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

University of South Florida

Status and phase

Terminated

Phase 2

Conditions

Breast Cancer

Hormone Changes

Drug Toxicity

Treatments

Drug: triptorelin

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00090844

MCC-0203 (Other Identifier)

NCI-7031 (Other Identifier)

P30CA076292 (U.S. NIH Grant/Contract)

CDR0000374991

Details and patient eligibility

About

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.

Full 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.

Enrollment

49 patients

Sex

Female

Ages

Under 44 years old

Volunteers

No 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