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Letrozole in Preventing Breast Cancer in Postmenopausal Women (WISE)

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ClinicalTrials.gov Identifier: NCT00090857
Recruitment Status : Completed
First Posted : September 8, 2004
Results First Posted : June 29, 2017
Last Update Posted : March 30, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Jonsson Comprehensive Cancer Center
Information provided by (Responsible Party):
Judy E. Garber, MD, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Breast Cancer
Interventions Drug: Letrozole
Other: Placebo
Enrollment 49
Recruitment Details Patients enrolled from February 2002 through August 2007.
Pre-assignment Details 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.
Arm/Group Title Letrozole Placebo
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 33 16
Completed 29 13
Not Completed 4 3
Reason Not Completed
Lost to Follow-up             0             1
Withdrawal by Subject             2             0
Adverse Event             2             2
Arm/Group Title Letrozole Placebo Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 33 16 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 33 participants 16 participants 49 participants
56
(45 to 66)
52.5
(48 to 72)
54
(45 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 16 participants 49 participants
Female
33
 100.0%
16
 100.0%
49
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 16 participants 49 participants
33 16 49
1.Primary Outcome
Title Change in Lumbar Density From Baseline to 12 Months
Hide Description The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.
Time Frame Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of lumbar density.
Arm/Group Title Letrozole Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 29 13
Median (Full Range)
Unit of Measure: g/cm^2
-0.036
(-0.092 to 0.272)
-0.021
(-0.180 to 0.064)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Letrozole, Placebo
Comments Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Change in Femoral Neck Density From Baseline to 12 Months
Hide Description The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.
Time Frame Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of femoral neck density.
Arm/Group Title Letrozole Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 28 13
Median (Full Range)
Unit of Measure: g/cm^2
-0.0065
(-0.097 to 0.068)
-0.013
(-0.13 to 0.029)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Letrozole, Placebo
Comments Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title Change in Trochanter Density From Baseline to 12 Months
Hide Description The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.
Time Frame Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of trochanter density.
Arm/Group Title Letrozole Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 27 13
Median (Full Range)
Unit of Measure: g/cm^2
-0.017
(-0.059 to 0.023)
-0.009
(-0.059 to 0.015)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Letrozole, Placebo
Comments Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Primary Outcome
Title Change in Hip Density From Baseline to 12 Months
Hide Description The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.
Time Frame Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of hip density.
Arm/Group Title Letrozole Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 28 13
Median (Full Range)
Unit of Measure: g/cm^2
-0.0275
(-0.082 to 0.035)
-0.001
(-0.075 to 0.025)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Letrozole, Placebo
Comments Sample size for a detectable difference in the within participant change in bone density was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Worst Grade Hot Flashes
Hide Description Participants reported worst grade hot flashes: 01: mild (<1qd) or 02: moderate (>1qd) during 12 months of treatment.
Time Frame Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all randomized participants.
Arm/Group Title Letrozole Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 33 16
Measure Type: Count of Participants
Unit of Measure: Participants
None
14
  42.4%
9
  56.3%
Mild (<1 qd)
5
  15.2%
3
  18.8%
Moderate
11
  33.3%
4
  25.0%
Missing
3
   9.1%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Letrozole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Worst Grade Muscle Aches/Pains
Hide Description 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.
Time Frame Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Letrozole Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 33 18
Measure Type: Count of Participants
Unit of Measure: Participants
None
14
  42.4%
13
  72.2%
Mild
8
  24.2%
2
  11.1%
Moderate
7
  21.2%
1
   5.6%
Severe
1
   3.0%
0
   0.0%
Missing
3
   9.1%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Letrozole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Worst Grade Nausea
Hide Description 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.
Time Frame Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all randomized participants.
Arm/Group Title Letrozole Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 33 16
Measure Type: Count of Participants
Unit of Measure: Participants
None
23
  69.7%
15
  93.8%
Able to Eat
5
  15.2%
1
   6.3%
Oral Intake Significantly Decreased
1
   3.0%
0
   0.0%
Missing
4
  12.1%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Letrozole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title Worst Grade Vomiting
Hide Description 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.
Time Frame Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all randomized participants.
