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Letrozole in Treating Postmenopausal Women With Ductal Carcinoma in Situ

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01439711
Recruitment Status : Completed
First Posted : September 23, 2011
Results First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: letrozole
Procedure: MRI
Procedure: conventional surgery
Enrollment 108
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Letrozole + MRI
Hide Arm/Group Description Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
Period Title: Overall Study
Started 108
Completed 68
Not Completed 40
Reason Not Completed
Ineligible             13
Cancel             3
Progression Prior to Beginning Tx             1
Adverse Event             5
Withdrawal by Subject             3
Progression During Active Tx             3
Noncompliance             3
No MRI             9
Arm/Group Title Letrozole + MRI
Hide Arm/Group Description Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
Overall Number of Baseline Participants 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 68 participants
63.2  (8.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
Female
68
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 68 participants
68
 100.0%
1.Primary Outcome
Title Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 3 (V3)
Hide Description Mean total MRI FTV change from baseline to month 3 (V3): For patients with more than one measureable lesion on the MRI, the sum over all measureable lesions on the MRI was calculated at each time point. V3 was calculated by subtracting the total MRI FTV measured (i.e. the sum over all lesions present with MRI FTV measurements) at 3 months from the total MRI FTV measured at baseline. For V3 the raw change in the volume will be calculated for each patient and a mean and 95% confidence interval will be constructed using two-sided t-tests.
Time Frame up to 3 months from start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Letrozole + MRI
Hide Arm/Group Description:
Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
Overall Number of Participants Analyzed 68
Mean (95% Confidence Interval)
Unit of Measure: cubic centimeters
-1.93
(-2.87 to -0.98)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Letrozole + MRI
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 6 (V6)
Hide Description Mean total MRI FTV change from baseline to month 6 (V6): For patients with more than one measureable lesion on the MRI, the sum over all measureable lesions on the MRI was calculated at each time point. V6 was calculated by subtracting the total MRI FTV measured at 6 months from the total MRI FTV measured at baseline. For V6 the raw change in the volume will be calculated for each patient and a mean and 95% confidence interval will be constructed using two-sided t-tests.
Time Frame up to 6 months from start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Letrozole + MRI
Hide Arm/Group Description:
Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
Overall Number of Participants Analyzed 68
Mean (95% Confidence Interval)
Unit of Measure: cubic centimeters
-1.82
(-2.75 to -0.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Letrozole + MRI
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Mean Total MRI Tumor Diameter Change From Baseline to Month 3
Hide Description To ascertain the change in maximum tumor diameter from baseline to 3 months (D3) the same methods as in Primary outcome #1 will be used but on diameter instead of volume. For patients with more than one lesion longest diameter measurement, the sum of all lesion longest diameter measurements was calculated.
Time Frame 3-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Letrozole + MRI
Hide Arm/Group Description:
Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
Overall Number of Participants Analyzed 68
Mean (95% Confidence Interval)
Unit of Measure: millimeters
-10.3
(-13.94 to -6.66)
4.Secondary Outcome
Title Change in Maximum Diameter at 6-months Based on Mammographic Measurement (MD6)
Hide Description Change in maximum diameter at 6-months based on mammographic measurement (MD6) will be estimated using the methods in Primary Outcome #1, but using the mammographic measurements instead.
Time Frame 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed a mammogram at both time points (baseline and month 6) with measurements available were included in this analysis.
Arm/Group Title Letrozole + MRI
Hide Arm/Group Description:
Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
Overall Number of Participants Analyzed 52
Mean (95% Confidence Interval)
Unit of Measure: millimeters
-3.31
(-7.0 to 0.38)
5.Secondary Outcome
Title Type of Primary Surgery (Mastectomy or Lumpectomy)
Hide Description Rate of Mastectomy will be estimated as the number of mastectomies divided by the number of surgeries. A 95% confidence interval will be constructed using exact binomial methods. Rate of Lumpectomy will be estimated as the number of lumpectomies divided by the number of surgeries. A 95% confidence interval will be constructed using exact binomial methods.
Time Frame up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who underwent surgery were included in this analysis.
Arm/Group Title Letrozole + MRI
Hide Arm/Group Description:
Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
Overall Number of Participants Analyzed 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of surgeries
Rate of Mastectomy
7
(2 to 16)
Rate of Lumpectomy
93
(84 to 98)
6.Secondary Outcome
Title Number of Re-excisions Required to Obtain Clear Margins
Hide Description [Not Specified]
Time Frame 3-months and 6-months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Extent of Residual DCIS Post Surgery
Hide Description [Not Specified]
Time Frame Up to 6 months post-surgery
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Presence of Invasive Cancer at Surgery
Hide Description [Not Specified]
Time Frame 3-months and 6-months
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Size of Margins (Smallest) at Surgery
Hide Description [Not Specified]
Time Frame 3-months and 6-months
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hide Description The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event at least possibly related to the study treatment are reported below.
