Trial Outcomes & Findings for Anastrozole and Letrozole After Surgery for the Treatment of Stage I-III Breast Cancer (NCT NCT04294225)
NCT ID: NCT04294225
Last Updated: 2025-01-28
Results Overview
Percentage of women who have adequate E1 and E2 suppression (E1 \< 1.3 pg/ml and/or E2 \< 0.5) after 8-10 weeks of adjuvant anastrozole 10 mg daily having had inadequate E1 and E2 (E1 \>= 1.3 pg/ml and E2 \>= 0.5) after 8-10 weeks of adjuvant anastrozole 1 mg daily.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
161 participants
Primary outcome timeframe
24 weeks
Results posted on
2025-01-28
Participant Flow
Participant milestones
| Measure |
Treatment (Anastrozole, Letrozole)
Patients were to receive anastrozole 1 mg daily for 8 weeks (ANA1). After 8 weeks of ANA1, patients with E1 \< 1.3 pg/ml and/or E2 \< 0.5 pg/ml completed study and patients with E1 \>= 1.3 pg/ml and E2 \>= 0.5 pg/ml were to switch to anastrozole 10 mg daily (ANA10) for 8 weeks. After 8 weeks of ANA10, patients were to switch to letrozole 2.5 mg daily for 8 weeks. E1 and E2 levels were measured after this 8 week period. Patients were then go off study
|
|---|---|
|
Anastrozole 1 mg/Day
STARTED
|
158
|
|
Anastrozole 1 mg/Day
COMPLETED
|
147
|
|
Anastrozole 1 mg/Day
NOT COMPLETED
|
11
|
|
Anastrozole 10 mg/Day
STARTED
|
33
|
|
Anastrozole 10 mg/Day
COMPLETED
|
32
|
|
Anastrozole 10 mg/Day
NOT COMPLETED
|
1
|
|
Letrozole 2.5 mg/Day
STARTED
|
24
|
|
Letrozole 2.5 mg/Day
COMPLETED
|
24
|
|
Letrozole 2.5 mg/Day
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Treatment (Anastrozole, Letrozole)
Patients were to receive anastrozole 1 mg daily for 8 weeks (ANA1). After 8 weeks of ANA1, patients with E1 \< 1.3 pg/ml and/or E2 \< 0.5 pg/ml completed study and patients with E1 \>= 1.3 pg/ml and E2 \>= 0.5 pg/ml were to switch to anastrozole 10 mg daily (ANA10) for 8 weeks. After 8 weeks of ANA10, patients were to switch to letrozole 2.5 mg daily for 8 weeks. E1 and E2 levels were measured after this 8 week period. Patients were then go off study
|
|---|---|
|
Anastrozole 1 mg/Day
Discontinued due to COVID
|
1
|
|
Anastrozole 1 mg/Day
Discontinued due to adverse events
|
3
|
|
Anastrozole 1 mg/Day
Withdrawal by Subject
|
5
|
|
Anastrozole 1 mg/Day
Ineligible
|
2
|
|
Anastrozole 10 mg/Day
Withdrawal by Subject
|
1
|
Baseline Characteristics
Anastrozole and Letrozole After Surgery for the Treatment of Stage I-III Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Anastrozole, Letrozole)
n=156 Participants
Patients were to receive anastrozole 1 mg daily for 8 weeks (ANA1). After 8 weeks of ANA1, patients with E1 \< 1.3 pg/ml and/or E2 \< 0.5 pg/ml completed study and patients with E1 \>= 1.3 pg/ml and E2 \>= 0.5 pg/ml were to switch to anastrozole 10 mg daily (ANA10) for 8 weeks. After 8 weeks of ANA10, patients were to switch to letrozole 2.5 mg daily for 8 weeks. E1 and E2 levels were measured after this 8 week period. Patients were then go off study
|
|---|---|
|
Age, Customized
Age at registration (years) · 40-49
|
5 Participants
n=5 Participants
|
|
Age, Customized
Age at registration (years) · 50-59
|
46 Participants
n=5 Participants
|
|
Age, Customized
Age at registration (years) · 60-69
|
62 Participants
n=5 Participants
|
|
Age, Customized
Age at registration (years) · 70-79
|
35 Participants
n=5 Participants
|
|
Age, Customized
Age at registration (years) · 80-89
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
156 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
149 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
146 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
156 participants
n=5 Participants
|
|
BMI
Underweight/Normal
|
36 Participants
n=5 Participants
|
|
BMI
Overweight
|
54 Participants
n=5 Participants
|
|
BMI
Obese
|
62 Participants
n=5 Participants
|
|
BMI
Unknown
|
4 Participants
n=5 Participants
|
|
ECOG Performance Status
0
|
148 Participants
n=5 Participants
|
|
ECOG Performance Status
1
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Only participants that received anastrozole 10 mg daily (ANA10) and were adherent (reported taking ANA10 for 45-84 days) to treatment were analyzed
Percentage of women who have adequate E1 and E2 suppression (E1 \< 1.3 pg/ml and/or E2 \< 0.5) after 8-10 weeks of adjuvant anastrozole 10 mg daily having had inadequate E1 and E2 (E1 \>= 1.3 pg/ml and E2 \>= 0.5) after 8-10 weeks of adjuvant anastrozole 1 mg daily.
