Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer

• Status: Completed
• Trial end date: 2018-07-02
• Target enrollment: 0
• Participant gender: Female

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 breast cancer by blocking the use of estrogen by the tumor cells. Given the lack of clinical data on fulvestrant in patients with large operable or locally advanced hormone-receptor-positive breast cancer, and the potential to identify differences in the mechanism of resistance using the neoadjuvant model,we decided to perform a multicentre randomised phase II clinical trial of anastrozole and fulvestrant.

PURPOSE: The aim of this study was to assess the efficacy of neoadjuvant anastrozole and fulvestrant treatment of large operable or locally advanced hormone-receptor-positive breast cancer not eligible for initial breast-conserving surgery, and to identify genomic changes occurring after treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Bergonié
• Collaborator: National Cancer Institute, France
• Treatments: Anastrozole; Estradiol; Estrogens; Fulvestrant

Criteria

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