Trial Outcomes & Findings for GCC 1366: Anti-Proliferative Response to NeoAdjuvant AIs in Overweight and Obese Patients (NCT NCT02095184)
NCT ID: NCT02095184
Last Updated: 2026-04-15
Results Overview
Core biopsy
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
2-4 weeks Post-treatment
Results posted on
2026-04-15
Participant Flow
Participant milestones
| Measure |
Cohort 1: Normal Weight Anastrozole
Cohort 1: Patients with BMI \< 25.0 kg/m2 treated with anastrozole
Anastrozole: 1 mg daily
|
Cohort 2: Overweight Anastrozole
Cohort 2: Patients with BMI ≥ 25.0-29.9 kg/m2 treated with anastrozole
Anastrozole: 1 mg daily
|
Cohort 3: Obese
Cohort 3: Patients with BMI ≥ 30 kg/m2 treated with anastrozole
Anastrozole: 1 mg daily
|
Cohort 4: Normal Weight Letrozole
Cohort 4: Patients with BMI \< 25.0 kg/m2 treating with letrozole
Letrozole: 2.5 mg daily
|
Cohort 5: Overweight Letrozole
Cohort 5: Patients with BMI ≥ 25.0-29.9 kg/m2 treating with letrozole
Letrozole: 2.5 mg daily
|
Cohort 6: Obese Letrozole
Cohort 6: Patients with BMI ≥ 30 kg/m2 treating with letrozole
Letrozole: 2.5 mg daily
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
6
|
9
|
16
|
2
|
7
|
|
Overall Study
COMPLETED
|
1
|
6
|
6
|
14
|
2
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
2
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GCC 1366: Anti-Proliferative Response to NeoAdjuvant AIs in Overweight and Obese Patients
Baseline characteristics by cohort
| Measure |
Cohort 1: Normal Weight Anastrozole
n=2 Participants
Cohort 1: Patients with BMI \< 25.0 kg/m2 treated with anastrozole
Anastrozole: 1 mg daily
|
Cohort 2: Overweight Anastrozole
n=6 Participants
Cohort 2: Patients with BMI ≥ 25.0-29.9 kg/m2 treated with anastrozole
Anastrozole: 1 mg daily
|
Cohort 3: Obese
n=9 Participants
Cohort 3: Patients with BMI ≥ 30 kg/m2 treated with anastrozole
Anastrozole: 1 mg daily
|
Cohort 4: Normal Weight Letrozole
n=16 Participants
Cohort 4: Patients with BMI \< 25.0 kg/m2 treating with letrozole
Letrozole: 2.5 mg daily
|
Cohort 5: Overweight Letrozole
n=2 Participants
Cohort 5: Patients with BMI ≥ 25.0-29.9 kg/m2 treating with letrozole
Letrozole: 2.5 mg daily
|
Cohort 6: Obese Letrozole
n=7 Participants
Cohort 6: Patients with BMI ≥ 30 kg/m2 treating with letrozole
Letrozole: 2.5 mg daily
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
4 Participants
n=386 Participants
|
7 Participants
n=13 Participants
|
1 Participants
n=43 Participants
|
4 Participants
n=1 Participants
|
20 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
5 Participants
n=386 Participants
|
9 Participants
n=13 Participants
|
1 Participants
n=43 Participants
|
3 Participants
n=1 Participants
|
22 Participants
n=8 Participants
|
|
Age, Continuous
|
59 years
n=193 Participants
|
68 years
n=193 Participants
|
66 years
n=386 Participants
|
66 years
n=13 Participants
|
65 years
n=43 Participants
|
71 years
n=1 Participants
|
66 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=193 Participants
|
6 Participants
n=193 Participants
|
9 Participants
n=386 Participants
|
16 Participants
n=13 Participants
|
2 Participants
n=43 Participants
|
7 Participants
n=1 Participants
|
42 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
1 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
6 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
3 Participants
n=1 Participants
|
14 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
6 Participants
n=386 Participants
|
9 Participants
n=13 Participants
|
1 Participants
n=43 Participants
|
3 Participants
n=1 Participants
|
22 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=43 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=193 Participants
|
6 participants
n=193 Participants
|
9 participants
n=386 Participants
|
16 participants
n=13 Participants
|
2 participants
n=43 Participants
|
7 participants
n=1 Participants
|
42 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 2-4 weeks Post-treatmentPopulation: The study was terminated early due to slow accrual related to changing clinical practice patterns and insurance coverage barriers for required study tests. Although limited screening/consent occurred, no ppts were measured/analyzed, no data available for analysis for outcome measures. The calculation required for this measure was omitted, PI did not complete the assessment nor collect information before study termination. Due to IRB closure, the protocol was not updated to remove this measure.
Core biopsy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: B,0-Prior to starting anastrozole or letrozolePopulation: The study was terminated early due to slow accrual related to changing clinical practice patterns and insurance coverage barriers for required study tests. Although limited screening/consent occurred, no ppts were measured/analyzed, no data available for analysis for outcome measures. The evaluation required for this measure was omitted, PI did not complete the assessment nor collect information before study termination. Due to IRB closure, the protocol was not updated to remove this measure.
GP88-6ml Blood Serum Sample
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: B,1-On the day of surgery or within 3 days of surgeryPopulation: The study was terminated early due to slow accrual related to changing clinical practice patterns and insurance coverage barriers for required study tests. Although limited screening/consent occurred, no ppts were measured/analyzed, no data available for analysis for outcome measures. The evaluation required for this measure was omitted, PI did not complete the assessment nor collect information before study termination. Due to IRB closure, the protocol was not updated to remove this measure.
GP88-6ml Blood Serum Sample
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: B,2-obtained 2-4 weeks after initiation of AI therapy( for persons rec. extended neoadjuvant tx)Population: The study was terminated early due to slow accrual related to changing clinical practice patterns and insurance coverage barriers for required study tests. Although limited screening/consent occurred, no ppts were measured/analyzed, no data available for analysis for outcome measures. The evaluation required for this measure was omitted, PI did not complete the assessment nor collect information before study termination. Due to IRB closure, the protocol was not updated to remove this measure.
GP88-6ml Blood Serum Sample
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: The study was terminated early due to slow accrual related to changing clinical practice patterns and insurance coverage barriers for required study tests. Although limited screening/consent occurred, no ppts were measured/analyzed, no data available for analysis for outcome measures. The assessment required for this measure was omitted, PI did not complete the assessment nor collect information before study termination. Due to IRB closure, the protocol was not updated to remove this measure.
10ml Blood Serum Sample
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2-4 weeks Post treatmentPopulation: The study was terminated early due to slow accrual related to changing clinical practice patterns and insurance coverage barriers for required study tests. Although limited screening/consent occurred, no ppts were measured/analyzed, no data available for analysis for outcome measures. The assessment required for this measure was omitted, PI did not complete the assessment nor collect information before study termination. Due to IRB closure, the protocol was not updated to remove this measure.
10ml Blood Serum Sample
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: The study was terminated early due to slow accrual related to changing clinical practice patterns and insurance coverage barriers for required study tests. Although limited screening/consent occurred, no ppts were measured/analyzed, no data available for analysis for outcome measures. The evaluation required for this measure was omitted, PI did not complete the assessment nor collect information before study termination. Due to IRB closure, the protocol was not updated to remove this measure.
(IHC)--Immunohistochemistry
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2-4 weeks Post-TreatmentPopulation: The study was terminated early due to slow accrual related to changing clinical practice patterns and insurance coverage barriers for required study tests. Although limited screening/consent occurred, no ppts were measured/analyzed, no data available for analysis for outcome measures. The evaluation required for this measure was omitted, PI did not complete the assessment nor collect information before study termination. Due to IRB closure, the protocol was not updated to remove this measure.
(IHC)--Immunohistochemistry
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline(T0)Population: The study was terminated early due to slow accrual related to changing clinical practice patterns and insurance coverage barriers for required study tests. Although limited screening/consent occurred, no ppts were measured/analyzed, no data available for analysis for outcome measures. The evaluation required for this measure was omitted, PI did not complete the assessment nor collect information before study termination. Due to IRB closure, the protocol was not updated to remove this measure.
Tumor Tissue Assay
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2-4 Post-treatmentPopulation: The study was terminated early due to slow accrual related to changing clinical practice patterns and insurance coverage barriers for required study tests. Although limited screening/consent occurred, no ppts were measured/analyzed, no data available for analysis for outcome measures. The evaluation required for this measure was omitted, PI did not complete the assessment nor collect information before study termination. Due to IRB closure, the protocol was not updated to remove this measure.
