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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004247 |
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells. Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Raloxifene may be effective in preventing the recurrence of breast cancer.
PURPOSE: Randomized phase II trial to evaluate the effectiveness of exemestane and raloxifene in treating postmenopausal women who have a history of ductal carcinoma in situ, stage I, stage II, or stage III breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: exemestane Drug: raloxifene Procedure: adjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Active Control |
Official Title: | Combined Estrogen Blockade of the Breast With Exemestane and Raloxifene in Estrogen Receptor (ER)-Negative and Progesterone Receptor (PR)-Negative Postmenopausal Women With a History of Breast Cancer Who Have No Clinical Evidence of Disease |
Study Start Date: | April 1999 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
Quality of life is assessed at baseline, and then at 3, 6, and 12 months. Patients who continue treatment after 1 year have quality of life assessed at 24, 36, 48, and 60 months.
Patients are followed every 3 months for the first year. Patients who continue treatment after 1 year are followed every 6 months through the fifth year.
PROJECTED ACCRUAL: A total of 30 patients (15 per arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Stage 0 (ductal carcinoma in situ), I, II, or III breast cancer with no clinical evidence of disease after completion of all planned adjuvant therapy
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Menopausal status:
Postmenopausal, as defined by 1 of the following:
No spontaneous menses for at least 5 years
Sex:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Maura N. Dickler, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000067493, MSKCC-99017, NCI-G99-1662 |
Study First Received: | January 28, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004247 |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer stage IIIA breast cancer breast cancer in situ |
recurrent breast cancer stage IIIB breast cancer stage IIIC breast cancer ductal breast carcinoma in situ |
Progesterone Skin Diseases Breast Neoplasms Recurrence Carcinoma Carcinoma, Ductal Raloxifene |
Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Exemestane Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial |
Estrogen Antagonists Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Enzyme Inhibitors |
Selective Estrogen Receptor Modulators Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Ductal, Lobular, and Medullary Aromatase Inhibitors |