Status:
COMPLETED
Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer
Lead Sponsor:
Institut Bergonié
Collaborating Sponsors:
National Cancer Institute, France
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-100 years
Phase:
PHASE2
Brief Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes. Fulvestrant may fight brea...
Detailed Description
OBJECTIVES: Primary * Evaluate clinical tumor response at 6 months in patients with hormone-sensitive non-metastatic breast cancer treated with neoadjuvant anastrozole and fulvestrant. Secondary *...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 18 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00871858
Start Date
March 18 2008
End Date
July 2 2018
Last Update
February 24 2021
Active Locations (1)
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1
Institut Bergonie
Bordeaux, France, 33076