Clinical Research Details
Title:
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
Purpose:
The purpose of this study is to determine the value of trastuzumab given during radiation therapy compared to radiation therapy alone in preventing the subsequent occurrence of ipsilateral breast cancer recurrence, ipsilateral skin cancer recurrence or ipsilateral ductal carcinoma in situ (DCIS) in women with HER2-positive DCIS resected by lumpectomy.
Study Number:
202083081909
Number of Patients:
2000
Elgibility:
Adult females = 18 years old with the following six criteria:
1) Tumor must be histologically ductal carcinoma in situ, 2) ECOG performance status of 0 or 1, 3) DCIS must be HER2-positive as determined by central testing, 4) All DCIS must have been resected by lumpectomy, 5) Margins of the resected specimen must be histologically free of DCIS and 6) the interval between the last surgery for excision of DCIS and randomization must be no more than 120 days.
Treatment:
Participants will be randomized to one of two groups: radiation therapy or radiation therapy plus trastuzumab.
Principal Investigator:
Enrollment Phone:
(708) 327-3154