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Phase III Total Mastectomy/Axillary Dissection vs Segmental Mastectomy/Axillary Dissection with or without Radiotherapy for Potentially Curable Breast Carcinoma

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompleted70 and underNCINSABP-B-06
PBCTG-B06

Objectives

I.  Compare the following therapeutic procedures in patients with breast 
cancer amenable to segmental mastectomy:  total mastectomy plus axillary 
dissection; segmental mastectomy plus axillary dissection; segmental 
mastectomy plus axillary dissection plus radiotherapy.
II.  Evaluate the efficacy of chemotherapy with melphalan and 5-fluorouracil 
in patients with positive axillary nodes who have been treated by one of the 
above surgical procedures, and the effects of this chemotherapy on the ovarian 
function of premenopausal patients.
III.  Determine whether cosmetically acceptable preservation of the breast can 
be achieved without unfavorably influencing patient response, survival and 
morbidity.
IV.  Determine the clinical significance of microscopic multicentricity of 
breast tumors.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Female patients not over the age of 
70 years who have a potentially curable breast carcinoma amenable to segmental 
resection.  The tumor must be confined to the breast (with or without clinical 
involvement of the ipsilateral axilla), be no greater than 4 cm in greatest 
dimension, and be movable in relation to skin and underlying chest wall.  
Palpable axillary nodes must be movable in relation to the chest wall and 
neurovascular bundle.  There may be no evidence of skin involvement (edema, 
ulceration, infiltration).  There may have been no previous treatment for the 
current breast tumor, other than needle or incisional biopsy, and no history 
of treatment of any kind for a prior breast cancer.  Patients must not be 
pregnant or lactating.  There may be no history of a second malignancy other 
than effectively treated nonmelanomatous skin cancer.  Patients with multiple 
tumor masses in the same breast are ineligible unless all but one of the 
masses has been proved histologically benign.

Expected Enrollment

Protocol closed February 1984.

Outline

Randomized study.  All patients with positive axillary nodes following surgery 
entry Regimen A.
Arm I:  Surgery.  Total mastectomy plus axillary dissection.
Arm II:  Surgery.  Segmental mastectomy plus axillary dissection.
Arm III:  Surgery plus Radiotherapy.  Segmental mastectomy plus axillary 
dissection, followed by irradiation of the breast with Cobalt-60 or linear 
accelerator x-rays.
Regimen A:  2-Drug Chemotherapy.  Melphalan, L-PAM, NSC-8806; 5-Fluorouracil, 
5-FU, NSC-19893.

Published Results

Fisher B, Anderson S, Bryant J, et al.: Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med 347 (16): 1233-41, 2002.[PUBMED Abstract]

Fisher ER, Anderson S, Tan-Chiu E, et al.: Fifteen-year prognostic discriminants for invasive breast carcinoma: National Surgical Adjuvant Breast and Bowel Project Protocol-06. Cancer 91 (8 Suppl): 1679-87, 2001.[PUBMED Abstract]

Fisher B, Anderson S, Redmond CK, et al.: Reanalysis and results after 12 years of follow-up in a randomized clinical trial comparing total mastectomy with lumpectomy with or without irradiation in the treatment of breast cancer. N Engl J Med 333 (22): 1456-61, 1995.[PUBMED Abstract]

Fisher ER, Anderson S, Redmond C, et al.: Ipsilateral breast tumor recurrence and survival following lumpectomy and irradiation: pathological findings from NSABP protocol B-06. Semin Surg Oncol 8(3): 161-166, 1992.

Fisher B, Redmond C, Poisson R, et al.: Eight-year results of a randomized clinical trial comparing total mastectomy and lumpectomy with or without irradiation in the treatment of breast cancer. N Engl J Med 320 (13): 822-8, 1989.[PUBMED Abstract]

Fisher B, Redmond C, Fisher ER, et al.: Relative worth of estrogen or progesterone receptor and pathologic characteristics of differentiation as indicators of prognosis in node negative breast cancer patients: findings from National Surgical Adjuvant Breast and Bowel Project Protocol B-06. J Clin Oncol 6 (7): 1076-87, 1988.[PUBMED Abstract]

Rockette H, Fisher B, Fisher E, et al.: Prognostic significance of tumor estrogen and progesterone receptor (ER, PR) nuclear and histologic grade (NG, HG) in node negative breast cancer patients: findings from NSABP B-06. [Abstract] Proceedings of the American Society of Clinical Oncology 6: A-244, 63, 1987.

Fisher ER, Sass R, Fisher B, et al.: Pathologic findings from the National Surgical Adjuvant Breast Project (protocol 6). II. Relation of local breast recurrence to multicentricity. Cancer 57 (9): 1717-24, 1986.[PUBMED Abstract]

Fisher B, Bauer M, Margolese R, et al.: Five-year results of a randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer. N Engl J Med 312 (11): 665-73, 1985.[PUBMED Abstract]

Related Publications

Deutsch M, Land SR, Begovic M, et al.: The incidence of lung carcinoma after surgery for breast carcinoma with and without postoperative radiotherapy. Results of National Surgical Adjuvant Breast and Bowel Project (NSABP) clinical trials B-04 and B-06. Cancer 98 (7): 1362-8, 2003.[PUBMED Abstract]

Fisher B, Bryant J, Dignam JJ, et al.: Tamoxifen, radiation therapy, or both for prevention of ipsilateral breast tumor recurrence after lumpectomy in women with invasive breast cancers of one centimeter or less. J Clin Oncol 20 (20): 4141-9, 2002.[PUBMED Abstract]

Land SR, Begovic HS, Wieand HS, et al.: Lung cancer following radiotherapy (RT) for primary breast cancer in National Surgical Adjuvant Breast Project (NSABP) trials B-04 and B-06. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1532, 2002.

Fisher B, Dignam J, Tan-Chiu E, et al.: Prognosis and treatment of patients with breast tumors of one centimeter or less and negative axillary lymph nodes. J Natl Cancer Inst 93 (2): 112-20, 2001.[PUBMED Abstract]

Wapnir I, Anderson S, Tan-Chiu E, et al.: Ipsilateral breast tumor recurrence (IBTR) and survival in NSABP node-positive breast cancer protocols. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A315, 2000.

Christian MC, McCabe MS, Korn EL, et al.: The National Cancer Institute audit of the National Surgical Adjuvant Breast and Bowel Project Protocol B-06. N Engl J Med 333 (22): 1469-74, 1995.[PUBMED Abstract]

Fisher ER, Kenny JP, Sass R, et al.: Medullary cancer of the breast revisited. Breast Cancer Res Treat 16 (3): 215-29, 1990.[PUBMED Abstract]

Margolese R, Poisson R, Shibata H, et al.: The technique of segmental mastectomy (lumpectomy) and axillary dissection: A syllabus from the National Surgical Adjuvant Breast Project workshops. Surgery 102 (5): 828-34, 1987.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

National Surgical Adjuvant Breast and Bowel Project

Norman Wolmark, MD, Protocol chair
Ph: 412-359-3336; 866-680-0004

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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