Arm/Group Title Letrozole Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 33 16
Measure Type: Count of Participants
Unit of Measure: Participants
None
28
  84.8%
15
  93.8%
1x in 24 hours
1
   3.0%
0
   0.0%
2-5x in 24 hours
0
   0.0%
1
   6.3%
Missing
4
  12.1%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Letrozole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .88
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Secondary Outcome
Title Worst Grade Abdominal Pain
Hide Description Participants reported worst grade abdominal pain: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.
Time Frame Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all randomized participants.
Arm/Group Title Letrozole Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 33 16
Measure Type: Count of Participants
Unit of Measure: Participants
None
27
  81.8%
16
 100.0%
Mild
3
   9.1%
0
   0.0%
Missing
3
   9.1%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Letrozole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
10.Secondary Outcome
Title Worst Grade Bone Pain
Hide Description Participants reported worst grade bone pain: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.
Time Frame Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Letrozole Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 33 16
Measure Type: Count of Participants
Unit of Measure: Participants
None
22
  66.7%
12
  75.0%
Mild
2
   6.1%
3
  18.8%
Moderate
6
  18.2%
1
   6.3%
Missing
3
   9.1%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Letrozole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .60
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
11.Secondary Outcome
Title Worst Grade Headache
Hide Description Participants reported worst grade headache: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.
Time Frame Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Letrozole Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 33 16
Measure Type: Count of Participants
Unit of Measure: Participants
None
20
  60.6%
11
  68.8%
Mild
7
  21.2%
3
  18.8%
Moderate
3
   9.1%
2
  12.5%
Missing
3
   9.1%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Letrozole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .58
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
12.Secondary Outcome
Title Worst Grade Fatigue
Hide Description Participants reported worst grade fatigue: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.
Time Frame Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Letrozole Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 33 16
Measure Type: Count of Participants
Unit of Measure: Participants
None
19
  57.6%
11
  68.8%
Mild
6
  18.2%
2
  12.5%
Moderate
5
  15.2%
3
  18.8%
Missing
3
   9.1%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Letrozole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .49
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 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).
Adverse Event Reporting Description 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.
 
Arm/Group Title Letrozole Placebo
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Letrozole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)      0/16 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Letrozole Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/33 (3.03%)      0/16 (0.00%)    
Nervous system disorders     
Pain - Head/Headache  1  1/33 (3.03%)  1 0/16 (0.00%)  0
Skin and subcutaneous tissue disorders     
Urticaria (hives, welts, wheals)  1  1/33 (3.03%)  1 0/16 (0.00%)  0
Pruritus / Itching  1  1/33 (3.03%)  1 0/16 (0.00%)  0
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Letrozole Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/33 (18.18%)      2/16 (12.50%)    
General disorders     
Fatigue (asthenia, lethargy, malaise)  1  1/33 (3.03%)  0/16 (0.00%) 
Pain - Chest/thorax NOS  1  1/33 (3.03%)  0/16 (0.00%) 
Investigations     
Weight gain  1  1/33 (3.03%)  0/16 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis (non-septic)  1  1/33 (3.03%)  0/16 (0.00%) 
Pain - Muscle  1  2/33 (6.06%)  1/16 (6.25%) 
Nervous system disorders     
Vasovagal episode  1  0/33 (0.00%)  1/16 (6.25%) 
Dizziness  1  1/33 (3.03%)  0/16 (0.00%) 
Reproductive system and breast disorders     
Vaginitis (not due to infection)  1  1/33 (3.03%)  0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea (shortness of breath)  1  1/33 (3.03%)  0/16 (0.00%) 
Vascular disorders     
Hot flashes/flushes  1  1/33 (3.03%)  0/16 (0.00%) 
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Results on this study are limited due to the age of the trial and the prior departure of the coordinator who assisted with the data collection. The accrual goal was not met with many participants eligible upon screening declining randomization.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Judy E. Garber, MD, MPH
Organization: Dana-Farber Cancer Institute
Phone: 617.632.2282
EMail: Judy_Garber@dfci.harvard.edu
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Responsible Party: Judy E. Garber, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00090857     History of Changes
Obsolete Identifiers: NCT00165529, NCT00577551
Other Study ID Numbers: DFCI-00024
P50CA089393 ( U.S. NIH Grant/Contract )
P30CA006516 ( U.S. NIH Grant/Contract )
DFCI-00024
UCLA-0210012-02
First Submitted: September 7, 2004
First Posted: September 8, 2004
Results First Submitted: January 18, 2017
Results First Posted: June 29, 2017
Last Update Posted: March 30, 2018