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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00090844 |
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 |
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 |
Estimated Enrollment: | 138 |
Study Start Date: | July 2004 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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).
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.
Ages Eligible for Study: | up to 44 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Hormone receptor status:
Meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Premenopausal
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No prior fertility treatment
No other concurrent oral or transdermal hormonal therapy, including any of the following:
Radiotherapy
Surgery
Other
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 |
Study Chair: | Pamela N. Munster, MD | H. Lee Moffitt Cancer Center and Research Institute |
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 |
drug/agent toxicity by tissue/organ hormonal changes stage I breast cancer stage II breast cancer |
Naphazoline Deslorelin Oxymetazoline Skin Diseases Guaifenesin |
Phenylephrine Triptorelin Breast Neoplasms Phenylpropanolamine Breast Diseases |
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 |