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Sponsors and Collaborators: |
National Surgical Adjuvant Breast and Bowel Project (NSABP) National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00016432 |
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen by the tumor cells. It is not yet known whether exemestane is effective in preventing the recurrence of breast cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of exemestane in preventing cancer recurrence in postmenopausal women who have resected stage I, stage II, or stage IIIA breast cancer and have completed 5 years of tamoxifen.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: exemestane |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Trial Evaluating The Effect Of Exemestane In Clinical Stage T1-3 N0-1 M0 Postmenopausal Breast Cancer Patients Completing At Least Five Years Of Tamoxifen Therapy |
Study Start Date: | May 2001 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline and then every 6 months for 5.5 years.
Patients are followed every 6 months for 6 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study within 3 years and 4 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive adenocarcinoma of the breast at time of original diagnosis
Prior surgical resection, including 1 of the following:
Lumpectomy and axillary dissection
Prior sentinel node biopsy allowed with the exception of the following:
Previously treated with tamoxifen for 57-66 months
No advanced disease at time of original diagnosis (e.g., ulceration, erythema, infiltration of the skin or underlying chest wall [complete fixation], peau d'orange, or skin edema of any magnitude)
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Postmenopausal, defined as 1 of the following:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
No concurrent estrogen, progesterone, clomiphene, testosterone, gonadotropin-releasing hormone, oral contraceptives, selective estrogen-receptor modulators, or dehydroepiandrosterone (DHEA)
Radiotherapy:
Surgery:
Other:
Study Chair: | Terry Mamounas, MD, MPH, FACS | Aultman Cancer Center at Aultman Hospital |
Study ID Numbers: | CDR0000068640, NSABP-B-33, ECOG-NSABP-B-33 |
Study First Received: | May 6, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00016432 |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Skin Diseases Breast Neoplasms Exemestane Tamoxifen Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Aromatase Inhibitors Pharmacologic Actions |