fmol/g wet weight
Interval 65.0 to 65.0
|
65 fmol/g wet weight
Interval 65.0 to 65.0
|
SECONDARY outcome
Timeframe: baseline and 4-6 weeksMenQOL questionnaire assessed how bothered participants were with 31 symptoms. It contains domains: vasomotor (items 1-3); psychosocial (items 4-10); physical (items 11-26); sexual (items 27-29); in addition to nausea and indigestion. 31 individual symptoms are rated on a scale of 0 (not at all bothered) to 6 (extremely bothered). Total possible score ranged from 0 to 186. MenQOL summary score was calculated as mean of four domain scores (Physical function, Psychosocial function, Sexual function and Vasomotor function) ranging from 1 to 8, with higher scores indicating worse quality of life. Final score-baseline score
Outcome measures
| Measure |
Exemestane 25 mg QD
n=47 Participants
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=53 Participants
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=56 Participants
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Change in MenQoL Questionnaire Score
Vasomotor domain
|
0.41 score on a scale
Standard Deviation 1.2
|
0.28 score on a scale
Standard Deviation 1.4
|
0.51 score on a scale
Standard Deviation 1.5
|
|
Change in MenQoL Questionnaire Score
Psychosocial domain
|
-0.19 score on a scale
Standard Deviation 0.98
|
0.06 score on a scale
Standard Deviation 1.2
|
-0.06 score on a scale
Standard Deviation 1.1
|
|
Change in MenQoL Questionnaire Score
Physical domain
|
-0.37 score on a scale
Standard Deviation 0.77
|
0.07 score on a scale
Standard Deviation 0.86
|
-0.09 score on a scale
Standard Deviation 0.67
|
|
Change in MenQoL Questionnaire Score
Sexual domain
|
-0.45 score on a scale
Standard Deviation 1.0
|
-0.2 score on a scale
Standard Deviation 1.7
|
-0.52 score on a scale
Standard Deviation 1.7
|
|
Change in MenQoL Questionnaire Score
Overall
|
-0.15 score on a scale
Standard Deviation 0.58
|
0.05 score on a scale
Standard Deviation 0.79
|
-0.06 score on a scale
Standard Deviation 0.71
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4-6 weeksThe Proteomic Analysis was not performed.
Outcome measures
Outcome data not reported
Adverse Events
Exemestane 25 mg QD
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Exemestane 25 mg TIW
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Exemestane 25 mg QW
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exemestane 25 mg QD
n=57 participants at risk
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=57 participants at risk
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=62 participants at risk
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Infections and infestations
Bone Infection
|
1.8%
1/57 • From the first dose of exemestane through 30 days after the surgery
|
0.00%
0/57 • From the first dose of exemestane through 30 days after the surgery
|
0.00%
0/62 • From the first dose of exemestane through 30 days after the surgery
|
Other adverse events
| Measure |
Exemestane 25 mg QD
n=57 participants at risk
1 tablet of exemestane 25 mg a day for up to 6 weeks
|
Exemestane 25 mg TIW
n=57 participants at risk
1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks
|
Exemestane 25 mg QW
n=62 participants at risk
1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
3.5%
2/57 • Number of events 2 • From the first dose of exemestane through 30 days after the surgery
|
5.3%
3/57 • Number of events 4 • From the first dose of exemestane through 30 days after the surgery
|
3.2%
2/62 • Number of events 2 • From the first dose of exemestane through 30 days after the surgery
|
|
Gastrointestinal disorders
Nausea
|
14.0%
8/57 • Number of events 8 • From the first dose of exemestane through 30 days after the surgery
|
19.3%
11/57 • Number of events 14 • From the first dose of exemestane through 30 days after the surgery
|
1.6%
1/62 • Number of events 1 • From the first dose of exemestane through 30 days after the surgery
|
|
General disorders
Fatigue
|
5.3%
3/57 • Number of events 4 • From the first dose of exemestane through 30 days after the surgery
|
12.3%
7/57 • Number of events 9 • From the first dose of exemestane through 30 days after the surgery
|
4.8%
3/62 • Number of events 3 • From the first dose of exemestane through 30 days after the surgery
|
|
General disorders
Irritability
|
1.8%
1/57 • Number of events 1 • From the first dose of exemestane through 30 days after the surgery
|
8.8%
5/57 • Number of events 5 • From the first dose of exemestane through 30 days after the surgery
|
0.00%
0/62 • From the first dose of exemestane through 30 days after the surgery
|
|
Infections and infestations
Upper respiratory infection
|
5.3%
3/57 • Number of events 3 • From the first dose of exemestane through 30 days after the surgery
|
0.00%
0/57 • From the first dose of exemestane through 30 days after the surgery
|
1.6%
1/62 • Number of events 1 • From the first dose of exemestane through 30 days after the surgery
|
|
Infections and infestations
Urinary tract infection
|
1.8%
1/57 • Number of events 1 • From the first dose of exemestane through 30 days after the surgery
|
5.3%
3/57 • Number of events 3 • From the first dose of exemestane through 30 days after the surgery
|
0.00%
0/62 • From the first dose of exemestane through 30 days after the surgery
|
|
Investigations
Alanine aminotransferase increased
|
7.0%
4/57 • Number of events 4 • From the first dose of exemestane through 30 days after the surgery
|
1.8%
1/57 • Number of events 1 • From the first dose of exemestane through 30 days after the surgery
|
3.2%
2/62 • Number of events 2 • From the first dose of exemestane through 30 days after the surgery
