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Clinical Trials (PDQ®)

Phase III Randomized Study of Postoperative Radiotherapy Following Segmental Mastectomy and Axillary Dissection in Patients with Noninvasive Intraductal Adenocarcinoma of the Breast

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompleted18 and overNCINSABP-B-17
CLB-8793, MAOP-1285, NCOG-NSABP-B-17

Objectives

I.  Test the hypothesis that segmental mastectomy with or without axillary 
dissection followed by postoperative breast irradiation is more effective than 
segmental mastectomy with or without axillary dissection alone in controlling 
the subsequent occurrence of ipsilateral invasive and/or noninvasive cancers 
in patients with noninvasive intraductal adenocarcinoma.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Female patients aged 18 years and 
over who have undergone a segmental mastectomy for histologically confirmed 
noninvasive intraductal adenocarcinoma (those with mixed intraductal and 
lobular in situ are also eligible).  If axillary dissection was performed, all 
axillary lymph nodes must be negative for tumor on histologic examination.  
The interval between the definitive operation and the proposed randomization 
may be no more than 56 days.  Patients whose histologic diagnosis (including 
excisional, incisional, or needle biopsy and aspiration cytology) was 
established more than 8 weeks prior to segmental mastectomy are ineligible.  
The life expectancy, excluding the diagnosis of breast cancer, must be at 
least 10 years, and patients must not be pregnant at the time of the proposed 
randomization.  Patients with diffuse microcalcifications in whom segmental 
mastectomy would be inadequate to resect all foci are ineligible, as are those 
presenting with more than one tumor mass in the same breast unless it is 
demonstrated that only one of the masses contains intraductal cancer, i.e., 
all other masses are benign.  The presence of one or more ipsilateral axillary 
lymph nodes that are positive for tumor on histologic examination excludes, as 
does bilateral malignancy or a mass in the contralateral breast unless there 
is biopsy proof that the mass is not a malignancy (mirror image biopsy or 
blind biopsy is not required).  Patients with suspicious palpable nodes in the 
contralateral axilla or with palpable supraclavicular or infraclavicular nodes 
are ineligible unless there is biopsy evidence that these nodes are not 
involved with tumor.  There may be no previous or concurrent malignancy 
(including prior noninvasive breast cancer) except for squamous or basal cell 
carcinoma of the skin that has been effectively treated and carcinoma in situ 
of the cervix that has been treated operatively only.  Prior therapy for the 
present breast cancer, including radiotherapy, chemotherapy, immunotherapy, 
and/or hormonal therapy, is not allowed; patients receiving hormonal therapy 
such as birth control pills or replacement therapy are eligible if this 
therapy is discontinued while on protocol.  Nonmalignant systemic disease 
(e.g., cardiovascular, renal, or hepatic) that would preclude any of the 
treatment options or prevent prolonged follow-up excludes, as do any 
psychiatric or addictive disorders that would preclude obtaining informed 
consent.  Patients with Paget's disease of the nipple, those with breasts 
deemed too large to permit satisfactory irradiation, and those who received 
breast irradiation following segmental mastectomy but prior to randomization 
are ineligible.  A registry of lobular in-situ patients will be initiated; 
such patients must be registered within 56 days following definitive surgery.  
The same entry information and follow-up requirements already outlined in the 
protocol are to be utilized.  However, the primary therapies are at the 
discretion of the investigators.

Expected Enrollment

As of 05/90, it was anticipated that the required 775 patients would be 
entered by 12/31/90.

Outline

Randomized study.
Arm I:  Postoperative Radiotherapy.  Irradiation of all remaining ipsilateral 
breast tissue using Co60 or linear accelerator x-rays.
Arm II:  No postoperative therapy.

Published Results

Fisher ER, Land SR, Fisher B, et al.: Pathologic findings from the National Surgical Adjuvant Breast and Bowel Project: twelve-year observations concerning lobular carcinoma in situ. Cancer 100 (2): 238-44, 2004.[PUBMED Abstract]

Habel LA, Dignam JJ, Land SR, et al.: Mammographic density and breast cancer after ductal carcinoma in situ. J Natl Cancer Inst 96 (19): 1467-72, 2004.[PUBMED Abstract]

Fisher ER, Dignam J, Tan-Chiu E, et al.: Pathologic findings from the National Surgical Adjuvant Breast Project (NSABP) eight-year update of Protocol B-17: intraductal carcinoma. Cancer 86 (3): 429-38, 1999.[PUBMED Abstract]

Fisher B, Dignam J, Wolmark N, et al.: Lumpectomy and radiation therapy for the treatment of intraductal breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-17. J Clin Oncol 16 (2): 441-52, 1998.[PUBMED Abstract]

Fisher ER, Costantino J, Fisher B, et al.: Pathologic findings from the National Surgical Adjuvant Breast Project (NSABP) Protocol B-17. Five-year observations concerning lobular carcinoma in situ. Cancer 78 (7): 1403-16, 1996.[PUBMED Abstract]

Solin LJ, Kurtz J, Fourquet A, et al.: Fifteen-year results of breast-conserving surgery and definitive breast irradiation for the treatment of ductal carcinoma in situ of the breast. J Clin Oncol 14 (3): 754-63, 1996.[PUBMED Abstract]

Fisher ER, Costantino J, Fisher B, et al.: Pathologic findings from the National Surgical Adjuvant Breast Project (NSABP) Protocol B-17. Intraductal carcinoma (ductal carcinoma in situ). The National Surgical Adjuvant Breast and Bowel Project Collaborating Investigators. Cancer 75 (6): 1310-9, 1995.[PUBMED Abstract]

Fisher B, Costantino J, Redmond C, et al.: Lumpectomy compared with lumpectomy and radiation therapy for the treatment of intraductal breast cancer. N Engl J Med 328 (22): 1581-6, 1993.[PUBMED Abstract]

Fisher B, Costantino J, Wickerham L, et al.: Treatment of intraductal breast cancer (DCIS): results of NSABP B-17. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-80, 70, 1993.

Related Publications

Suh WW, Hillner BE, Pierce LJ, et al.: Cost-effectiveness of radiation therapy following conservative surgery for ductal carcinoma in situ of the breast. Int J Radiat Oncol Biol Phys 61 (4): 1054-61, 2005.[PUBMED Abstract]

Wickerham L: Tamoxifen--an update on current data and where it can now be used. Breast Cancer Res Treat 75 (Suppl 1): S7-12; discussion S33-5, 2002.[PUBMED Abstract]

McCaskill-Stevens W, Bryant J, Costantino J, et al.: Incidence of contralateral breast cancer (CBC), endometrial cancer (EC), and thromboembolic events (TE) in African American (AA) women receiving tamoxifen for treatment of primary breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A269, 2000.

Silverstein MJ, Lagios MD: Pathologic findings from the National Surgical Adjuvant Breast Project (NSABP) eight-year update of Protocol B-17. Cancer 88 (1): 242-4, 2000.[PUBMED Abstract]

Cutuli B: Is radiotherapy needed after adequate local excision of localized DCIS? Int J Fertil Womens Med 49 (5): 231-6, 2004 Sep-Oct.[PUBMED Abstract]

Fisher ER, Costantino J, Fisher B, et al.: Response - blunting the counterpoint. Cancer 75 (6): 1223-1227, 1995.

Page DL, Lagios MD: Pathologic analysis of the National Surgical Adjuvant Breast Project (NSABP) B-17 Trial. Unanswered questions remaining unanswered considering current concepts of ductal carcinoma in situ. Cancer 75 (6): 1219-22; discussion 1223-7, 1995.[PUBMED Abstract]

Wapnir IL, Dignam JJ, Fisher B, et al.: Long-term outcomes of invasive ipsilateral breast tumor recurrences after lumpectomy in NSABP B-17 and B-24 randomized clinical trials for DCIS. J Natl Cancer Inst 103 (6): 478-88, 2011.[PUBMED Abstract]

Julian TB, Land SR, Fourchotte V, et al.: Is sentinel node biopsy necessary in conservatively treated DCIS? Ann Surg Oncol 14 (8): 2202-8, 2007.[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

Mid-Atlantic Oncology Program

Philip Cohen, MD, Protocol chair (Contact information may not be current)
Ph: 202-741-2210

Clinical Research Program - Northern California Cancer Center

Robert Carlson, MD, Protocol chair
Ph: 650-725-6457; 800-756-9000

Cancer and Leukemia Group B

William Wood, MD, Protocol chair (Contact information may not be current)
Ph: 404-778-5180; 888-946-7447

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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