Trial Outcomes & Findings for Endocrine Response in Women With Invasive Lobular Breast Cancer (NCT NCT02206984)
NCT ID: NCT02206984
Last Updated: 2026-08-07
Results Overview
Ki67 expression is a routine pathologic marker that is strongly associated with cell proliferation. It is extensively used as a prognostic and predictive marker in cancer. Ki67 was calculated as a percentage of 1000 tumor cells counted in both the pre- and post-treatment specimens. The primary endpoint was change in log-transformed Ki67 at post-treatment compared to baseline. We used fixed paired differences with mean (SD) log (post/pre).
COMPLETED
PHASE2
201 participants
Baseline, Day 21-27
2026-08-07
Participant Flow
Participant milestones
| Measure |
Fulvestrant
500 mg, administered as two 250 mg IM injections, given on days 1 and 14
Fulvestrant
|
Anastrozole
1mg given orally daily for 21 days
Anastrozole
|
Tamoxifen
Tamoxifen is administered orally, at a dose of 20 mg,daily, for 21 days
Tamoxifen
|
|---|---|---|---|
|
Overall Study
STARTED
|
62
|
66
|
73
|
|
Overall Study
COMPLETED
|
62
|
66
|
73
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endocrine Response in Women With Invasive Lobular Breast Cancer
Baseline characteristics by cohort
| Measure |
Fulvestrant
n=62 Participants
500 mg, administered as two 250 mg IM injections, given on days 1 and 14
Fulvestrant
|
Anastrozole
n=66 Participants
1mg given orally daily for 21 days
Anastrozole
|
Tamoxifen
n=73 Participants
Tamoxifen is administered orally, at a dose of 20 mg,daily, for 21 days
Tamoxifen
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.77 years
STANDARD_DEVIATION 8.41 • n=20 Participants
|
65.82 years
STANDARD_DEVIATION 8.41 • n=20 Participants
|
66.92 years
STANDARD_DEVIATION 7.69 • n=40 Participants
|
66.82 years
STANDARD_DEVIATION 8.15 • n=6 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=20 Participants
|
66 Participants
n=20 Participants
|
73 Participants
n=40 Participants
|
201 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
11 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=20 Participants
|
57 Participants
n=20 Participants
|
67 Participants
n=40 Participants
|
179 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
11 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
24 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=20 Participants
|
56 Participants
n=20 Participants
|
61 Participants
n=40 Participants
|
169 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
5 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 21-27Population: Treated patients who provided samples for analysis.
Ki67 expression is a routine pathologic marker that is strongly associated with cell proliferation. It is extensively used as a prognostic and predictive marker in cancer. Ki67 was calculated as a percentage of 1000 tumor cells counted in both the pre- and post-treatment specimens. The primary endpoint was change in log-transformed Ki67 at post-treatment compared to baseline. We used fixed paired differences with mean (SD) log (post/pre).
Outcome measures
| Measure |
Fulvestrant
n=37 Participants
500 mg, administered as two 250 mg IM injections, given on days 1 and 14
Fulvestrant
|
Anastrozole
n=49 Participants
1mg given orally daily for 21 days
Anastrozole
|
Tamoxifen
n=52 Participants
Tamoxifen is administered orally, at a dose of 20 mg,daily, for 21 days
Tamoxifen
|
|---|---|---|---|
|
Change in Log-transformed Ki67 Proliferative Index
|
-1.22 Log-transformed Ki67 index ratio
Standard Deviation 1.1
|
-1.02 Log-transformed Ki67 index ratio
Standard Deviation 1.1
|
-0.72 Log-transformed Ki67 index ratio
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: BaselineKi67 expression is a routine pathologic marker that is strongly associated with cell proliferation. It is extensively used as a prognostic and predictive marker in cancer. Ki67 was calculated as a percentage of 1000 tumor cells counted in both the pre- and post-treatment specimens.
