Trial Outcomes & Findings for Letrozole in Preventing Breast Cancer in Postmenopausal Women (NCT NCT00090857)
NCT ID: NCT00090857
Last Updated: 2018-03-30
Results Overview
The bone mineral density (BMD) test was comprised of the following 4 measurements \[total density (g/cm\^2)\]: lumbar, femoral neck, trochanter, hip.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.
Results posted on
2018-03-30
Participant Flow
Patients enrolled from February 2002 through August 2007.
In this chemoprevention trial, postmenopausal women were screened and eligible based on serum estradiol levels. Of 405 women screened, 381 were eligible for blood draw. Of these 381 women eligible for blood draw, 87 were eligible for randomization based on serum estradiol level (\>/=0.9 ng/dL). There were 38 women who declined to be randomized.
Participant milestones
| Measure |
Letrozole
Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
Placebo
Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
16
|
|
Overall Study
COMPLETED
|
29
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Letrozole
Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
Placebo
Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Adverse Event
|
2
|
2
|
Baseline Characteristics
Letrozole in Preventing Breast Cancer in Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Letrozole
n=33 Participants
Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
Placebo
n=16 Participants
Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
52.5 years
n=7 Participants
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
16 participants
n=7 Participants
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.Population: The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of lumbar density.
The bone mineral density (BMD) test was comprised of the following 4 measurements \[total density (g/cm\^2)\]: lumbar, femoral neck, trochanter, hip.
Outcome measures
| Measure |
Letrozole
n=29 Participants
Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
Placebo
n=13 Participants
Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
|---|---|---|
|
Change in Lumbar Density From Baseline to 12 Months
|
-0.036 g/cm^2
Interval -0.092 to 0.272
|
-0.021 g/cm^2
Interval -0.18 to 0.064
|
PRIMARY outcome
Timeframe: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.Population: The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of femoral neck density.
The bone mineral density (BMD) test was comprised of the following 4 measurements \[total density (g/cm\^2)\]: lumbar, femoral neck, trochanter, hip.
Outcome measures
| Measure |
Letrozole
n=28 Participants
Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
Placebo
n=13 Participants
Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
|---|---|---|
|
Change in Femoral Neck Density From Baseline to 12 Months
|
-0.0065 g/cm^2
Interval -0.097 to 0.068
|
-0.013 g/cm^2
Interval -0.13 to 0.029
|
PRIMARY outcome
Timeframe: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.Population: The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of trochanter density.
The bone mineral density (BMD) test was comprised of the following 4 measurements \[total density (g/cm\^2)\]: lumbar, femoral neck, trochanter, hip.
Outcome measures
| Measure |
Letrozole
n=27 Participants
Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
Placebo
n=13 Participants
Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
|---|---|---|
|
Change in Trochanter Density From Baseline to 12 Months
|
-0.017 g/cm^2
Interval -0.059 to 0.023
|
-0.009 g/cm^2
Interval -0.059 to 0.015
|
PRIMARY outcome
Timeframe: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.Population: The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of hip density.
The bone mineral density (BMD) test was comprised of the following 4 measurements \[total density (g/cm\^2)\]: lumbar, femoral neck, trochanter, hip.
Outcome measures
| Measure |
Letrozole
n=28 Participants
Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
Placebo
n=13 Participants
Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
|---|---|---|
|
Change in Hip Density From Baseline to 12 Months
|
-0.0275 g/cm^2
Interval -0.082 to 0.035
|
-0.001 g/cm^2
Interval -0.075 to 0.025
|
SECONDARY outcome
Timeframe: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.Population: The analysis dataset is comprised of all randomized participants.
Participants reported worst grade hot flashes: 01: mild (\<1qd) or 02: moderate (\>1qd) during 12 months of treatment.
Outcome measures
| Measure |
Letrozole
n=33 Participants
Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
Placebo
n=16 Participants
Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
|---|---|---|
|
Worst Grade Hot Flashes
None
|
14 Participants
|
9 Participants
|
|
Worst Grade Hot Flashes
Mild (<1 qd)
|
5 Participants
|
3 Participants
|
|
Worst Grade Hot Flashes
Moderate
|
11 Participants
|
4 Participants
|
|
Worst Grade Hot Flashes
Missing
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.Participants reported worst grade muscle aches/pains defined as grade 01: mild, 02: moderate, 03: severe (CTCAEv3) or 04: disabling (CTCAEv3) during 12 months of treatment.
Outcome measures
| Measure |
Letrozole
n=33 Participants
Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
Placebo
n=18 Participants
Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
|---|---|---|
|
Worst Grade Muscle Aches/Pains
None
|
14 Participants
|
13 Participants
|
|
Worst Grade Muscle Aches/Pains
Mild
|
8 Participants
|
2 Participants
|
|
Worst Grade Muscle Aches/Pains
Moderate
|
7 Participants
|
1 Participants
|
|
Worst Grade Muscle Aches/Pains
Severe
|
1 Participants
|
0 Participants
|
|
Worst Grade Muscle Aches/Pains
Missing
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.Population: The analysis dataset is comprised of all randomized participants.
Participants reported worst grade nausea grade 01: able to eat, 02: oral intake significantly decreased, 03: no significant intake, requiring IV fluids during 12 months of treatment.
Outcome measures
| Measure |
Letrozole
n=33 Participants
Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
Placebo
n=16 Participants
Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
|---|---|---|
|
Worst Grade Nausea
None
|
23 Participants
|
15 Participants
|
|
Worst Grade Nausea
Able to Eat
|
5 Participants
|
1 Participants
|
|
Worst Grade Nausea
Oral Intake Significantly Decreased
|
1 Participants
|
0 Participants
|
|
Worst Grade Nausea
Missing
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.Population: The analysis dataset is comprised of all randomized participants.
Participants reported worst grade vomiting grade 01: 1x in 24 hours, 02: 2-5x in 24 hours, 03: \>/= 6x in 24 hours, grade 04: requiring parenteral nutrition/intensive care during 12 months of treatment.
Outcome measures
| Measure |
Letrozole
n=33 Participants
Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
Placebo
n=16 Participants
Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
|---|---|---|
|
Worst Grade Vomiting
None
|
28 Participants
|
15 Participants
|
|
Worst Grade Vomiting
1x in 24 hours
|
1 Participants
|
0 Participants
|
|
Worst Grade Vomiting
2-5x in 24 hours
|
0 Participants
|
1 Participants
|
|
Worst Grade Vomiting
Missing
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.Population: The analysis dataset is comprised of all randomized participants.
Participants reported worst grade abdominal pain: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.
Outcome measures
| Measure |
Letrozole
n=33 Participants
Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
Placebo
n=16 Participants
Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
|---|---|---|
|
Worst Grade Abdominal Pain
None
|
27 Participants
|
16 Participants
|
|
Worst Grade Abdominal Pain
Mild
|
3 Participants
|
0 Participants
|
|
Worst Grade Abdominal Pain
Missing
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.Participants reported worst grade bone pain: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.
Outcome measures
| Measure |
Letrozole
n=33 Participants
Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
Placebo
n=16 Participants
Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
|---|---|---|
|
Worst Grade Bone Pain
None
|
22 Participants
|
12 Participants
|
|
Worst Grade Bone Pain
Mild
|
2 Participants
|
3 Participants
|
|
Worst Grade Bone Pain
Moderate
|
6 Participants
|
1 Participants
|
|
Worst Grade Bone Pain
Missing
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.Participants reported worst grade headache: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.
Outcome measures
| Measure |
Letrozole
n=33 Participants
Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
Placebo
n=16 Participants
Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
|---|---|---|
|
Worst Grade Headache
None
|
20 Participants
|
11 Participants
|
|
Worst Grade Headache
Mild
|
7 Participants
|
3 Participants
|
|
Worst Grade Headache
Moderate
|
3 Participants
|
2 Participants
|
|
Worst Grade Headache
Missing
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.Participants reported worst grade fatigue: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.
Outcome measures
| Measure |
Letrozole
n=33 Participants
Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
Placebo
n=16 Participants
Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
|---|---|---|
|
Worst Grade Fatigue
None
|
19 Participants
|
11 Participants
|
|
Worst Grade Fatigue
Mild
|
6 Participants
|
2 Participants
|
|
Worst Grade Fatigue
Moderate
|
5 Participants
|
3 Participants
|
|
Worst Grade Fatigue
Missing
|
3 Participants
|
0 Participants
|
Adverse Events
Letrozole
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Letrozole
n=33 participants at risk
Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
Placebo
n=16 participants at risk
Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
|---|---|---|
|
Nervous system disorders
Pain - Head/Headache
|
3.0%
1/33 • Number of events 1 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
0.00%
0/16 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
3.0%
1/33 • Number of events 1 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
0.00%
0/16 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus / Itching
|
3.0%
1/33 • Number of events 1 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
0.00%
0/16 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
Other adverse events
| Measure |
Letrozole
n=33 participants at risk
Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
Placebo
n=16 participants at risk
Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
3.0%
1/33 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
0.00%
0/16 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
6.1%
2/33 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
6.2%
1/16 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
|
Reproductive system and breast disorders
Vaginitis (not due to infection)
|
3.0%
1/33 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
0.00%
0/16 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
|
Nervous system disorders
Vasovagal episode
|
0.00%
0/33 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
6.2%
1/16 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
|
Nervous system disorders
Dizziness
|
3.0%
1/33 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
0.00%
0/16 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
|
Investigations
Weight gain
|
3.0%
1/33 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
0.00%
0/16 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
3.0%
1/33 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
0.00%
0/16 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
|
Vascular disorders
Hot flashes/flushes
|
3.0%
1/33 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
0.00%
0/16 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
|
General disorders
Pain - Chest/thorax NOS
|
3.0%
1/33 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
0.00%
0/16 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
3.0%
1/33 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
0.00%
0/16 • Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).
Serious adverse events (SAEs) per protocol were defined as follows: 1) death, 2) a life-threatening adverse drug experience, 3) inpatient hospitalization or prolongation of existing hospitalization, 4) a persistent or significant disability/incapacity, or 5) a congenital anomaly/birth defect. All remaining AEs are Other AEs. Of note, secondary outcome measures 5-12 provide data on pre-specified analyses of key symptoms pertaining to use of the experimental treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place