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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

September 7, 2004
January 23, 2013
July 2004
May 2008   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00090844 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Breast Cancer
  • Hormone Changes
  • Drug Toxicity
Drug: triptorelin
3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection
Other Name: Trelstar Depot
  • Experimental: triptorelin
    GnRH analogue (triptorelin) during chemotherapy
    Intervention: Drug: triptorelin
  • No Intervention: no triptorelin
    No GnRH analogue (triptorelin) during chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
49
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Female
up to 44 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00090844
CDR0000374991, P30CA076292, MCC-0203, NCI-7031
Yes
University of South Florida
University of South Florida
National Cancer Institute (NCI)
Study Chair: Pamela N. Munster, MD H. Lee Moffitt Cancer Center and Research Institute
University of South Florida
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP