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NCT01439711 · ClinicalTrials.gov registry record · Phase 2
Letrozole in Treating Postmenopausal Women With Ductal Carcinoma in Situ
A Phase 2 study of Breast Cancer, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 2
- Development phase
- 108
- Enrollment target
- 20
- Study locations
NCT01439711: Completed Phase 2 study of Breast Cancer, sponsored by Alliance for Clinical Trials in Oncology.
NCT01439711 is a Phase 2 study of Breast Cancer that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 108 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01439711, a Phase 2 study of Breast Cancer, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 108 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. PURPOSE: This phase II trial is studying how well letrozole works in treating women with ductal carcinoma in situ.
Primary Outcome
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 wil
Conditions Studied
Interventions
- PROCEDURE MRI
- DRUG letrozole
- PROCEDURE conventional surgery
Study Locations (20)
Delaware
- Delaware Clinical and Laboratory Physicians PA - Newark
- Helen F Graham Cancer Center - Newark
- Medical Oncology Hematology Consultants PA - Newark
- Regional Hematology and Oncology PA - Newark
- Christiana Care Health System-Christiana Hospital - Newark
California
- Cedars Sinai Medical Center - Los Angeles
- Bay Area Tumor Institute - Oakland
- UCSF Medical Center-Mount Zion - San Francisco
Kentucky
- Saint Elizabeth Medical Center South - Edgewood
- Saint Elizabeth Fort Thomas - Fort Thomas
- Baptist Health Lexington - Lexington
Missouri
- Saint Luke's Hospital of Kansas City - Kansas City
- Missouri Baptist Medical Center - St Louis
Colorado
- Exempla Saint Joseph Hospital - Denver
Iowa
- University of Iowa/Holden Comprehensive Cancer Center - Iowa City
Maryland
- Northwest Hospital Center - Randallstown
Massachusetts
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2012-02 |
| Est. Completion | 2018-01 |
| Phase | Phase 2 |
What the finished NCT01439711 record still lists
NCT01439711 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which MRI is the first listed.
NCT01439711 names 20 study sites across 11 states, led by Delaware, California, Kentucky.
Frequently Asked Questions
What is clinical trial NCT01439711 about?
NCT01439711 is a clinical study titled "Letrozole in Treating Postmenopausal Women With Ductal Carcinoma in Situ". RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. PURPOSE: This phase II trial is studying how well letrozole works in trea...
What is the current status of trial NCT01439711?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2012-02. Estimated completion is 2018-01.
What conditions does trial NCT01439711 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT01439711?
The interventions under investigation include: MRI (PROCEDURE), letrozole (DRUG), conventional surgery (PROCEDURE).
Who is sponsoring clinical trial NCT01439711?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01439711 being conducted?
This trial has 20 study locations across California, Colorado, Delaware, Iowa, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01439711's enrollment target sits among peer trials
108 543rd of 1224 higher than 679 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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