Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

September 10, 2003

Last Updated Date

November 5, 2009

Start Date ^ICMJE

October 2003

Estimated Primary Completion Date

January 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Rate of premature ovarian failure at 2 years [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Rate of premature ovarian failure at 2 years

Change History

Complete list of historical versions of study NCT00068601 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Rate of ovarian dysfunction at 1 and 2 years [ Designated as safety issue: No ]
Ovarian reserve at 1 and 2 years [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Rate of ovarian dysfunction at 1 and 2 years
Ovarian reserve at 1 and 2 years

Descriptive Information

Brief Title ^ICMJE

Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer

Official Title ^ICMJE

Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer

Brief Summary

RATIONALE: Goserelin blocks hormone production in the ovaries. It is not yet known whether ovarian suppression using goserelin will prevent ovarian failure (early menopause) in women receiving chemotherapy for breast cancer.

PURPOSE: This randomized phase III trial is studying how well giving goserelin together with chemotherapy works compared with chemotherapy alone in preventing early menopause in women with stage I, stage II, or stage IIIA breast cancer.

Detailed Description

OBJECTIVES:

Primary

Compare the rate of premature ovarian failure in women with stage I-IIIA hormone receptor-negative breast cancer treated with chemotherapy with vs without goserelin.

Secondary

Compare the rate of ovarian dysfunction in patients treated with these regimens.
Compare ovarian reserve in patients treated with these regimens.
Describe the pregnancy rates in patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are stratified according to age (under 40 vs 40 to 49) and planned chemotherapy regimen (3-month/4-course anthracycline-based vs 6- to 8-month/course anthracycline-based vs 6- to 8-month/course non-anthracycline-based). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive cyclophosphamide-containing chemotherapy alone. Patients are followed at 1, 2, and 5 years.

PROJECTED ACCRUAL: A total of 416 patients (208 per treatment arm) will be accrued for this study within 3 years.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Randomized, Active Control

Condition ^ICMJE

Breast Cancer
Menopausal Symptoms
Sexual Dysfunction and Infertility

Intervention ^ICMJE

Drug: cyclophosphamide
Drug: goserelin

Study Arms / Comparison Groups

Experimental: Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.
Active Comparator: Patients receive cyclophosphamide-containing chemotherapy alone.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

416

Completion Date

Estimated Primary Completion Date

January 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Histologically confirmed invasive breast cancer
- Stage I-IIIA
- Operable disease
Bilateral synchronous invasive breast cancer allowed provided primary tumors were diagnosed no more than 1 month apart and both tumors are hormone receptor negative
Must be planning to receive 3-8 months of a preoperative or postoperative chemotherapy regimen containing alkylating agents (anthracyclines or non-anthracyclines), meeting 1 of the following criteria:
- 3-month/4-course anthracycline-based regimen
- 6- to 8-month/course anthracycline-based regimen
- 6- to 8-month/course non-anthracycline-based regimen
Hormone receptor status:
- Estrogen receptor negative
- Progesterone receptor negative

PATIENT CHARACTERISTICS:

Age

18 to 49

Sex

Female

Menopausal status

Premenopausal

Performance status

Zubrod 0-2

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Not pregnant or nursing
Fertile patients must use effective barrier contraception
No other prior malignancy except adequately treated basal cell or squamous cell skin cancer or any in situ cancer from which the patient has been disease-free for at least 5 years after treatment with curative intent

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics
No prior cytotoxic chemotherapy

Endocrine therapy

No other concurrent hormonal therapy

Radiotherapy

Concurrent radiotherapy to the breast, chest wall, or lymph nodes allowed

Surgery

See Disease Characteristics

Other

Concurrent participation in other therapeutic clinical trials, including SWOG-S0221, allowed

Gender

Female

Ages

18 Years to 49 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States, Australia, Belgium, Hungary, Italy, New Zealand, Peru, Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00068601

Responsible Party

Laurence H. Baker, University of Michigan Comprehensive Cancer Center

Study ID Numbers ^ICMJE

CDR0000327758, SWOG-S0230, CALGB-40401, ECOG-S0230, IBCSG-34-05, EUDRACT-2006-002600-33, EU-20632

Study Sponsor ^ICMJE

Southwest Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
International Breast Cancer Study Group

Investigators ^ICMJE

Investigator:	Halle C.F. Moore, MD	The Cleveland Clinic
Investigator:	Kathy S. Albain, MD	Loyola University
Investigator:	Silvana Martino, DO	John Wayne Cancer Institute at Saint John's Health Center
Study Chair:	Ann H. Partridge, MD, MPH	Dana-Farber Cancer Institute
Study Chair:	Lori J. Goldstein, MD	Fox Chase Cancer Center
Study Chair:	Kelly-Anne Phillips	Peter MacCallum Cancer Centre, Australia

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP