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
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Sponsor:
Alliance for Clinical Trials in Oncology
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
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Study Type | Interventional |
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Study Design | Allocation: N/A; 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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Letrozole + MRI |
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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 |
Baseline Characteristics
Arm/Group Title | Letrozole + MRI | |
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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 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 68 participants | |
63.2 (8.03) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 68 participants | |
Female |
68 100.0%
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Male |
0 0.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 68 participants |
68 100.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | E. Shelley Hwang MD MPH |
Organization: | Duke University Medical Center |
Phone: | 919-684-6849 |
EMail: | shelley.hwang@duke.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |