Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
18 Years
49 Years
Female
Breast Cancer, Infertility, Menopausal Symptoms
Trial Information
Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
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 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Rate of premature ovarian failure at 2 years
Outcome Description:
Ovarian failure at two years is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months AND the presence of FSH in the post-menopausal range.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Halle C Moore, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Cleveland Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000327758
NCT ID:
NCT00068601
Start Date:
October 2003
Completion Date:
September 2016
Related Keywords:
- Breast Cancer
- Infertility
- Menopausal Symptoms
- 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
- Breast Neoplasms
- Infertility
- Menopause, Premature
- Primary Ovarian Insufficiency
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