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Therapeutic Areas: Oncology | Obstetrics/Gynecology (Women’s Health) | Family Medicine
Disease Category: Breast Cancer
Location: United States, WV

Clinical Trial Details


Research Study Summary

NSABP B-43: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy


The primary aim is to determine the value of trastuzumab given during radiation therapy (RT) compared to RT alone in preventing the subsequent occurrence of ipsilateral breast cancer recurrence, ipsilateral skin cancer recurrence, or ipsilateral DCIS (IIBCR-SCR-DCIS) in women with HER2-positive DCIS resected by lumpectomy.

The primary endpoint is time from randomization to IIBCR-SCR-DCIS defined as ipsilateral invasive breast cancer, ipsilateral skin cancer recurrence, or ipsilateral DCIS. An IIBCR-SCR-DCIS event is defined as recurrent tumor in the ipsilateral breast parenchyma, skin of the ipsilateral breast or ipsilateral DCIS occurring after lumpectomy. In the determination of time to an IIBCR-SCR-DCIS, no statistical censoring will be performed with respect to any previous local, regional, distant recurrences or second primary cancers.

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West Virginia University - Clinical Trials Research Unit
1637 Health Sciences South, PO Box 9260
Morgantown, WV 26506
Phone: 304-293-7374

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CW ID: 165568

Date Last Changed: April 10, 2014

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