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

This study has been terminated.
(Early closure due to low accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00090844
First received: September 7, 2004
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Hormone Changes
Drug Toxicity
Drug: triptorelin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Time to Resumption of Menses [ Time Frame: Baseline, end of chemotherapy then 5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, end of chemotherapy then 5 years ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, end of chemotherapy then 5 years ] [ Designated as safety issue: No ]
    Inhibin A & inhibin B are collected at baseline, end of chemotherapy, then every 6 months for 2 years then annually for 3 more years. Inhibin A & Inhibin B are markers of ovarian failure.

  • 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 [ Time Frame: Baseline, through chemotherapy then 5 years ] [ Designated as safety issue: No ]
    FACT-ES (v4/4a) quality of life validated tool combines 18 item endocrine subscale (ES) with standardized breast cancer quality of life measure. Administered 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 [ Time Frame: 5 years after end of chemotherapy ] [ Designated as safety issue: No ]
    Every 6 months for 2 years then annual for 3 more years. Patients will be seen, laboratory specimens will be drawn. Menses records will be collected and reviewed. Concomitant medications will be updated.


Enrollment: 49
Study Start Date: July 2004
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: triptorelin
GnRH analogue (triptorelin) during chemotherapy
Drug: triptorelin
3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection
Other Name: Trelstar Depot
No Intervention: no triptorelin
No GnRH analogue (triptorelin) during chemotherapy

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.

  Eligibility

Ages Eligible for Study:   up to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090844

Locations
United States, California
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
United States, Georgia
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912-4000
United States, Illinois
MBCCOP - JHS Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
United States, North Dakota
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Washington
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
Sponsors and Collaborators
University of South Florida
Investigators
Study Chair: Pamela N. Munster, MD H. Lee Moffitt Cancer Center and Research Institute
  More Information

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00090844     History of Changes
Other Study ID Numbers: CDR0000374991, P30CA076292, MCC-0203, NCI-7031
Study First Received: September 7, 2004
Results First Received: November 30, 2012
Last Updated: January 23, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by University of South Florida:
drug/agent toxicity by tissue/organ
hormone changes
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Drug Toxicity
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Poisoning
Substance-Related Disorders
Triptorelin
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 28, 2014