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

NCT ID: NCT00090844

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2008-05-31

Brief 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.

Detailed Description

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 doxorubicin and cyclophosphamide [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.

Conditions

Breast Cancer; Hormone Changes; Drug Toxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

triptorelin

GnRH analogue (triptorelin) during chemotherapy

Group Type: EXPERIMENTAL

triptorelin

Intervention Type: DRUG

3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection

no triptorelin

No GnRH analogue (triptorelin) during chemotherapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

triptorelin

3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection

Intervention Type: DRUG

Other Intervention Names

Trelstar Depot

Eligibility 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

• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pamela N. Munster, MD

Role: STUDY_CHAIR

H. Lee Moffitt Cancer Center and Research Institute

Locations

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

Countries

United States

Related Links

https://pubmed.ncbi.nlm.nih.gov/22231041/

Published Results

Other Identifiers

P30CA076292

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCC-0203

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-7031

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000374991

Identifier Type: -

Identifier Source: org_study_id