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NCI HIGH PRIORITY CLINICAL TRIAL --- Phase III Randomized Trial of Adjuvant Tamoxifen vs Placebo Following Breast Irradiation in Patients Who Have Undergone Lumpectomy for Noninvasive Intraductal Carcinoma (DCIS) 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 IIITreatmentCompletedpre/postmenopausalNCINSABP-B-24

Objectives

I.  Determine, in a Phase III setting, the efficacy of lumpectomy followed by 
breast irradiation with vs. without adjuvant tamoxifen in preventing the 
subsequent occurrence of ipsilateral and contralateral invasive breast cancer 
in patients with noninvasive intraductal cancer (DCIS).

II.  Determine the efficacy of prolonged adjuvant tamoxifen vs. placebo 
following lumpectomy and breast irradiation in preventing subsequent 
occurrence of ipsilateral and contralateral noninvasive (DCIS or LCIS) breast 
cancers in these patients.

Entry Criteria

Disease Characteristics:


Histologically proven, noninvasive intraductal carcinoma
(DCIS) of the breast, including mixed intraductal and lobular
in situ (LCIS) disease

Breast-conserving definitive surgery must be performed within
8 weeks of histologic diagnosis

  Bilateral malignancy excludes

  Contralateral mass excludes unless proven benign on biopsy

  Axillary dissection not required; if performed, all nodes
  must be histologically negative

  Suspicious palpable ipsilateral or contralateral axillary
  nodes and palpable supra- or infraclavicular nodes must be
  biopsied and must be negative for malignancy

The following disease distributions are eligible for
randomization provided surgical margins are free of grossly
evident disease (microscopic involvement of the margins with
DCIS or LCIS permitted, if so determined by the pathologist
and/or surgeon):

  Single mass or cluster of calcifications detected
  clinically or mammographically

  More than 1 mass or cluster of calcifications in the same
  or separate quadrants provided cosmetically acceptable
  surgery is possible

  Single or multiple masses or single or multiple clusters of
  calcifications with mammographic evidence of scattered
  calcifications considered by the radiologist to be of an
  indeterminate nature (suspicious scattered calcifications
  permitted without biopsy confirmation; if biopsied, must be
  noninvasive)

Diffuse scattered microcalcifications determined
radiologically to be suspicious permitted provided DCIS is
demonstrated on biopsy

Randomization must occur within 56 days after surgery

Hormone receptor status:
  Not specified


Prior/Concurrent Therapy:


Biologic therapy:
  No prior immunotherapy for present disease allowed

Chemotherapy:
  No prior chemotherapy for present disease allowed

Endocrine therapy:
  No prior endocrine therapy for present disease allowed

Radiotherapy:
  No prior radiotherapy for present disease allowed

Surgery:
  Breast conservation surgery for present disease required
  Re-excision to obtain histologically clear margins allowed
  Randomization must occur no more than 56 days after surgery

Other:
  Prior oophorectomy allowed for reasons other than malignancy
  Sex hormones (e.g., birth control pills, replacement
     therapy) must be discontinued while on protocol


Patient Characteristics:


Age:
  18 to 75

Sex:
  Females only

Menopausal status:
  Pre- and postmenopausal

Performance status:
  Not specified

Life expectancy:
  At least 10 years excluding the breast cancer

Hematopoietic:
  WBC at least 4,000/mm3
  Platelet count at least 100,000/mm3

Hepatic:
  Bilirubin no greater than 1.5 mg/dL or within normal limits
  SGOT no greater than 60 IU/mL or within normal limits

Renal:
  Not specified

Other:
  No prior or concurrent other malignancy except:
     Adequately treated nonmelanomatous skin cancer
     Surgically treated in situ cervical cancer
  No nonmalignant systemic disease that would preclude
     randomization to either arm or prevent prolonged
     follow-up
  No psychiatric or addictive disorder that would preclude
     informed consent
  Not pregnant 

Expected Enrollment

1,800 patients will be randomized.  The accrual rate is anticipated to be 360 
patients/year.

Outline

Randomized, double-blind study.

Arm I:  Radiotherapy plus Antiestrogen Therapy.  Irradiation of remaining 
breast tissue using Co60 or linear accelerators with a minimum energy of 4 MV, 
with electrons, superficial, or orthovoltage equipment with energies of 
100-300 KV used to boost the operative area; plus Tamoxifen, TMX, NSC-180973.

Arm II:  Radiotherapy plus Placebo.  Irradiation as in Arm I; plus Placebo.

Published Results

Allred DC, Anderson SJ, Paik S, et al.: Adjuvant tamoxifen reduces subsequent breast cancer in women with estrogen receptor-positive ductal carcinoma in situ: a study based on NSABP protocol B-24. J Clin Oncol 30 (12): 1268-73, 2012.[PUBMED Abstract]

Julian TB, Land SR, Wang Y, et al.: Is boost therapy necessary in the treatment of DCIS? [Abstract] J Clin Oncol 26 (suppl 15): A-537, 2008.

Fisher ER, Land SR, Saad RS, et al.: Pathologic variables predictive of breast events in patients with ductal carcinoma in situ. Am J Clin Pathol 128 (1): 86-91, 2007.[PUBMED Abstract]

Allred D, Bryant J, Land S, et al.: Estrogen receptor expression as a predictive marker of the effectiveness of tamoxifen in the treatment of DCIS: findings from NSABP Protocol B-24. [Abstract] Breast Cancer Res Treat 76 (Suppl 1): A-30, 2002.

Fisher B, Land S, Mamounas E, et al.: Prevention of invasive breast cancer in women with ductal carcinoma in situ: an update of the national surgical adjuvant breast and bowel project experience. Semin Oncol 28 (4): 400-18, 2001.[PUBMED Abstract]

Fisher B, Dignam J, Wolmark N, et al.: Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomised controlled trial. Lancet 353 (9169): 1993-2000, 1999.[PUBMED Abstract]

Related Publications

Petrelli F, Barni S: Tamoxifen added to radiotherapy and surgery for the treatment of ductal carcinoma in situ of the breast: a meta-analysis of 2 randomized trials. Radiother Oncol 100 (2): 195-9, 2011.[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]

Vogel VG, Costantino JP, Wickerham DL, et al.: National surgical adjuvant breast and bowel project update: prevention trials and endocrine therapy of ductal carcinoma in situ. Clin Cancer Res 9 (1 Pt 2): 495S-501S, 2003.[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]

Trial Contact Information

Trial Lead Organizations

National Surgical Adjuvant Breast and Bowel Project

Norman Wolmark, MD, Protocol chair (Contact information may not be current)
Ph: 412-623-3205

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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