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Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00010010
First received: February 2, 2001
Last updated: November 8, 2012
Last verified: August 2001
  Purpose

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane plus goserelin may fight breast cancer by reducing the production of estrogen.

PURPOSE: Phase II trial to study the effectiveness of exemestane and goserelin in treating premenopausal women who have metastatic breast cancer that has not responded to previous tamoxifen.


Condition Intervention Phase
Breast Cancer
Drug: exemestane
Drug: goserelin acetate
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of the Combination of Exemestane and Goserelin in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Study Start Date: June 2000
Primary Completion Date: May 2001 (Final data collection date for primary outcome measure)
Detailed Description:

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 toxicity.

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

  Eligibility

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010010

Locations
United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Study Chair: Anne Hamilton, MD, FRACP New York University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00010010     History of Changes
Other Study ID Numbers: CDR0000068431, NYU-0004, P-UPJOHN-NYU-0004, NCI-G00-1906
Study First Received: February 2, 2001
Last Updated: November 8, 2012
Health Authority: United States: Federal Government

Keywords provided by New York University School of Medicine:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Exemestane
Goserelin
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014