Tumor Tissue Assay
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: B-010ml Blood Serum Sample
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: B-110ml Blood Serum Sample
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: B-210ml Blood Serum Sample
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1: Normal Weight Anastrozole
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2: Overweight Anastrozole
Serious events: 0 serious events
Other events: 5 other events
Deaths: 1 deaths
Cohort 3: Obese
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 4: Normal Weight Letrozole
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Cohort 5: Overweight Letrozole
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 6: Obese Letrozole
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Normal Weight Anastrozole
n=2 participants at risk
Cohort 1: Patients with BMI \< 25.0 kg/m2 treated with anastrozole
Anastrozole: 1 mg daily
|
Cohort 2: Overweight Anastrozole
n=6 participants at risk
Cohort 2: Patients with BMI ≥ 25.0-29.9 kg/m2 treated with anastrozole
Anastrozole: 1 mg daily
|
Cohort 3: Obese
n=9 participants at risk
Cohort 3: Patients with BMI ≥ 30 kg/m2 treated with anastrozole
Anastrozole: 1 mg daily
|
Cohort 4: Normal Weight Letrozole
n=16 participants at risk
Cohort 4: Patients with BMI \< 25.0 kg/m2 treating with letrozole
Letrozole: 2.5 mg daily
|
Cohort 5: Overweight Letrozole
n=2 participants at risk
Cohort 5: Patients with BMI ≥ 25.0-29.9 kg/m2 treating with letrozole
Letrozole: 2.5 mg daily
|
Cohort 6: Obese Letrozole
n=7 participants at risk
Cohort 6: Patients with BMI ≥ 30 kg/m2 treating with letrozole
Letrozole: 2.5 mg daily
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
abdominal pain, nausea and vomiting
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
6.2%
1/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
14.3%
1/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
Other adverse events
| Measure |
Cohort 1: Normal Weight Anastrozole
n=2 participants at risk
Cohort 1: Patients with BMI \< 25.0 kg/m2 treated with anastrozole
Anastrozole: 1 mg daily
|
Cohort 2: Overweight Anastrozole
n=6 participants at risk
Cohort 2: Patients with BMI ≥ 25.0-29.9 kg/m2 treated with anastrozole
Anastrozole: 1 mg daily
|
Cohort 3: Obese
n=9 participants at risk
Cohort 3: Patients with BMI ≥ 30 kg/m2 treated with anastrozole
Anastrozole: 1 mg daily
|
Cohort 4: Normal Weight Letrozole
n=16 participants at risk
Cohort 4: Patients with BMI \< 25.0 kg/m2 treating with letrozole
Letrozole: 2.5 mg daily
|
Cohort 5: Overweight Letrozole
n=2 participants at risk
Cohort 5: Patients with BMI ≥ 25.0-29.9 kg/m2 treating with letrozole
Letrozole: 2.5 mg daily
|
Cohort 6: Obese Letrozole
n=7 participants at risk
Cohort 6: Patients with BMI ≥ 30 kg/m2 treating with letrozole
Letrozole: 2.5 mg daily
|
|---|---|---|---|---|---|---|
|
General disorders
Arthralgia
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
16.7%
1/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
11.1%
1/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
6.2%
1/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
14.3%
1/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
14.3%
1/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
General disorders
Bilateral axilla pain
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
14.3%
1/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
Gastrointestinal disorders
bladder mass
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
6.2%
1/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
General disorders
breast pain
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
11.1%
1/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
General disorders
Bruising
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
11.1%
1/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
6.2%
1/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
Cardiac disorders
chest pain
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
14.3%
1/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
6.2%
1/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
6.2%
1/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
General disorders
Nausea
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
33.3%
2/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
18.8%
3/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
General disorders
Vomiting
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
16.7%
1/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
18.8%
3/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
11.1%
1/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
25.0%
4/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
General disorders
Fatigue/Decreased energy
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
16.7%
1/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
11.1%
1/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
6.2%
1/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
42.9%
3/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
General disorders
Pain (all types)
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
16.7%
1/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
66.7%
6/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
43.8%
7/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
50.0%
1/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
28.6%
2/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
General disorders
Myalgia
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
12.5%
2/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
14.3%
1/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
General disorders
Headache
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
22.2%
2/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
6.2%
1/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
General disorders
Dizziness
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
12.5%
2/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
General disorders
Hypertension / Elevated BP
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
43.8%
7/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
100.0%
2/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
General disorders
Obesity
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
18.8%
3/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
100.0%
2/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
General disorders
Hyperglycemia / Elevated A1C
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
18.8%
3/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
50.0%
1/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
Skin and subcutaneous tissue disorders
triple point with small scab w/some redness immediately around the incision
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
11.1%
1/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
6.2%
1/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
0.00%
0/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
|
General disorders
Hot flashes
|
0.00%
0/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
16.7%
1/6 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
22.2%
2/9 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
18.8%
3/16 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
50.0%
1/2 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
14.3%
1/7 • 30 days after the last dose of anastrozole or letrozole and assessment performed within 4 weeks after surgery.
|
Additional Information
Suliat Nurudeen, MD
University of Maryland Greenebaum Comprehensive Cancer Center
Phone: 410-328-7320
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place