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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

cyclophosphamide

goserelin acetate

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring infertility, menopausal symptoms, stage II breast cancer, stage IIIA breast cancer, stage IA breast cancer, stage IB breast cancer, estrogen receptor-negative breast cancer, progesterone receptor-negative breast cancer

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Chemotherapy

Chemotherapy Plus Goserelin

Arm Description

Patients receive cyclophosphamide-containing chemotherapy alone.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT00068601

First Posted

September 10, 2003

Last Updated

December 19, 2019

Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI), Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, ETOP IBCSG Partners Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00068601

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI), Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, ETOP IBCSG Partners Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Infertility, Menopausal Symptoms

Keywords

infertility, menopausal symptoms, stage II breast cancer, stage IIIA breast cancer, stage IA breast cancer, stage IB breast cancer, estrogen receptor-negative breast cancer, progesterone receptor-negative breast cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

257 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard Chemotherapy

Arm Type

Active Comparator

Arm Description

Patients receive cyclophosphamide-containing chemotherapy alone.

Arm Title

Chemotherapy Plus Goserelin

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

cyclophosphamide

Intervention Description

Part of planned chemotherapy regimen

Intervention Type

Drug

Intervention Name(s)

goserelin acetate

Intervention Description

Given subcutaneously

Primary Outcome Measure Information:

Title

Rate of Premature Ovarian Failure at 2 Years

Description

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.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Rate of Ovarian Dysfunction at 2 Years

Description

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.

Time Frame

2 years

Title

Rate of Ovarian Dysfunction at 1 Year

Description

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.

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

Ovarian Reserve at 1 and 2 Years

Description

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).

Time Frame

1 and 2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials: