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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00026845 |
Purpose
RATIONALE: It is not yet known which combination of surgeries is more effective in reducing side effects and improving recovery in treating breast cancer.
PURPOSE: This randomized phase III trial is comparing how well axillary lymph node dissection with either mastectomy or excisional biopsy plus radiation therapy works in treating women with stage I or stage II breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Procedure: axillary lymph node dissection Procedure: biopsy Procedure: therapeutic conventional surgery Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | The Treatment Of Clinical Stage I And II Carcinoma Of The Breast With Mastectomy And Axillary Dissection Versus Excisional Biopsy, Axillary Dissection And Definitive Irradiation |
| Estimated Enrollment: | 237 |
| Study Start Date: | September 1979 |
| Estimated Study Completion Date: | February 2006 |
| Estimated Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Active Comparator
Patients undergo total mastectomy and axillary dissection.
|
Procedure: axillary lymph node dissection
Patients undergo axillary lymph node dissection
Procedure: therapeutic conventional surgery
Patients undergo total mastectomy
|
|
Arm II: Experimental
Patients undergo excisional biopsy and axillary dissection followed by whole breast radiotherapy and a boost to the tumor bed. Patients with positive axillary dissections undergo radiotherapy to the supraclavicular nodes.
|
Procedure: axillary lymph node dissection
Patients undergo axillary lymph node dissection
Procedure: biopsy
Patients undergo excisional biopsy
Radiation: radiation therapy
Patients undergo radiation therapy
|
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
In both arms, patients with positive nodes receive cyclophosphamide and doxorubicin.
Patients are followed for at least 20 years.
PROJECTED ACCRUAL: A total of 237 patients (116 for arm I and 121 for arm II) were accrued for this study within 8 years.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
More Information
| Responsible Party: | NCI - Radiation Oncology Branch; ROB ( Nicole L. Simone ) |
| Study ID Numbers: | CDR0000256918, NCI-79-C-0111 |
| Study First Received: | November 14, 2001 |
| Last Updated: | April 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00026845 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I breast cancer stage II breast cancer |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |