Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer

• Status: Terminated
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Florida
• Collaborator: National Cancer Institute (NCI)
• Treatments: Triptorelin Pamoate

Criteria

Inclusion 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

• Eastern Cooperative Oncology Group [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

• Clomiphene 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

Exclusion Criteria:

• History of premature ovarian failure

• Over 45 years of age

• First-degree relative menopausal at < 40 years of age

• Pregnant or nursing

• Prior osteoporosis or other non-malignant systemic disease that would preclude prolonged follow-up

• Known allergies to gonadotrophin-releasing hormone agonists

• Other cancer besides nonmelanoma skin cancer

• Prior chemotherapy

• Prior ovarian radiotherapy

• Prior bilateral oophorectomy