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Bicalutamide in Treating Patients With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00468715
Recruitment Status : Active, not recruiting
First Posted : May 3, 2007
Last Update Posted : April 5, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
AstraZeneca
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE May 2, 2007
First Posted Date  ICMJE May 3, 2007
Last Update Posted Date April 5, 2019
Actual Study Start Date  ICMJE March 2007
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2012)
  • 6-month response rate (complete response, partial response, and stable disease) as measured by RECIST criteria for patients with measurable disease [ Time Frame: 6 months ]
  • 6-month response rate (stable disease or progressive disease) as measured by RECIST criteria for patients with non-measurable disease [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2007)
6-month response rate (complete response, partial response, and stable disease) as measured by RECIST criteria
Change History Complete list of historical versions of study NCT00468715 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2012)
  • Median progression-free survival [ Time Frame: 1 year ]
  • Safety [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2007)
  • Median progression-free survival
  • Safety
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bicalutamide in Treating Patients With Metastatic Breast Cancer
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: bicalutamide
  • Other: diagnostic laboratory biomarker analysis
  • Other: immunohistochemistry staining method
Study Arms  ICMJE Experimental: bicalutamide
This is a multicenter, open-label, phase II study to evaluate the antitumor activity and safety of bicalutamide administered orally daily to patients with ER(-)/PR(-)/AR(+) metastatic breast cancer. Eligible patients who have consented to trial participation will receive bicalutamide at a dose of 150mg PO daily.
Interventions:
  • Drug: bicalutamide
  • Other: diagnostic laboratory biomarker analysis
  • Other: immunohistochemistry staining method
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2007)
28
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00468715
Other Study ID Numbers  ICMJE 07-022
MSKCC-07022
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • AstraZeneca
Investigators  ICMJE
Principal Investigator: Tiffany A. Traina, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP