Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care Completed Under 45 NCI MCC-0203 NCI-7031, NCT00090844, 7031, HLMCC 0203

Objectives

Primary

1. 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

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

Entry 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

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

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

Expected Enrollment

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

Outcomes

Ovarian function as assessed by follicle stimulating hormone (FSH) and record of menses every 6 months beginning in month 6 for 2 years and then annually for 3 years

Chemotherapy-related amenorrhea as assessed by record of menses monthly during treatment
Alternative markers of ovarian failure as assessed by inhibin A and inhibin B every 6 months beginning in month 6 for 2 years and then annually for 3 years
Quality of life as assessed by FACT-ES monthly during treatment, every very 6 months beginning in month 6 for 2 years and then annually for 3 years
Disease-free survival every very 6 months beginning in month 6 for 2 years and then annually for 3 years

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.

Trial Contact Information

Trial Lead Organizations

H. Lee Moffitt Cancer Center CCOP Research Base

Pamela Munster, MD, Protocol chair		Ph: 813-745-8948 Email: Pamela.Munster@moffitt.org

Registry Information
Official Title		Preservation of Ovarian Function in Young Women Treated with (Neo) Adjuvant Chemotherapy for Breast Cancer: A Randomized Trial Using the GnRH Agonist (Triptorelin) During Chemotherapy
Trial Start Date		2004-07-14
Trial Completion Date		2008-05-28
Registered in ClinicalTrials.gov		NCT00090844
Date Submitted to PDQ		2004-06-07
Information Last Verified		2007-01-18
NCI Grant/Contract Number		CA76292