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A Phase II Study of the Combination of Exemestane and Goserelin in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

A Phase II Study of the Combination of Exemestane and Goserelin in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer

OBJECTIVES: I. Determine the efficacy of exemestane and goserelin in premenopausal women
with hormone receptor positive metastatic breast cancer after tamoxifen failure. II.
Determine the toxicity of this regimen in these patients. III. Determine the hormonal
profile of patients treated with this regimen. IV. Determine the predictive value of HER-2,
epidermal growth factor receptor, and estrogen receptor for response in patients treated
with this regimen.

OUTLINE: Patients receive oral exemestane daily on days 1-28 and goserelin subcutaneously on
day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable

PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic breast
cancer that has failed prior tamoxifen therapy Measurable disease No CNS metastases
Hormone receptor status: Estrogen or progesterone receptor positive At least 10 fmol/L by
biochemical assay OR At least 10% of cells positive by immunochemistry

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Premenopausal
defined as estradiol at least 30 pg/mL, follicle stimulating hormone less than 25 mIU/mL,
and luteinizing hormone less than 15 mIU/mL Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count
at least 50,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL AST no greater than 3
times normal Renal: Stable renal function Pulmonary: No pulmonary embolism Other: Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
non-hormonal contraception during and for 12 weeks after study No other prior malignancy
except nonmelanoma skin cancer or carcinoma in situ of the cervix No known
hypersensitivity to luteinizing hormone releasing hormone (LHRH), LHRH agonist analogues,
or any of the components of goserelin

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 2
prior chemotherapy regimens Endocrine therapy: See Disease Characteristics No prior
hormonal therapy for metastatic breast cancer No concurrent estrogen (hormone replacement)
therapy No other concurrent hormonal agents for breast cancer (e.g., tamoxifen,
anastrozole, letrozole, aminoglutethimide, or megestrol) No concurrent corticosteroids for
breast cancer unless already receiving such therapy at study entry Radiotherapy: Not
specified Surgery: Not specified Other: Concurrent bisphosphonates allowed for bone
disease provided measurable disease in non-osseous sites No concurrent anticoagulant

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Anne Hamilton, MD, FRACP

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine


United States: Federal Government

Study ID:




Start Date:

June 2000

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms



NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016