Bicalutamide in Treating Patients With Metastatic Breast Cancer - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00468715

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: bicalutamide Other: immunohistochemistry staining method Other: laboratory biomarker analysis	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Bicalutamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

6-month response rate (complete response, partial response, and stable disease) as measured by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:

Median progression-free survival [ Designated as safety issue: No ]
Safety [ Designated as safety issue: Yes ]

Estimated Enrollment:	28
Study Start Date:	March 2007
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468715

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Clifford A. Hudis, MD 646-888-4551
Ralph Lauren Center for Cancer Care and Prevention	Recruiting
New York, New York, United States, 10035
Contact: Joseph P. Yoe, MD 212-987-1777

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Clifford A. Hudis )
Study ID Numbers:	CDR0000542434, MSKCC-07022
Study First Received:	May 2, 2007
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00468715 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IV breast cancer
recurrent breast cancer
male breast cancer

Study placed in the following topic categories:

Estrogens
Skin Diseases
Progesterone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Breast Cancer, Male

Hormones
Recurrence
Androgen Antagonists
Breast Neoplasms, Male
Bicalutamide
Breast Diseases
Androgens

Additional relevant MeSH terms:

Skin Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Pharmacologic Actions

Neoplasms
Androgen Antagonists
Neoplasms by Site
Therapeutic Uses
Bicalutamide
Breast Diseases

ClinicalTrials.gov processed this record on May 06, 2009