Time Frame Up to 6 months post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who had completed the study and had an Adverse Event Form submitted were included in this analysis.
Arm/Group Title Letrozole + MRI
Hide Arm/Group Description:
Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
Overall Number of Participants Analyzed 67
Measure Type: Count of Participants
Unit of Measure: Participants
Allergic reaction
31
  46.3%
Cholesterol high
7
  10.4%
Gastrointestinal disorder
2
   3.0%
Hot flashes
1
   1.5%
11.Secondary Outcome
Title Mean Total MRI Tumor Diameter Change From Baseline to Month 6
Hide Description Mean total MRI tumor diameter change from baseline to month 6: To ascertain the change in maximum tumor diameter from baseline to 6 months (D6) the same methods as in Primary Outcome #2 will be used but on diameter instead of volume.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Letrozole + MRI
Hide Arm/Group Description:
Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
Overall Number of Participants Analyzed 68
Mean (95% Confidence Interval)
Unit of Measure: millimeters
-16.66
(-21.09 to -12.23)
12.Secondary Outcome
Title Mean Total MRI Tumor Diameter Change From Baseline to Month 6
Hide Description To ascertain the change in maximum tumor diameter from baseline to 6 months (D6) the same methods as in Primary outcome #2 will be used but on diameter instead of volume. For patients with more than one lesion longest diameter measurement, the sum of all lesion longest diameter measurements was calculated.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Letrozole + MRI
Hide Arm/Group Description:
Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
Overall Number of Participants Analyzed 68
Mean (95% Confidence Interval)
Unit of Measure: millimeters
-16.66
(-21.09 to -12.23)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Letrozole + MRI
Hide Arm/Group Description Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
All-Cause Mortality
Letrozole + MRI
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Letrozole + MRI
Affected / at Risk (%) # Events
Total   2/90 (2.22%)    
Cardiac disorders   
Heart failure † 1  1/90 (1.11%)  1
Restrictive cardiomyopathy † 1  1/90 (1.11%)  1
General disorders   
Fever † 1  1/90 (1.11%)  1
Metabolism and nutrition disorders   
Hypokalemia † 1  1/90 (1.11%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia † 1  1/90 (1.11%)  1
Myalgia † 1  1/90 (1.11%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify † 1  1/90 (1.11%)  1
Vascular disorders   
Hypertension † 1  2/90 (2.22%)  2
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Letrozole + MRI
Affected / at Risk (%) # Events
Total   75/90 (83.33%)    
Gastrointestinal disorders   
Gastrointestinal disorders - Other, specify † 1  5/90 (5.56%)  5
Nausea † 1  3/90 (3.33%)  4
General disorders   
Fatigue † 1  1/90 (1.11%)  2
Fever † 1  1/90 (1.11%)  1
Immune system disorders   
Allergic reaction † 1  3/90 (3.33%)  5
Injury, poisoning and procedural complications   
Fracture † 1  3/90 (3.33%)  3
Investigations   
Cholesterol high † 1  4/90 (4.44%)  6
Musculoskeletal and connective tissue disorders   
Arthralgia † 1  43/90 (47.78%)  87
Back pain † 1  1/90 (1.11%)  1
Myalgia † 1  19/90 (21.11%)  28
Osteoporosis † 1  5/90 (5.56%)  8
Nervous system disorders   
Headache † 1  1/90 (1.11%)  1
Psychiatric disorders   
Depression † 1  1/90 (1.11%)  1
Insomnia † 1  1/90 (1.11%)  1
Vascular disorders   
Hot flashes † 1  50/90 (55.56%)  103
Hypertension † 1  16/90 (17.78%)  25
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: E. Shelley Hwang MD MPH
Organization: Duke University Medical Center
Phone: 919-684-6849
EMail: shelley.hwang@duke.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01439711    
Other Study ID Numbers: CALGB-40903
CDR0000701992 ( Registry Identifier: Physician Data Query )
U10CA037447 ( U.S. NIH Grant/Contract )
NCI-2011-03452 ( Registry Identifier: NCI Clinical Trials Reporting Office )
First Submitted: September 21, 2011
First Posted: September 23, 2011
Results First Submitted: February 26, 2018
Results First Posted: March 27, 2018
Last Update Posted: March 27, 2018