Bicalutamide in Treating Patients With Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2021-06-24
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Androgens can cause the growth of breast cancer cells. Antihormone therapy, such as bicalutamide, may stop the adrenal glands from making androgens.

PURPOSE: This phase II trial is studying how well bicalutamide works in treating patients with metastatic breast cancer.

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

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: AstraZeneca; National Cancer Institute (NCI)
• Treatments: Bicalutamide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast

• Stage IV disease

• Measurable or non-measurable disease

• Patients with HER2/neu-positive disease must have received prior trastuzumab (Herceptin®)

• No active brain metastases or leptomeningeal disease

• History of brain metastases allowed provided lesions are stable for at least 3 months as documented by head CT scan or MRI of the brain

• Hormone receptor status:

• Estrogen receptor- and progesterone receptor-negative*

• Androgen receptor-positive* NOTE: *Samples are considered positive if greater than 10% of cell nuclei are immunoreactive

PATIENT CHARACTERISTICS:

• Male or female

• Menopausal status not specified

• ECOG performance status 0-1

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 9 g/dL

• AST and ALT ≤ 2.5 times upper limit of normal (ULN)

• Bilirubin ≤ 1.5 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN (unless bone metastases are present in the absence of liver metastases)

• Creatinine ≤ 1.5 mg/dL

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No serious medical or psychiatric illness

• No serious active infection

• No other malignancy within the past 5 years except nonmelanoma skin cancer

• No hypersensitivity reaction to bicalutamide or any of the tablet's components

PRIOR CONCURRENT THERAPY:

• At least 2 weeks since prior cytotoxic chemotherapy and recovered

• At least 3 weeks since prior investigational drugs

• At least 4 weeks since prior major surgery and recovered

• Prior neoadjuvant or adjuvant chemotherapy allowed

• Any number of chemotherapy regimens are allowed for metastatic disease

• Prior hormonal therapy allowed

• No concurrent chemotherapy, other hormonal therapy, immunotherapy, or biological therapy

• No concurrent trastuzumab (Herceptin®)

• No concurrent enrollment in another clinical trial in which investigational procedures are performed or investigational therapies are administered