Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer

March 10, 2016 updated by: NYU Langone Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Anne Hamilton, MD, FRACP, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Primary Completion (Actual)

May 1, 2001

Study Registration Dates

First Submitted

February 2, 2001

First Submitted That Met QC Criteria

April 20, 2004

First Posted (Estimate)

April 21, 2004

Study Record Updates

Last Update Posted (Estimate)

March 11, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068431
  • NYU-0004
  • P-UPJOHN-NYU-0004
  • NCI-G00-1906

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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