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Sponsored by: |
European Institute of Oncology |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002720 |
RATIONALE: Surgery to remove axillary lymph nodes may be an effective treatment for women with breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of therapy with or without axillary lymph node dissection following quadrantectomy in treating older women with stage I breast cancer that is estrogen receptor positive.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: tamoxifen citrate Procedure: conventional surgery |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | QUADRANTECTOMY PLUS AXILLARY DISSECTION VERSUS QUADRANTECTOMY ALONE IN MAMMOGRAPHIC STAGE T1N0 BREAST CANCER PATIENTS AGED OVER 65 YEARS |
Estimated Enrollment: | 642 |
Study Start Date: | December 1995 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center. Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 642 patients will be accrued for this study within 3 years.
Ages Eligible for Study: | 65 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life Expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Italy | |
Istituto Nazionale per lo Studio e la Cura dei Tumori | |
Milano (Milan), Italy, 20133 |
Study Chair: | Gabriele Martelli, MD | Fondazione Istituto Nazionale dei Tumori |
Study ID Numbers: | CDR0000064573, CNR-9502, EU-95020 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002720 |
Health Authority: | United States: Federal Government |
stage I breast cancer |
Skin Diseases Citric Acid Breast Neoplasms Tamoxifen Breast Diseases |
Estrogen Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents |
Selective Estrogen Receptor Modulators Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses |