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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) Cancer and Leukemia Group B NCIC Clinical Trials Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003857 |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if radiation therapy is more effective than observation, with or without tamoxifen, in treating ductal carcinoma in situ.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of observation, with or without tamoxifen, in treating women who have ductal carcinoma in situ.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: tamoxifen citrate Procedure: adjuvant therapy Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus RT for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast |
Estimated Enrollment: | 1790 |
Study Start Date: | December 1999 |
Estimated Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), final path margins (negative vs 3-9 mm vs at least 10 mm), mammographic size of primary (no greater than 1 cm vs greater than 1 cm to 2.5 cm), nuclei grade (low vs intermediate), and tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,790 patients will be accrued for this study within 6 years.
Ages Eligible for Study: | 26 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Ductal carcinoma in situ (DCIS) of the breast detected by mammogram at the time of diagnosis
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Beryl McCormick, MD | Memorial Sloan-Kettering Cancer Center |
Investigator: | Clifford A. Hudis, MD | Memorial Sloan-Kettering Cancer Center |
Study Chair: | Barbara L. Smith, MD, PhD | Massachusetts General Hospital |
Study Chair: | Timothy J. Whelan, MD | Margaret and Charles Juravinski Cancer Centre |
Investigator: | Eileen Rakovitch, MD | Edmond Odette Cancer Centre at Sunnybrook |
Study ID Numbers: | CDR0000067020, RTOG-9804, CAN-NCIC-MA26, CALGB-49801, RTOG-DEV-1026 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003857 History of Changes |
Health Authority: | United States: Federal Government |
breast cancer in situ ductal breast carcinoma in situ |
Estrogen Antagonists Estrogens Antineoplastic Agents, Hormonal Skin Diseases Hormone Antagonists Citric Acid Hormones, Hormone Substitutes, and Hormone Antagonists Adjuvants, Immunologic Breast Neoplasms Bone Density Conservation Agents Selective Estrogen Receptor Modulators Hormones |
Tamoxifen Carcinoma Carcinoma, Ductal Estrogen Receptor Modulators Carcinoma in Situ Citrate Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial |
Estrogen Antagonists Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Skin Diseases Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Bone Density Conservation Agents Selective Estrogen Receptor Modulators Tamoxifen |
Pharmacologic Actions Carcinoma Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms, Ductal, Lobular, and Medullary Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial |