S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer

Phase 3

Completed

• Conditions: Breast Cancer; Menopausal Symptoms; Infertility
• Interventions: Drug: cyclophosphamide; Drug: goserelin acetate

• Registration Number: NCT00068601
• Lead Sponsor: SWOG Cancer Research Network

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- to 4-month/course anthracycline-based vs 6- to 8-month/course anthracycline-based vs 3- to 4-month/course non-anthracycline-based vs 6- to 8-month/course non-anthracycline-based). Patients are randomized to 1 of 2 treatment arms.

* Arm 1: Patients receive cyclophosphamide-containing chemotherapy alone. Patients are followed at 1, 2, and 5 years.

* Arm 2: 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.

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

Study Timeline

• Study First Submitted: 2003-09-10
• Study First Submitted QC: 2003-09-10
• Study First Posted: 2003-09-11
• Study Start: 2003-10
• Primary Completion: 2014-01
• Study Completion: 2016-09
• Results First Submitted: 2016-12-16
• Results First Submitted QC: 2017-02-15
• Results First Posted: 2017-04-04
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-19
• Last Update Posted: 2019-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 257

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy Plus Goserelin	cyclophosphamide	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.
Chemotherapy Plus Goserelin	goserelin acetate	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.
Standard Chemotherapy	cyclophosphamide	Patients receive cyclophosphamide-containing chemotherapy alone.

Primary Outcome Measures

Name	Time	Method
Rate of Premature Ovarian Failure at 2 Years	2 years	Ovarian failure at two years is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months AND the presence of follicle-stimulating hormone (FSH) in the post-menopausal range.

Secondary Outcome Measures

Name	Time	Method
Rate of Ovarian Dysfunction at 1 Year	1 year	Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.
Rate of Ovarian Dysfunction at 2 Years	2 years	Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.

Trial Locations

Locations (34)

Mater Hospital - North Sydney; 🇦🇺 North Sydney, New South Wales, Australia

Royal North Shore Hospital; 🇦🇺 St. Leonards, New South Wales, Australia

Newcastle Mater Misericordiae Hospital; 🇦🇺 Waratah, New South Wales, Australia

Royal Adelaide Hospital Cancer Centre; 🇦🇺 Adelaide, South Australia, Australia

Flinders Medical Centre; 🇦🇺 Bedford Park, South Australia, Australia

Royal Hobart Hospital; 🇦🇺 Hobart, Tasmania, Australia

Ballarat Oncology and Haematology Services; 🇦🇺 Ballarat, Victoria, Australia

Box Hill Hospital; 🇦🇺 Box Hill, Victoria, Australia

Monash Medical Center - Clayton Campus; 🇦🇺 Clayton, Victoria, Australia

Peter MacCallum Cancer Centre; 🇦🇺 East Melbourne, Victoria, Australia

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