Outcome measures
| Measure |
Fulvestrant
n=37 Participants
500 mg, administered as two 250 mg IM injections, given on days 1 and 14
Fulvestrant
|
Anastrozole
n=49 Participants
1mg given orally daily for 21 days
Anastrozole
|
Tamoxifen
n=52 Participants
Tamoxifen is administered orally, at a dose of 20 mg,daily, for 21 days
Tamoxifen
|
|---|---|---|---|
|
Pre-treatment Ki67 Proliferative Index
|
13.8 percent
Interval 7.05 to 20.55
|
13.6 percent
Interval 9.25 to 17.95
|
12.6 percent
Interval 6.7 to 18.5
|
SECONDARY outcome
Timeframe: Day 21-27Ki67 expression is a routine pathologic marker that is strongly associated with cell proliferation. It is extensively used as a prognostic and predictive marker in cancer. Ki67 was calculated as a percentage of 1000 tumor cells counted in both the pre- and post-treatment specimens.
Outcome measures
| Measure |
Fulvestrant
n=37 Participants
500 mg, administered as two 250 mg IM injections, given on days 1 and 14
Fulvestrant
|
Anastrozole
n=49 Participants
1mg given orally daily for 21 days
Anastrozole
|
Tamoxifen
n=52 Participants
Tamoxifen is administered orally, at a dose of 20 mg,daily, for 21 days
Tamoxifen
|
|---|---|---|---|
|
Post-treatment Ki67 Proliferative Index
|
4.8 percent
Interval 2.1 to 7.5
|
4.5 percent
Interval 1.8 to 7.2
|
5.7 percent
Interval 0.7 to 10.7
|
SECONDARY outcome
Timeframe: BaselinePopulation: Treated patients who were evaluable for ER H score with samples for this timepoint.
Estrogen receptor (ER) Histologic (H) Score is calculated as the sum of intensity of staining (0 to 3+) multiplied by the proportion (%) of cells staining positive and has a dynamic range of 0 to 300. ER H score pre-treatment was determined for each of the three treatment groups.
Outcome measures
| Measure |
Fulvestrant
n=36 Participants
500 mg, administered as two 250 mg IM injections, given on days 1 and 14
Fulvestrant
|
Anastrozole
n=46 Participants
1mg given orally daily for 21 days
Anastrozole
|
Tamoxifen
n=50 Participants
Tamoxifen is administered orally, at a dose of 20 mg,daily, for 21 days
Tamoxifen
|
|---|---|---|---|
|
Pre-treatment Estrogen Receptor H Score
|
270 Pre-treatment ER H Score
Inter-Quartile Range 43 • Interval 240.0 to 315.0
|
248 Pre-treatment ER H Score
Inter-Quartile Range 58 • Interval 215.0 to 270.0
|
263 Pre-treatment ER H Score
Inter-Quartile Range 40 • Interval 243.0 to 283.0
|
SECONDARY outcome
Timeframe: Day 21-27Population: Treated patients who were evaluable for ER H score with samples provided for this endpoint.
Estrogen receptor (ER) Histologic (H) Score is calculated as the sum of intensity of staining (0 to 3+) multiplied by the proportion (%) of cells staining positive and has a dynamic range of 0 to 300. ER H score was determined in each of the three post treatment groups.
Outcome measures
| Measure |
Fulvestrant
n=37 Participants
500 mg, administered as two 250 mg IM injections, given on days 1 and 14
Fulvestrant
|
Anastrozole
n=49 Participants
1mg given orally daily for 21 days
Anastrozole
|
Tamoxifen
n=51 Participants
Tamoxifen is administered orally, at a dose of 20 mg,daily, for 21 days
Tamoxifen
|
|---|---|---|---|
|
Post-treatment Estrogen Receptor (ER) H Score
|
127.5 Post-treatment ER H score
Inter-Quartile Range 80 • Interval 80.0 to 160.0
|
242.5 Post-treatment ER H score
Inter-Quartile Range 30 • Interval 230.0 to 260.0
|
230 Post-treatment ER H score
Inter-Quartile Range 20 • Interval 220.0 to 240.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Treated patients who were evaluable for PR H score with samples for this timepoint.
Progesterone receptor (PR) Histologic (H) Score is calculated as the sum of intensity of staining (0 to 3+) multiplied by the proportion (%) of cells staining positive and has a dynamic range of 0 to 300. PR H Score was determined at baseline.
