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

Sponsor:	Southwest Oncology Group
Collaborators:	National Cancer Institute (NCI) Cancer and Leukemia Group B Eastern Cooperative Oncology Group International Breast Cancer Study Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00068601

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Menopausal Symptoms Sexual Dysfunction and Infertility	Drug: cyclophosphamide Drug: goserelin	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control
Official Title:	Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Infertility Menopause Premature Ovarian Failure

Drug Information available for: Cyclophosphamide Goserelin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	416
Study Start Date:	October 2003
Estimated Primary Completion Date:	January 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: 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.	Drug: cyclophosphamide Part of planned chemotherapy regimen Drug: goserelin Given subcutaneously
Arm II: Active Comparator Patients receive cyclophosphamide-containing chemotherapy alone.	Drug: cyclophosphamide Part of planned chemotherapy regimen

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.

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068601

Show 217 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Cancer and Leukemia Group B

Eastern Cooperative Oncology Group

International Breast Cancer Study Group

Investigators

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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Michigan Comprehensive Cancer Center ( Laurence H. Baker )
Study ID Numbers:	CDR0000327758, SWOG-S0230, CALGB-40401, ECOG-S0230, IBCSG-34-05, EUDRACT-2006-002600-33, EU-20632
Study First Received:	September 10, 2003
Last Updated:	November 21, 2009
ClinicalTrials.gov Identifier:	NCT00068601 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

sexual dysfunction and infertility
menopausal symptoms
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:

Infertility
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Ovarian Diseases
Cyclophosphamide
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Alkylating Agents
Breast Diseases
Antineoplastic Agents, Hormonal

Skin Diseases
Goserelin
Endocrine System Diseases
Breast Neoplasms
Ovarian Failure, Premature
Genital Diseases, Male
Immunosuppressive Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 27, 2009