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

Primary Purpose

Breast Cancer, Hormone Changes, Drug Toxicity

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
triptorelin
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring drug/agent toxicity by tissue/organ, hormone changes, stage I breast cancer, stage II breast cancer

Eligibility Criteria

undefined - 44 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CCOP - Bay Area Tumor Institute
  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
  • MBCCOP - Medical College of Georgia Cancer Center
  • MBCCOP - JHS Hospital of Cook County
  • CCOP - Cancer Research for the Ozarks
  • Hulston Cancer Center at Cox Medical Center South
  • CCOP - MeritCare Hospital
  • CCOP - Scott and White Hospital
  • CCOP - Northwest

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

triptorelin

no triptorelin

Arm Description

GnRH analogue (triptorelin) during chemotherapy

No GnRH analogue (triptorelin) during chemotherapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 7, 2004
Last Updated
January 12, 2021
Sponsor
University of South Florida
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00090844
Brief Title
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Early closure due to low accrual
Study Start Date
July 2004 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Hormone Changes, Drug Toxicity
Keywords
drug/agent toxicity by tissue/organ, hormone changes, stage I breast cancer, stage II breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
triptorelin
Arm Type
Experimental
Arm Description
GnRH analogue (triptorelin) during chemotherapy
Arm Title
no triptorelin
Arm Type
No Intervention
Arm Description
No GnRH analogue (triptorelin) during chemotherapy
Intervention Type
Drug
Intervention Name(s)
triptorelin
Other Intervention Name(s)
Trelstar Depot
Intervention Description
3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection
Primary Outcome Measure Information:
Title
Time to Resumption of Menses
Description
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
Time Frame
Baseline, end of chemotherapy then 5 years
Secondary Outcome Measure Information:
Title
Chemotherapy-related Amenorrhea
Description
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.
Time Frame
Baseline, end of chemotherapy then 5 years

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela N. Munster, MD
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Bay Area Tumor Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94609-3305
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
MBCCOP - Medical College of Georgia Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-4000
Country
United States
Facility Name
MBCCOP - JHS Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Hulston Cancer Center at Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
CCOP - MeritCare Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
CCOP - Northwest
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405-0986
Country
United States

12. IPD Sharing Statement

Links:
URL
https://pubmed.ncbi.nlm.nih.gov/22231041/
Description
Published Results

Learn more about this trial

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

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