Outcome measures
| Measure |
Fulvestrant
n=29 Participants
500 mg, administered as two 250 mg IM injections, given on days 1 and 14
Fulvestrant
|
Anastrozole
n=42 Participants
1mg given orally daily for 21 days
Anastrozole
|
Tamoxifen
n=43 Participants
Tamoxifen is administered orally, at a dose of 20 mg,daily, for 21 days
Tamoxifen
|
|---|---|---|---|
|
Pre-treatment Progesterone Receptor (PR) H Score
|
120 Pre-treatment PR H score
Inter-Quartile Range 209 • Interval 20.0 to 200.0
|
125 Pre-treatment PR H score
Inter-Quartile Range 228 • Interval 30.0 to 258.0
|
140 Pre-treatment PR H score
Inter-Quartile Range 203 • Interval 10.0 to 250.0
|
SECONDARY outcome
Timeframe: Day 21-27Population: Treated patients who were evaluable for PR H score with samples for this timepoint.
Progesterone receptor (PR) Histologic (H) Score is calculated as the sum of intensity of staining (0 to 3+) multiplied by the proportion (%) of cells staining positive and has a dynamic range of 0 to 300. PR H score was determined post treatment.
Outcome measures
| Measure |
Fulvestrant
n=35 Participants
500 mg, administered as two 250 mg IM injections, given on days 1 and 14
Fulvestrant
|
Anastrozole
n=46 Participants
1mg given orally daily for 21 days
Anastrozole
|
Tamoxifen
n=45 Participants
Tamoxifen is administered orally, at a dose of 20 mg,daily, for 21 days
Tamoxifen
|
|---|---|---|---|
|
Post-treatment Progesterone Receptor (PR) H Score
|
27.5 Post-treatment PR H score
Inter-Quartile Range 45 • Interval 0.0 to 90.0
|
10 Post-treatment PR H score
Inter-Quartile Range 35 • Interval 0.0 to 70.0
|
160 Post-treatment PR H score
Inter-Quartile Range 190 • Interval 80.0 to 260.0
|
Adverse Events
Fulvestrant
Anastrozole
Tamoxifen
Serious adverse events
| Measure |
Fulvestrant
n=62 participants at risk
500 mg, administered as two 250 mg IM injections, given on days 1 and 14
Fulvestrant
|
Anastrozole
n=66 participants at risk
1mg given orally daily for 21 days
Anastrozole
|
Tamoxifen
n=73 participants at risk
Tamoxifen is administered orally, at a dose of 20 mg,daily, for 21 days
Tamoxifen
|
|---|---|---|---|
|
Vascular disorders
Hematoma
|
0.00%
0/62 • Adverse Events data collected for 7 years, 3 months
|
1.5%
1/66 • Adverse Events data collected for 7 years, 3 months
|
0.00%
0/73 • Adverse Events data collected for 7 years, 3 months
|
Other adverse events
| Measure |
Fulvestrant
n=62 participants at risk
500 mg, administered as two 250 mg IM injections, given on days 1 and 14
Fulvestrant
|
Anastrozole
n=66 participants at risk
1mg given orally daily for 21 days
Anastrozole
|
Tamoxifen
n=73 participants at risk
Tamoxifen is administered orally, at a dose of 20 mg,daily, for 21 days
Tamoxifen
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/62 • Adverse Events data collected for 7 years, 3 months
|
1.5%
1/66 • Adverse Events data collected for 7 years, 3 months
|
0.00%
0/73 • Adverse Events data collected for 7 years, 3 months
|
|
General disorders
Fatigue
|
0.00%
0/62 • Adverse Events data collected for 7 years, 3 months
|
0.00%
0/66 • Adverse Events data collected for 7 years, 3 months
|
1.4%
1/73 • Adverse Events data collected for 7 years, 3 months
|
|
General disorders
Infusion related reaction
|
1.6%
1/62 • Adverse Events data collected for 7 years, 3 months
|
0.00%
0/66 • Adverse Events data collected for 7 years, 3 months
|
0.00%
0/73 • Adverse Events data collected for 7 years, 3 months
|
|
Vascular disorders
Hypertension
|
1.6%
1/62 • Adverse Events data collected for 7 years, 3 months
|
3.0%
2/66 • Adverse Events data collected for 7 years, 3 months
|
5.5%
4/73 • Adverse Events data collected for 7 years, 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place