Efficacy of Anastrozole and Fulvestrant in Patients With ER Positive, HER2 Negative, Operable Breast Cancer (NIMFEA)
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ClinicalTrials.gov Identifier: NCT00629616 |
Recruitment Status
: Unknown
Verified August 2014 by UNICANCER.
Recruitment status was: Active, not recruiting
First Posted
: March 6, 2008
Last Update Posted
: August 6, 2014
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Tracking Information | ||||
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First Submitted Date ICMJE | March 5, 2008 | |||
First Posted Date ICMJE | March 6, 2008 | |||
Last Update Posted Date | August 6, 2014 | |||
Study Start Date ICMJE | August 2007 | |||
Estimated Primary Completion Date | September 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Clinical tumor response as assessed by RECIST criteria [ Time Frame: 6 months ] | |||
Original Primary Outcome Measures ICMJE |
Clinical tumor response at 6 months as assessed by RECIST criteria | |||
Change History | Complete list of historical versions of study NCT00629616 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Efficacy of Anastrozole and Fulvestrant in Patients With ER Positive, HER2 Negative, Operable Breast Cancer | |||
Official Title ICMJE | A Randomized Multicenter Phase II Study Identifying Hormone Sensitivity Profiles and Evaluating the Efficacy of Anastrozole and Fulvestrant in the Neo-adjuvant Treatment of Operable Breast Cancer in Postmenopausal Women. | |||
Brief Summary | RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole or fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes or by blocking the use of estrogen by the tumor cells. Giving hormone therapy before surgery may be an effective treatment for breast cancer. It is not yet known whether anastrozole is more effective than fulvestrant when given before surgery in treating women with breast cancer. PURPOSE: This randomized phase II trial is studying anastrozole to see how well it works compared with fulvestrant in treating postmenopausal women with stage II or stage III breast cancer that can be removed by surgery. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
Patients in both arms then undergo surgery and radiotherapy according to institutional guidelines. Patients then receive adjuvant hormonal therapy for at least 5 years. After completion of study therapy, patients are followed periodically for up to 3 years. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Actual Enrollment ICMJE |
116 | |||
Original Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date | September 2016 | |||
Estimated Primary Completion Date | September 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Sex/Gender |
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Ages | Child, Adult, Senior | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00629616 | |||
Other Study ID Numbers ICMJE | CARMINA02 CARMINA-02/0609 ( Other Identifier: UNICANCER ) 2006-006409-10 ( EudraCT Number ) NIMFEA ( Other Identifier: UNICANCER ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | UNICANCER | |||
Study Sponsor ICMJE | UNICANCER | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | UNICANCER | |||
Verification Date | August 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |