Efficacy of Anastrozole and Fulvestrant in Patients With ER Positive, HER2 Negative, Operable Breast Cancer

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: Female

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.

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

Details

• Lead Sponsor: UNICANCER
• Treatments: Anastrozole; Estradiol; Fulvestrant

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed infiltrating breast adenocarcinoma

• Large, operable tumor

• Stage T2 (≥ 3 cm) or T3-T4 (excluding inflammatory disease), N0-N3, M0 disease

• No bilateral inflammatory breast tumors (T4d [PEV-2 or PEV-3])

• Elston-Ellis grade I or II and mitotic index 1 or 2 (if < 65 years of age)

• At least 1 embedded and 1 frozen biopsy sample available

• No multifocal or multicentric tumors for which breast conservation cannot be envisaged

• No ErbB2-overexpressing tumors (HER2 3+ by IHC OR HER2 2+ by IHC and FISH positive)

• Hormone receptor status:

• Estrogen receptor and/or progesterone receptor positive tumor (> 10%) as assessed by IHC

PATIENT CHARACTERISTICS:

• Female

• Postmenopausal

• ECOG performance status 0-2

• ANC ≥ 2,000/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 10 g/dL

• Creatinine ≤ 1.5 times upper limit of normal (ULN)

• Total bilirubin ≤ 1.25 times ULN

• AST and ALT ≤ 1.5 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN

• No other cancer within the past 10 years, except basal cell skin cancer or previously treated carcinoma in situ of the cervix

• No uncontrolled cardiac pathology, including any of the following:

• Angina pectoris

• Congestive cardiac insufficiency

• Myocardial infarction within the past 3 months

• No known history of hemorrhagic diathesis

• No known allergy to the study drugs or their excipients

• No congenital galactosemia, glucose malabsorption syndrome, or lactase deficiency

• No chronic somatic or psychiatric illness with pejorative prognosis

• No geographical, social, or psychiatric condition that would preclude study compliance and follow-up schedule

• No individual deprived of liberty or placed under the authority of a tutor

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy, hormonal therapy, or any targeted treatment for the breast tumor

• At least 2 weeks since prior hormone replacement therapy for menopause

• No concurrent long-term anticoagulation treatment

• No concurrent participation on another therapeutic trial involving an experimental molecule