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
N/A
44 Years
Female
Breast Cancer, Hormone Changes, Drug Toxicity
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Time to Resumption of Menses
Outcome 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
Outcome Time Frame:
Baseline, end of chemotherapy then 5 years
Safety Issue:
No
Principal Investigator
Pamela N. Munster, MD
Investigator Role:
Study Chair
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Federal Government
Study ID:
CDR0000374991
NCT ID:
NCT00090844
Start Date:
July 2004
Completion Date:
May 2008
Related Keywords:
- Breast Cancer
- Hormone Changes
- Drug Toxicity
- drug/agent toxicity by tissue/organ
- hormone changes
- stage I breast cancer
- stage II breast cancer
- Breast Neoplasms
- Drug Toxicity
Name | Location |
|---|---|
| CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
| MBCCOP - Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3730 |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
| MBCCOP - JHS Hospital of Cook County | Chicago, Illinois 60612 |
