Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
American College of Surgeons National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003855 |
RATIONALE: Surgery to remove lymph nodes in the armpit may remove cancer cells that have spread from tumors in the breast.
PURPOSE: Randomized phase III trial to determine the effectiveness of removing lymph nodes in the armpit in treating women who have stage I or stage IIA breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Procedure: conventional surgery Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node |
Estimated Enrollment: | 1900 |
Study Start Date: | April 1999 |
OBJECTIVES:
OUTLINE: This is a randomized study. After segmental mastectomy and sentinel lymph node dissection, patients are stratified according to age (50 and under vs over 50), estrogen receptor status (positive vs negative), and tumor size (no greater than 1 cm vs greater than 1 cm but no greater than 2 cm vs greater than 2 cm). Patients are randomized to one of two treatment arms.
Patients are followed at 30 days, at 6, 12, 18, 30, and 36 months, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 1,900 patients (950 per treatment arm) will be accrued for this study within 3.8 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage I or IIA (T1 or T2, N0, M0) invasive breast carcinoma amenable to lumpectomy
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:
No pre-pectoral breast implant
Study Chair: | Armando E. Giuliano, MD | John Wayne Cancer Institute at Saint John's Health Center |
Study ID Numbers: | CDR0000067018, ACOSOG-Z0011, GUMC-00153 |
Study First Received: | November 1, 1999 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00003855 |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |