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

Stopped early · Phase 2

Conditions studied: Breast Cancer, Hormone Changes, Drug Toxicity

In brief

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.

Key facts

Study ID

NCT00090844

Run by

University of South Florida

People needed

49

Starts

2004-07-01

Expected to finish

2008-05-01

Last updated by the study team

2021-01-28

Who can join

Age: any, up to 44. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CCOP - Bay Area Tumor Institute — Oakland, California, United States
• H. Lee Moffitt Cancer Center and Research Institute at University of South Florida — Tampa, Florida, United States
• MBCCOP - Medical College of Georgia Cancer Center — Augusta, Georgia, United States
• MBCCOP - JHS Hospital of Cook County — Chicago, Illinois, United States
• CCOP - Cancer Research for the Ozarks — Springfield, Missouri, United States
• Hulston Cancer Center at Cox Medical Center South — Springfield, Missouri, United States
• CCOP - MeritCare Hospital — Fargo, North Dakota, United States
• CCOP - Scott and White Hospital — Temple, Texas, United States
• CCOP - Northwest — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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