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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00871858 |
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Date of registration:
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27/03/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer
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Scientific title:
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Response to Neoadjuvant Treatment With Anti-aromatase Anastrozole and Anti-estrogen Fulvestrant: a Randomized Phase II Study in Postmenopausal Patients With Hormone-sensitive Nonmetastatic Breast Cancer and an Exploratory Study of Molecular Signatures of Response |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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114 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00871858 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Louis Mauriac, MD |
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Address:
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Telephone:
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33-56-333-258 |
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Email:
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mauriac@bergonie.org |
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Affiliation:
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Name:
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Louis Mauriac, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Bergonié |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer, meeting 1 of the following criteria:
- SBR grade I-II disease (patients < 65 years of age)
- SBR grade I-III disease (patients > 65 years of age)
- T2 (2-5 cm), T3, or T4B, and N0-1 disease
- No metastatic disease
- Breast lesion not amenable to breast-conserving resection
- No inflammatory breast cancer
- No prior breast cancer
- Hormone receptor status:
- Estrogen receptor- and/or progesterone receptor-positive
PATIENT CHARACTERISTICS:
- Postmenopausal
- No other cancer within the past 5 years except for adequately treated skin carcinoma
or carcinoma in situ of the cervix
- No contraindication to anti-hormonal treatment
- No psychological, familial, social, or geographical reasons that would preclude
follow up
PRIOR CONCURRENT THERAPY:
- At least 8 days since prior hormone replacement therapy
- No concurrent anti-vitamin K treatment
Age minimum:
N/A
Age maximum:
84 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: fulvestrant
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Drug: anastrozole
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Primary Outcome(s)
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Tumor response at 6 months of treatment according to RECIST criteria
[Time Frame: No]
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Secondary ID(s)
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CDR0000633329
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INCA-RECF0514
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ZENECA-IB-HORGEN
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EUDRACT-2007-004216-31
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IB-HORGEN
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IB-IB2007-26
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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