RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as triptorelin, may protect normal ovarian cells from the side effects of chemotherapy.

PURPOSE: This randomized phase II trial is studying how well triptorelin works in preserving ovarian function in premenopausal women who are receiving chemotherapy for early-stage breast cancer.

Condition	Treatment or Intervention	Phase
Drug Toxicity hormonal changes stage I breast cancer stage II breast cancer	Drug: triptorelin  Procedure: chemoprotection  Procedure: complications of therapy assessment/management  Procedure: endocrine therapy  Procedure: hormone therapy  Procedure: releasing factor agonist therapy  Procedure: supportive care/therapy	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine the protective effect of chemical ovarian suppression using triptorelin on the preservation of ovarian function in premenopausal women with early-stage operable breast cancer undergoing adjuvant or neoadjuvant systemic chemotherapy.

Secondary

• Determine the rate of chemotherapy-related amenorrhea in patients treated with this drug.
• Determine the value of inhibin A and B as alternative markers of premature ovarian failure in patients treated with this drug.
• Determine quality of life of patients treated with this drug.
• Determine disease-free and overall survival of patients treated with this drug.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (< 35 years vs 35 to 39 years vs > 39 years); concurrent neoadjuvant or adjuvant systemic chemotherapy (fluorouracil, epirubicin, and cyclophosphamide [6 courses] OR fluorouracil, doxorubicin, and cyclophosphamide [6 courses] vs doxorubicin and cyclophosphamide [AC] [4 courses] vs AC [4 courses] followed by a taxane [4 courses]); and hormone receptor status (estrogen receptor [ER]- AND progesterone receptor [PR]-negative vs ER- OR PR-positive).

• Arm I: Beginning within 1-4 weeks before the start of chemotherapy, patients receive triptorelin intramuscularly once monthly for 4-6 months during neoadjuvant or adjuvant systemic chemotherapy.
• Arm II: Patients receive neoadjuvant or adjuvant systemic chemotherapy only. Quality of life is assessed at baseline, monthly during treatment, every 6 months for 2 years, and then annually for 3 years.

Patients are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 138 patients (69 per treatment arm) will be accrued for this study within 35 months.

Ages Eligible for Study:  up to  44 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer
• Early-stage, operable disease
• Scheduled to receive adjuvant or neoadjuvant systemic chemotherapy for breast cancer
• Hormone receptor status:
• Meets 1 of the following criteria:
• Estrogen receptor (ER)- OR progesterone receptor (PR)-positive
• ER- AND PR-negative
• No history of premature ovarian failure

PATIENT CHARACTERISTICS: Age

• Under 45

Sex

• Female

Menopausal status

• Premenopausal
• Follicle-stimulating hormone levels < 40 IU/L at baseline AND at least 2 menstrual periods within the past 6 months
• No first-degree relative menopausal at < 40 years of age

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing
• Fertile patients must use effective non-hormonal methods of contraception
• No prior osteoporosis or other non-malignant systemic disease that would preclude prolonged follow-up
• No known allergies to gonadotrophin-releasing hormone agonists
• No other cancer except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• No prior chemotherapy

Endocrine therapy

• At least 2 weeks since prior oral contraceptives
• No prior fertility treatment
• Clomiphen or pergonal for polycystic ovarian disease allowed
• No other concurrent oral or transdermal hormonal therapy, including any of the following:
• Estrogen
• Progesterone
• Androgens
• Aromatase inhibitors
• Hormone replacement therapy
• Oral contraceptives

Radiotherapy

• No prior ovarian radiotherapy

Surgery

• No prior bilateral oophorectomy
• No plans for oophorectomy or hysterectomy within the next 2 years

Other

• At least 1 week since prior warfarin

California
      CCOP - Bay Area Tumor Institute, Oakland,  California,  94609-3305,  United States; Recruiting
Florida
      H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa,  Florida,  33612-9497,  United States; Recruiting
Georgia
      MBCCOP-Medical College of Georgia Cancer Center, Augusta,  Georgia,  30912-4000,  United States; Recruiting
Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
      Hulston Cancer Center at Cox Medical Center South, Springfield,  Missouri,  65807,  United States; Recruiting
      St. John's Regional Health Center, Springfield,  Missouri,  65804-2263,  United States; Recruiting
North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States; Recruiting
Washington
      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States; Recruiting

Study chairs or principal investigators

Pamela N. Munster, MD,  Study Chair,  H. Lee Moffitt Cancer Center and Research Institute   

Study ID Numbers:  CDR0000374991; MCC-0203; NCT00090844
Record last reviewed:  March 2005
Last Updated:  March 21, 2005
Record first received:  September 7, 2004
ClinicalTrials.gov Identifier:  NCT00090844
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08