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

Breast Cancer Clinical Trial

Official title:

Preservation of Ovarian Function in Young Women Treated With (Neo) Adjuvant Chemotherapy for Breast Cancer: A Randomized Trial Using the Gonadotropin-releasing Hormone (GnRH) Agonist (Triptorelin) During Chemotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00090844
• Other study ID #: CDR0000374991
• Secondary ID: P30CA076292MCC-0
• Status: Terminated
• Phase: Phase 2
• Start date: July 2004
• Est. completion date: May 2008

Study information

• Verified date: January 2013
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Drug Toxicity
• Drug-Related Side Effects and Adverse Reactions
• Hormone Changes

Intervention

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

Locations

Country	Name	City	State
United States	MBCCOP - Medical College of Georgia Cancer Center	Augusta	Georgia
United States	MBCCOP - JHS Hospital of Cook County	Chicago	Illinois
United States	CCOP - MeritCare Hospital	Fargo	North Dakota
United States	CCOP - Bay Area Tumor Institute	Oakland	California
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 - Northwest	Tacoma	Washington
United States	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida	Tampa	Florida
United States	CCOP - Scott and White Hospital	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Resumption of Menses	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	Baseline, end of chemotherapy then 5 years
Secondary	Chemotherapy-related Amenorrhea	Chemotherapy-related amenorrhea as assessed by record of menses monthly during treatment. Record of menses is completed by patient throughout their time on study through chemotherapy and for 5 years.	Baseline, end of chemotherapy then 5 years

External Links

•   Published Results