Official Title: “Bicalutamide for the Treatment of Androgen Receptor Positive (AR(+)), Estrogen Receptor Negative, Progesterone Receptor Negative (ER(-)/PR(-)) Metastatic Breast Cancer Patients: A Phase II Feasibility Study”

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.

Study Type: Interventional

Study Design: Treatment, Open Label

Study Primary Completion Date: March 2010

OBJECTIVES:

Primary - Determine the 6-month efficacy rate of bicalutamide as first-, second-, or third-line therapy in patients with androgen receptor-positive and estrogen receptor- and progesterone receptor-negative metastatic breast cancer.

Secondary - Determine the 6-month progression-free survival of patients treated with this drug. - Evaluate the safety of this drug in these patients. - Evaluate changes in estradiol, total and free testosterone, and sex-hormone binding globulin in response to androgen blockade in patients treated with this drug. - Evaluate tissue, including cytokeratins 5/6 and 17, SPDEF, ALCAM, ERBB2, FGFR4, and prostate-specific antigen (PSA), using immunohistochemical analysis in patients treated with this drug.

OUTLINE: This is a open-label study.

Patients receive oral bicalutamide once daily for 4 weeks. Treatment repeats every 4 weeks for 6 months in the absence of disease progression or unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue to receive bicalutamide as above at the discretion of the investigator.

Patients undergo blood and tissue sample collection for correlative studies. Samples are analyzed for hormonal levels, including estradiol, total testosterone, free testosterone, and sex-hormone binding globulin, and proteins, including ALCAM, SPEDF, and CK 5/6, by immunohistochemical analysis at baseline, after course 1, and at the end of the study.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.

Intervention(s) in this Clinical Trial

• Drug: bicalutamide
• Procedure: immunohistochemistry staining method
• Procedure: laboratory biomarker analysis

Primary Measures

• 6-month response rate (complete response, partial response, and stable disease) as measured by RECIST criteria
  • Safety Issue?: No

Secondary Measures

• Median progression-free survival
  • Safety Issue?: No
• Safety
  • Safety Issue?: Yes

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast
• Stage IV disease
• 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
• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Memorial Sloan-Kettering Cancer Center

Overall Clinical Trial Officials and Contacts

Clifford A. Hudis, MD Principal Investigator Memorial Sloan-Kettering Cancer Center  

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00468715

Study ID Number: CDR0000542434

ClinicalTrials.gov Identifier: NCT00468715

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database