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Letrozole in Treating Postmenopausal Women With Ductal Carcinoma in Situ

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Letrozole + MRI 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.

Participant Flow:   Overall Study
    Letrozole + MRI
STARTED   108 
COMPLETED   68 
NOT COMPLETED   40 
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 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Letrozole + MRI 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.

Baseline Measures
   Letrozole + MRI 
Overall Participants Analyzed 
[Units: Participants]
 68 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.2  (8.03) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      68 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   68 


  Outcome Measures

1.  Primary:   Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 3 (V3)   [ Time Frame: up to 3 months from start of treatment ]

2.  Primary:   Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 6 (V6)   [ Time Frame: up to 6 months from start of treatment ]

3.  Secondary:   Mean Total MRI Tumor Diameter Change From Baseline to Month 3   [ Time Frame: 3-months ]

4.  Secondary:   Change in Maximum Diameter at 6-months Based on Mammographic Measurement (MD6)   [ Time Frame: 6-months ]

5.  Secondary:   Type of Primary Surgery (Mastectomy or Lumpectomy)   [ Time Frame: up to 6 months ]

6.  Secondary:   Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0   [ Time Frame: Up to 6 months post surgery ]

7.  Secondary:   Mean Total MRI Tumor Diameter Change From Baseline to Month 6   [ Time Frame: 6 months ]

8.  Secondary:   Mean Total MRI Tumor Diameter Change From Baseline to Month 6   [ Time Frame: 6 months ]

9.  Secondary:   Number of Re-excisions Required to Obtain Clear Margins   [ Time Frame: 3-months and 6-months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Secondary:   Extent of Residual DCIS Post Surgery   [ Time Frame: Up to 6 months post-surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Secondary:   Presence of Invasive Cancer at Surgery   [ Time Frame: 3-months and 6-months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

12.  Secondary:   Size of Margins (Smallest) at Surgery   [ Time Frame: 3-months and 6-months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: E. Shelley Hwang MD MPH
Organization: Duke University Medical Center
phone: 919-684-6849
e-mail: shelley.hwang@duke.edu



Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01439711     History of Changes
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