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Sponsors and Collaborators: |
National Surgical Adjuvant Breast and Bowel Project (NSABP) National Cancer Institute (NCI) North Central Cancer Treatment Group Southwest Oncology Group American College of Surgeons |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00053898 |
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Tamoxifen may fight breast cancer by blocking the use of estrogen. Anastrozole may fight breast cancer by decreasing estrogen production. It is not yet known whether anastrozole is more effective than tamoxifen in preventing the recurrence of breast cancer.
PURPOSE: This randomized phase III trial is studying anastrozole to see how well it works compared to tamoxifen in preventing the recurrence of breast cancer in postmenopausal women with ductal carcinoma in situ who are undergoing lumpectomy and radiation therapy.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: anastrozole Drug: tamoxifen citrate Procedure: adjuvant therapy Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | A Clinical Trial Comparing Anastrozole With Tamoxifen in Postmenopausal Patients With Ductal Carcinoma in Situ (DCIS) Undergoing Lumpectomy With Radiation Therapy |
Estimated Enrollment: | 3000 |
Study Start Date: | January 2003 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (under 60 vs 60 and over). Patients are randomized to 1 of 2 treatment arms (arm I and arm II closed to accrual as of 6/15/06).
Beginning within 8 weeks of randomization, all patients also undergo whole breast radiotherapy, unless the patient is enrolled in protocol NSABP-B-39 and randomized to the partial breast irradiation group.
Patients are followed every 6 months for 5 years, and then annually thereafter.
For patients enrolled in the quality of life study, quality of life is assessed at baseline and then every 6 months for 6 years.*
NOTE: *The quality of life study closed to accrual as of 12/28/04.
PROJECTED ACCRUAL: A total of 3,000 patients (1,500 per treatment arm) will be accrued for this study within 5 years (arm I and arm II closed to accrual as of 6/15/06).
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ductal carcinoma in situ (DCIS) of the breast
Must have undergone lumpectomy
More than 1 area of DCIS allowed provided all disease is removed with tumor-free margins
No prior invasive breast cancer or DCIS
No prior or concurrent invasive (including microinvasive) breast cancer
No bilateral malignancy
No positive ipsilateral axillary or intramammary nodes
Hormone receptor status:
Estrogen- or progesterone-receptor positive as determined by immunohistochemistry
PATIENT CHARACTERISTICS:
Age
Sex:
Menopausal status:
Postmenopausal as defined by at least 1 of the following:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Endocrine therapy
No concurrent sex hormone therapy (e.g., estrogen or progesterone replacement therapy, oral contraceptives, androgens, luteinizing hormone releasing hormone analogs, prolactin inhibitors, or antiandrogens)
Radiotherapy
Surgery
Other
No concurrent participation in another clinical trial of therapy for DCIS
Study Chair: | Richard G. Margolese, MD | Jewish General Hospital |
Study Chair: | Laura A. Vallow, MD | Mayo Clinic |
Study Chair: | Kathy S. Albain, MD | Loyola University |
Study Chair: | Pat W. Whitworth, MD | Dan Rudy Cancer Center at Saint Thomas Hospital |
Study ID Numbers: | CDR0000269539, NSABP-B-35, SWOG-NSABP-B-35, NCCTG-NSABP-B-35, ACOSOG-NSABP-B-35 |
Study First Received: | February 5, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00053898 |
Health Authority: | United States: Federal Government |
breast cancer in situ ductal breast carcinoma in situ |
Anastrozole Skin Diseases Citric Acid Breast Neoplasms Tamoxifen Carcinoma Carcinoma, Ductal |
Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial |
Estrogen Antagonists Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors |
Bone Density Conservation Agents Selective Estrogen Receptor Modulators Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Ductal, Lobular, and Medullary Aromatase Inhibitors |