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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00217659 |
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using goserelin and anastrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving goserelin together with anastrozole may be an effective treatment for male breast cancer.
PURPOSE: This phase II trial is studying how well giving goserelin together with anastrozole works in treating men with recurrent or metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: anastrozole Drug: goserelin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Goserelin Plus Anastrozole for the Treatment of Male Patients With Hormone-Receptor Positive Metastatic or Recurrent Breast Cancer |
Estimated Enrollment: | 56 |
Study Start Date: | September 2005 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive goserelin subcutaneously on day 1 and oral anastrozole on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at approximately 4-6 weeks and then every 3-6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study within 48 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed breast cancer
Recurrent or metastatic (stage IV) disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
Able to receive oral medication
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Investigator: | Zeina Nahleh, MD | Barrett Cancer Center |
Investigator: | Abdul-Rahman Jazieh, MD, MPH | Barrett Cancer Center |
Investigator: | Robert B. Livingston, MD | University of Washington |
Investigator: | Gabriel N. Hortobagyi, MD, FACP | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000442919, SWOG-S0511 |
Study First Received: | September 20, 2005 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00217659 |
Health Authority: | United States: Federal Government |
male breast cancer recurrent breast cancer stage IV breast cancer |
Anastrozole Skin Diseases Breast Neoplasms, Male Goserelin |
Breast Neoplasms Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Aromatase Inhibitors Pharmacologic Actions |