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
3/57 • Number of events 3 • From the first dose of exemestane through 30 days after the surgery
|
1.8%
1/57 • Number of events 1 • From the first dose of exemestane through 30 days after the surgery
|
3.2%
2/62 • Number of events 2 • From the first dose of exemestane through 30 days after the surgery
|
|
Investigations
GGT increased
|
5.3%
3/57 • Number of events 3 • From the first dose of exemestane through 30 days after the surgery
|
3.5%
2/57 • Number of events 3 • From the first dose of exemestane through 30 days after the surgery
|
0.00%
0/62 • From the first dose of exemestane through 30 days after the surgery
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.3%
7/57 • Number of events 7 • From the first dose of exemestane through 30 days after the surgery
|
12.3%
7/57 • Number of events 7 • From the first dose of exemestane through 30 days after the surgery
|
11.3%
7/62 • Number of events 8 • From the first dose of exemestane through 30 days after the surgery
|
|
Gastrointestinal disorders
Diarrhea
|
8.8%
5/57 • Number of events 6 • From the first dose of exemestane through 30 days after the surgery
|
1.8%
1/57 • Number of events 1 • From the first dose of exemestane through 30 days after the surgery
|
3.2%
2/62 • Number of events 2 • From the first dose of exemestane through 30 days after the surgery
|
|
Gastrointestinal disorders
Dry mouth
|
1.8%
1/57 • Number of events 1 • From the first dose of exemestane through 30 days after the surgery
|
5.3%
3/57 • Number of events 3 • From the first dose of exemestane through 30 days after the surgery
|
0.00%
0/62 • From the first dose of exemestane through 30 days after the surgery
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
1/57 • Number of events 1 • From the first dose of exemestane through 30 days after the surgery
|
3.5%
2/57 • Number of events 2 • From the first dose of exemestane through 30 days after the surgery
|
6.5%
4/62 • Number of events 4 • From the first dose of exemestane through 30 days after the surgery
|
|
Nervous system disorders
Dizziness
|
3.5%
2/57 • Number of events 3 • From the first dose of exemestane through 30 days after the surgery
|
5.3%
3/57 • Number of events 3 • From the first dose of exemestane through 30 days after the surgery
|
1.6%
1/62 • Number of events 1 • From the first dose of exemestane through 30 days after the surgery
|
|
Nervous system disorders
Headache
|
10.5%
6/57 • Number of events 8 • From the first dose of exemestane through 30 days after the surgery
|
14.0%
8/57 • Number of events 11 • From the first dose of exemestane through 30 days after the surgery
|
6.5%
4/62 • Number of events 6 • From the first dose of exemestane through 30 days after the surgery
|
|
Psychiatric disorders
Anxiety
|
5.3%
3/57 • Number of events 3 • From the first dose of exemestane through 30 days after the surgery
|
0.00%
0/57 • From the first dose of exemestane through 30 days after the surgery
|
4.8%
3/62 • Number of events 3 • From the first dose of exemestane through 30 days after the surgery
|
|
Psychiatric disorders
Insomnia
|
5.3%
3/57 • Number of events 3 • From the first dose of exemestane through 30 days after the surgery
|
10.5%
6/57 • Number of events 6 • From the first dose of exemestane through 30 days after the surgery
|
11.3%
7/62 • Number of events 7 • From the first dose of exemestane through 30 days after the surgery
|
|
Reproductive system and breast disorders
Breast pain
|
3.5%
2/57 • Number of events 2 • From the first dose of exemestane through 30 days after the surgery
|
1.8%
1/57 • Number of events 1 • From the first dose of exemestane through 30 days after the surgery
|
6.5%
4/62 • Number of events 4 • From the first dose of exemestane through 30 days after the surgery
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.0%
4/57 • Number of events 4 • From the first dose of exemestane through 30 days after the surgery
|
0.00%
0/57 • From the first dose of exemestane through 30 days after the surgery
|
0.00%
0/62 • From the first dose of exemestane through 30 days after the surgery
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/57 • From the first dose of exemestane through 30 days after the surgery
|
1.8%
1/57 • Number of events 1 • From the first dose of exemestane through 30 days after the surgery
|
6.5%
4/62 • Number of events 4 • From the first dose of exemestane through 30 days after the surgery
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.8%
1/57 • Number of events 1 • From the first dose of exemestane through 30 days after the surgery
|
8.8%
5/57 • Number of events 5 • From the first dose of exemestane through 30 days after the surgery
|
1.6%
1/62 • Number of events 1 • From the first dose of exemestane through 30 days after the surgery
|
|
Vascular disorders
Hot Flashes
|
21.1%
12/57 • Number of events 12 • From the first dose of exemestane through 30 days after the surgery
|
19.3%
11/57 • Number of events 12 • From the first dose of exemestane through 30 days after the surgery
|
25.8%
16/62 • Number of events 16 • From the first dose of exemestane through 30 days after the surgery
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/57 • From the first dose of exemestane through 30 days after the surgery
|
5.3%
3/57 • Number of events 3 • From the first dose of exemestane through 30 days after the surgery
|
0.00%
0/62 • From the first dose of exemestane through 30 days after the surgery
|
Additional Information
Parijatham S. Thomas, MD., Associate Professor, Clinical Cancer Prevention
UT MD Anderson Cancer Center
Phone: (713) 745-1075
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60