NCT00010010

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2001

Completed
3 years until next milestone

First Posted

Study publicly available on registry

April 21, 2004

Completed
Last Updated

March 11, 2016

Status Verified

March 1, 2016

Enrollment Period

11 months

First QC Date

February 2, 2001

Last Update Submit

March 10, 2016

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Interventions

exemestaneDRUG
goserelin acetateDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestaneGoserelin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Anne Hamilton, MD, FRACP

    NYU Langone Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2001

First Posted

April 21, 2004

Study Start

June 1, 2000

Primary Completion

May 1, 2001

Last Updated

March 11, 2016

Record last verified: 2016-03

Locations

US(1)