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Clinical Trials (PDQ®)

Comparison of Radical Mastectomy Versus Total Mastectomy Alone or with Radiotherapy for Resectable Breast Carcinoma

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedTreatmentCompletedno age specifiedNCINSABP-B-04
PBCTG-B04

Objectives

I.  Determine the adequacy of radical mastectomy versus total mastectomy, with 
or without radiotherapy, for the cure of recently diagnosed breast carcinoma.
II.  Correlate efficacy of partial versus total mastectomy plus radiotherapy 
with nodal involvement.
III.  Determine the effects of these treatments on rate and duration of 
response, rate of recurrence and duration of survival.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with resectable breast 
carcinoma, with positive or negative axillary nodes.

Expected Enrollment

Activated July 1971, closed as of September 1975 to patient entry (number of 
patients is not stated).  Follow-up only.

Outline

Randomized Study.
Arm I:  Radical Mastectomy.
Arm II:  Total Mastectomy.
Arm III:  Total Mastectomy plus Radiotherapy.

Published Results

Deutsch M, Land S, Begovic M, et al.: The incidence of arm edema in women with breast cancer randomized on the national surgical adjuvant breast and bowel project study B-04 to radical mastectomy versus total mastectomy and radiotherapy versus total mastectomy alone. Int J Radiat Oncol Biol Phys 70 (4): 1020-4, 2008.[PUBMED Abstract]

Deutsch M, Land SR, Begovic M, et al.: The incidence of arm edema in women with breast cancer randomized on the National Surgical Adjuvant Breast and Bowel Project (NSABP) study B-04 to radical mastectomy versus total mastectomy and radiotherapy versus total mastectomy alone. [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-128, S206, 2004.

Fisher B, Jeong JH, Anderson S, et al.: Twenty-five-year follow-up of a randomized trial comparing radical mastectomy, total mastectomy, and total mastectomy followed by irradiation. N Engl J Med 347 (8): 567-75, 2002.[PUBMED Abstract]

Fisher ER, Costantino J, Fisher B, et al.: Pathologic findings from the National Surgical Adjuvant Breast Project (Protocol 4). Discriminants for 15-year survival. National Surgical Adjuvant Breast and Bowel Project Investigators. Cancer 71 (6 Suppl): 2141-50, 1993.[PUBMED Abstract]

Fisher B, Redmond C, Fisher ER, et al.: Ten-year results of a randomized clinical trial comparing radical mastectomy and total mastectomy with or without radiation. N Engl J Med 312 (11): 674-81, 1985.[PUBMED Abstract]

Fisher ER, Sass R, Watkins G, et al.: Tissue mast cells in breast cancer. Breast Cancer Res Treat 5 (3): 285-91, 1985.[PUBMED Abstract]

Fisher ER, Fisher B, Sass R, et al.: Pathologic findings from the National Surgical Adjuvant Breast Project (Protocol No. 4). XI. Bilateral breast cancer. Cancer 54 (12): 3002-11, 1984.[PUBMED Abstract]

Fisher ER, Sass R, Fisher B: Pathologic findings from the National Surgical Adjuvant Project for Breast Cancers (protocol no. 4). X. Discriminants for tenth year treatment failure. Cancer 53 (3 Suppl): 712-23, 1984.[PUBMED Abstract]

Fisher ER, Palekar AS, Sass R, et al.: Scar cancers: pathologic findings from the National Surgical Adjuvant Breast Project (protocol no. 4) - IX. Breast Cancer Res Treat 3 (1): 39-59, 1983.[PUBMED Abstract]

Fisher ER, Redmond C, Fisher B: Pathologic findings from the National Surgical Adjuvant Breast Project. VIII. Relationship of chemotherapeutic responsiveness to tumor differentiation. Cancer 51 (2): 181-91, 1983.[PUBMED Abstract]

Fisher B, Wolmark N, Redmond C, et al.: Findings from NSABP Protocol No. B-04: comparison of radical mastectomy with alternative treatments. II. The clinical and biologic significance of medial-central breast cancers. Cancer 48 (8): 1863-72, 1981.[PUBMED Abstract]

Fisher B, Montague E, Redmond C, et al.: Findings from NSABP Protocol No. B-04-comparison of radical mastectomy with alternative treatments for primary breast cancer. I. Radiation compliance and its relation to treatment outcome. Cancer 46 (1): 1-13, 1980.[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]

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

Fisher B, Bauer M, Wickerham DL, et al.: Relation of number of positive axillary nodes to the prognosis of patients with primary breast cancer. An NSABP update. Cancer 52 (9): 1551-7, 1983.[PUBMED Abstract]

Fisher ER, Redmond C, Fisher B: Pathologic findings from the National Surgical Adjuvant Breast Project. VIII. Relationship of chemotherapeutic responsiveness to tumor differentiation. Cancer 51 (2): 181-91, 1983.[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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