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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00068601
• Other study ID #: CDR0000327758
• Secondary ID: S0230CALGB-40401
• Status: Completed
• Phase: Phase 3
• Start date: October 2003
• Est. completion date: September 2016

Study information

• Verified date: December 2019
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00696267

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: September 2016
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Infertility
• Menopausal Symptoms

Intervention

Drug:
• cyclophosphamide
Part of planned chemotherapy regimen
• goserelin acetate
Given subcutaneously

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital Cancer Centre	Adelaide	South Australia
Australia	Ballarat Oncology and Haematology Services	Ballarat	Victoria
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Monash Medical Center - Clayton Campus	Clayton	Victoria
Australia	Peter MacCallum Cancer Centre	East Melbourne	Victoria
Australia	Maroondah Hospital	East Ringwood	Victoria
Australia	St. Vincent's Hospital - Melbourne	Fitzroy	Victoria
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Mater Hospital - North Sydney	North Sydney	New South Wales
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Royal North Shore Hospital	St. Leonards	New South Wales
Australia	Newcastle Mater Misericordiae Hospital	Waratah	New South Wales
Belgium	Centre Hospitalier Hutois	Huy
Belgium	U.Z. Gasthuisberg	Leuven
Belgium	Centre Hospitalier Regional de la Citadelle	Liege
Belgium	CHU Liege - Domaine Universitaire du Sart Tilman	Liege
Belgium	AZ Damiaan	Oostende
Belgium	Centre Hospitalier Peltzer-La Tourelle	Verviers
Hungary	National Institute of Oncology	Budapest
Italy	Ospedali Riuniti di Bergamo	Bergamo
Italy	Ospedale degli Infermi - ASL 12	Biella
Italy	Ospedale Civile Ramazzini	Carpi
Italy	Ospedale Alessandro Manzoni	Lecco
Italy	European Institute of Oncology	Milano
New Zealand	Auckland City Hospital	Auckland
Switzerland	Oncology Institute of Southern Switzerland	Bellinzona
Switzerland	Inselspital Bern	Bern
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Oncology Institute of Southern Switzerland - Locarno	Locarno
Switzerland	Oncology Institute of Southern Switzerland - Lugano	Lugano
Switzerland	Oncology Institute of Southern Switzerland - Mendrisio	Mendrisio
Switzerland	Regionalspital	Thun

Sponsors (5)

Lead Sponsor	Collaborator
Southwest Oncology Group	Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, International Breast Cancer Study Group, National Cancer Institute (NCI)

Countries where clinical trial is conducted

Australia,  Belgium,  Hungary,  Italy,  New Zealand,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ovarian Reserve at 1 and 2 Years	Measurements of ovarian reserve will consist of "Day 2 - 4" levels of FSH, estradiol and inhibin B during Month 12/13 and Month 24/25 (or if amenorrheic, anytime during Month 12/13 and Month 24/25).	1 and 2 years
Primary	Rate of Premature Ovarian Failure at 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.	2 years
Secondary	Rate of Ovarian Dysfunction at 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.	2 years
Secondary	Rate of Ovarian Dysfunction at 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.	1 year

External Links

•   Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.