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

Sponsors and Collaborators:	H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00090844

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 Cancer-Related Problem/Condition	Drug: triptorelin	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride Triptorelin Triptorelin pamoate Gonadorelin Gonadorelin hydrochloride LH-RH

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control
Official Title:	Preservation of Ovarian Function in Young Women Treated With (Neo) Adjuvant Chemotherapy for Breast Cancer: A Randomized Trial Using the GnRH Agonist (Triptorelin) During Chemotherapy

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 as assessed by record of menses monthly during treatment
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
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
Disease-free survival every very 6 months beginning in month 6 for 2 years and then annually for 3 years

Estimated Enrollment:	138
Study Start Date:	July 2004
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

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 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

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

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
- Clomiphen 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

Contacts and Locations

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

H. Lee Moffitt Cancer Center and Research Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Pamela N. Munster, MD

H. Lee Moffitt Cancer Center and Research Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000374991, MCC-0203, NCI-7031
Study First Received:	September 7, 2004
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00090844
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

drug/agent toxicity by tissue/organ
hormonal changes
stage I breast cancer
stage II breast cancer

Study placed in the following topic categories:

Naphazoline
Deslorelin
Oxymetazoline
Skin Diseases
Guaifenesin

Phenylephrine
Triptorelin
Breast Neoplasms
Phenylpropanolamine
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents
Therapeutic Uses

Physiological Effects of Drugs
Contraceptive Agents, Female
Reproductive Control Agents
Luteolytic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009