Bicalutamide in Treating Patients With Metastatic Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00468715
• Other study ID #: 07-022
• Secondary ID: MSKCC-07022
• Status: Completed
• Phase: Phase 2
• Start date: March 23, 2007
• Est. completion date: June 24, 2021

Study information

• Verified date: June 2021
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 24, 2021
• Est. primary completion date: June 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• bicalutamide

Other:
• diagnostic laboratory biomarker analysis

• immunohistochemistry staining method

Locations

Country	Name	City	State
United States	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Duke Cancer Institute	Durham	North Carolina
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Ralph Lauren Center for Cancer Care and Prevention	New York	New York
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California
United States	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	AstraZeneca, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-month Response Rate (Complete Response, Partial Response, and Stable Disease)	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	6 months
Secondary	Count of Participants With Progression-free Survival	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions	1 year
Secondary	Number of Participants Evaluated for Toxicity	Toxicity measured by CTCAE v3.0	1 year

External Links

•   Memorial Sloan Kettering Cancer Center