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Sponsors and Collaborators: |
International Breast Cancer Study Group National Cancer Institute (NCI) Breast International Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00066703 |
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.
PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: exemestane Drug: tamoxifen citrate Drug: triptorelin Procedure: adjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer |
Estimated Enrollment: | 2639 |
Study Start Date: | August 2003 |
Estimated Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, concurrent adjuvant chemotherapy (yes vs no), and number of positive axillary and/or internal mammary lymph nodes (0 vs 1 or more). Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment continues for 5 years in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 6 months for 2 years, and annually for 3 years.
Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 2,639 patients will be accrued for this study.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Completely resected disease
Prior surgery for primary breast cancer of 1 of the following types:
Tumor confined to the breast and axillary nodes
Axillary lymph node dissection or a negative axillary sentinel node biopsy required
No locally advanced inoperable breast cancer, including any of the following:
Hormone receptor status:
Estrogen and/or progesterone receptor positive
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Premenopausal
Estradiol in the premenopausal range after prior surgery OR meets the following criteria:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, nonbreast carcinoma in situ, contralateral or ipsilateral carcinoma in situ of the breast, or other nonrecurrent invasive nonbreast malignancy, including any of the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent bisphosphonates, except in the following cases:
Study Chair: | Olivia Pagani, MD | Ospedale Beata Vergine |
Study Chair: | Olivia Pagani, MD | Ospedale Beata Vergine |
Study ID Numbers: | CDR0000316458, IBCSG-25-02, BIG-3-02, NABCI-IBCSG-25-02, EU-20347, EUDRACT-2004-000168-28 |
Study First Received: | August 6, 2003 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00066703 |
Health Authority: | Unspecified |
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Skin Diseases Triptorelin Citric Acid Breast Neoplasms |
Exemestane Tamoxifen Breast Diseases |
Estrogen Antagonists Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Contraceptive Agents Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors |
Bone Density Conservation Agents Reproductive Control Agents Luteolytic Agents Selective Estrogen Receptor Modulators Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Aromatase Inhibitors |