Clinical Trial 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
- Principal Investigator
- Eric Donnelly
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.NSABP B-43
- This study will find out if adding trastuzumab to breast radiation therapy is more effective than radiation therapy without trastuzumab in preventing occurrence of breast cancer in the same breast, in the other breast, or in other parts of the body in patients with HER2-positive DCIS.
- DCIS is also known as intraductal or non-invasive breast cancer. DCIS means that the cancer cells are only in the milk ducts in the breast and have not spread to other breast tissue or to other parts of the body. Radiation therapy is the standard treatment for patients with DCIS. Trastuzumab has been shown to block the HER2 protein and to slow down or stop the growth of HER2-positive “invasive” breast cancers. Trastuzumab is only known to be effective in treating breast cancer that is HER2-positive. Therefore, a patient’s tumor must be tested to find out if it is HER2-positive before she can join this study. HER2-positive means that the cancer makes too much of a protein called HER2. Too much of this protein can cause normal cells to receive extra growth signals. This can turn a normal cell into a cancer cell and can make cancer cells grow faster. Trastuzumab is considered to be investigational (still being researched) because the Food and Drug Administration has not approved it for use in the treatment of DCIS.
Some of the eligibility criteria include:
- Participants cannot have history of heart disease
- Participants must have ductal carcinoma in situ (DCIS) that is HER2-ppositive.
- All the DCIS must have been resected (surgically removed) by lumpectomy.
- Participants must be 18 years old or older.
- Description of Treatment
- Participants for this study will be randomized into two groups. Each group will receive radiation therapy. Receiving radiation therapy after a lumpectomy is part of regular cancer care for DCIS. Participant’s radiation therapy treatments will take 3 to 6 weeks to complete depending on the treatment schedule. Only one group will receive 2 doses of trastuzumab during the time period they receive radiation therapy. Participants will receive Dose 1 of trastuzumab within 1 week before starting radiation therapy. Three weeks after Dose 1 of trastuzumab, Dose 2 will be given. Trastuzumab is given through a vein (IV).
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 05-May-16 01:45 AM
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