Outcome measures
| Measure |
Anastrozole 1mg Daily
n=25 Participants
Anastrozole 1mg daily
|
Anastrozolem10mg Daily
Anastrozolem10mg daily
|
Letrozole 2.5 mg Daily
Letrozole 2.5 mg Daily
|
|---|---|---|---|
|
Percentage of Participants With Adequate Estrogen Suppression After 8 Weeks of Adjuvant Anastrozole 10 mg Daily
|
76.0 percentage of participants
Interval 58.1 to 89.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Only participants that received treatment and were eligible were analyzed
Patients will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Patients were to receive anastrozole 1 mg daily for 8 weeks (ANA1). After 8 weeks of ANA1, patients with E1 \< 1.3 pg/ml and/or E2 \< 0.5 pg/ml completed study and patients with E1 \>= 1.3 pg/ml and E2 \>= 0.5 pg/ml were to switch to anastrozole 10 mg daily (ANA10) for 8 weeks. After 8 weeks of ANA10, patients were to switch to letrozole 2.5 mg daily for 8 weeks. E1 and E2 levels were measured after this 8 week period. Patients were then go off study
Outcome measures
| Measure |
Anastrozole 1mg Daily
n=156 Participants
Anastrozole 1mg daily
|
Anastrozolem10mg Daily
n=33 Participants
Anastrozolem10mg daily
|
Letrozole 2.5 mg Daily
n=24 Participants
Letrozole 2.5 mg Daily
|
|---|---|---|---|
|
Number of Participants Experiencing a Grade 3 or Greater Adverse Event
|
6 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Patients that received anastrozole 10 mg daily (ANA10) and were adherent to treatment were analyzed.
Descriptive statistics will be used. The median percent change in E1 and E2 concentrations from pre-AI levels will be presented.
Outcome measures
| Measure |
Anastrozole 1mg Daily
n=25 Participants
Anastrozole 1mg daily
|
Anastrozolem10mg Daily
Anastrozolem10mg daily
|
Letrozole 2.5 mg Daily
Letrozole 2.5 mg Daily
|
|---|---|---|---|
|
Percent Change in Estrone (E1) and Estradiol (E2) Concentrations
E1 levels
|
-97.0 percent change
Interval -98.1 to -95.0
|
—
|
—
|
|
Percent Change in Estrone (E1) and Estradiol (E2) Concentrations
E2 levels
|
-94.6 percent change
Interval -96.7 to -89.7
|
—
|
—
|
Adverse Events
Anastrozole 1mg Daily
Serious events: 4 serious events
Other events: 120 other events
Deaths: 0 deaths
Anastrozole 10mg Daily
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Letrozole 2.5 mg Daily
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anastrozole 1mg Daily
n=156 participants at risk
Anastrozole 1mg daily
|
Anastrozole 10mg Daily
n=33 participants at risk
Anastrozole 10mg daily
|
Letrozole 2.5 mg Daily
n=24 participants at risk
Letrozole 2.5 mg daily
|
|---|---|---|---|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Infections and infestations
Breast infection
|
1.3%
2/156 • Number of events 2 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/156 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
0.00%
0/24 • 6 months
|
Other adverse events
| Measure |
Anastrozole 1mg Daily
n=156 participants at risk
Anastrozole 1mg daily
|
Anastrozole 10mg Daily
n=33 participants at risk
Anastrozole 10mg daily
|
Letrozole 2.5 mg Daily
n=24 participants at risk
Letrozole 2.5 mg daily
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.5%
7/156 • Number of events 7 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Cardiac disorders
Palpitations
|
0.64%
1/156 • Number of events 1 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
0.00%
0/24 • 6 months
|
|
Eye disorders
Dry eye
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
2/156 • Number of events 2 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
0.00%
0/24 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
5/156 • Number of events 5 • 6 months
|
6.1%
2/33 • Number of events 2 • 6 months
|
4.2%
1/24 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
3.2%
5/156 • Number of events 6 • 6 months
|
3.0%
1/33 • Number of events 2 • 6 months
|
4.2%
1/24 • Number of events 1 • 6 months
|
|
General disorders
Edema limbs
|
1.3%
2/156 • Number of events 2 • 6 months
|
6.1%
2/33 • Number of events 2 • 6 months
|
0.00%
0/24 • 6 months
|
|
General disorders
Fatigue
|
58.3%
91/156 • Number of events 103 • 6 months
|
60.6%
20/33 • Number of events 32 • 6 months
|
54.2%
13/24 • Number of events 13 • 6 months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
1.9%
3/156 • Number of events 3 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
General disorders
Malaise
|
3.2%
5/156 • Number of events 5 • 6 months
|
6.1%
2/33 • Number of events 2 • 6 months
|
0.00%
0/24 • 6 months
|
|
General disorders
Pain
|
1.9%
3/156 • Number of events 3 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.64%
1/156 • Number of events 1 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
0.00%
0/24 • 6 months
|
|
Infections and infestations
Wound infection
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
13/156 • Number of events 16 • 6 months
|
12.1%
4/33 • Number of events 7 • 6 months
|
12.5%
3/24 • Number of events 3 • 6 months
|
|
Investigations
Alkaline phosphatase increased
|
1.3%
2/156 • Number of events 2 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
6.4%
10/156 • Number of events 12 • 6 months
|
9.1%
3/33 • Number of events 5 • 6 months
|
8.3%
2/24 • Number of events 2 • 6 months
|
|
Investigations
Blood bilirubin increased
|
1.3%
2/156 • Number of events 2 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Investigations
Cholesterol high
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Investigations
Investigations - Other, specify
|
1.3%
2/156 • Number of events 2 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
4.2%
1/24 • Number of events 1 • 6 months
|
|
Investigations
Lymphocyte count decreased
|
1.3%
2/156 • Number of events 2 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
0.00%
0/24 • 6 months
|
|
Investigations
Platelet count decreased
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Investigations
White blood cell decreased
|
3.2%
5/156 • Number of events 5 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
0.00%
0/24 • 6 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
59.6%
93/156 • Number of events 108 • 6 months
|
54.5%
18/33 • Number of events 33 • 6 months
|
66.7%
16/24 • Number of events 16 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.64%
1/156 • Number of events 1 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
0.00%
0/24 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
2/156 • Number of events 2 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
4.2%
1/24 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Nervous system disorders
Dizziness
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Nervous system disorders
Headache
|
5.8%
9/156 • Number of events 10 • 6 months
|
6.1%
2/33 • Number of events 3 • 6 months
|
8.3%
2/24 • Number of events 2 • 6 months
|
|
Psychiatric disorders
Anxiety
|
1.3%
2/156 • Number of events 2 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
4.2%
1/24 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Depression
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Psychiatric disorders
Insomnia
|
9.6%
15/156 • Number of events 18 • 6 months
|
12.1%
4/33 • Number of events 7 • 6 months
|
12.5%
3/24 • Number of events 3 • 6 months
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
0.64%
1/156 • Number of events 1 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
0.00%
0/24 • 6 months
|
|
Reproductive system and breast disorders
Breast pain
|
1.3%
2/156 • Number of events 2 • 6 months
|
6.1%
2/33 • Number of events 2 • 6 months
|
0.00%
0/24 • 6 months
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Reproductive system and breast disorders
Reproductive system and breast -Oth spec
|
1.3%
2/156 • Number of events 2 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
4.2%
1/24 • Number of events 1 • 6 months
|
|
Reproductive system and breast disorders
Vaginal dryness
|
3.2%
5/156 • Number of events 5 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
0.00%
0/24 • 6 months
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.64%
1/156 • Number of events 1 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
0.00%
0/24 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.1%
8/156 • Number of events 9 • 6 months
|
12.1%
4/33 • Number of events 5 • 6 months
|
12.5%
3/24 • Number of events 3 • 6 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.64%
1/156 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
0.00%
0/24 • 6 months
|
|
Vascular disorders
Hot flashes
|
66.0%
103/156 • Number of events 117 • 6 months
|
57.6%
19/33 • Number of events 33 • 6 months
|
62.5%
15/24 • Number of events 15 • 6 months
|
|
Vascular disorders
Hypertension
|
1.9%
3/156 • Number of events 3 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
4.2%
1/24 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place