Clinical trial NCT00468715: Bicalutamide in Treating Patients With Metastatic Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage IV breast cancer
recurrent breast cancer
male breast cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: AstraZeneca
First posted: 2007-05-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: 6-month Response Rate (Complete Response, Partial Response, and Stable Disease)
timeFrame: 6 months
Secondary outcomes:
measure: Count of Participants With Progression-free Survival
timeFrame: 1 year
measure: Number of Participants Evaluated for Toxicity
timeFrame: 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: Washington
country: United States
facility: Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
state: District of Columbia
city: Boston
country: United States
facility: Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: New York
country: United States
facility: Ralph Lauren Center for Cancer Care and Prevention
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Tiffany A. Traina, MD
role: PRINCIPAL_INVESTIGATOR
References: