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NSABP-B-47

Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer

Purpose:

Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can blockcancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether combination chemotherapy is more effective with trastuzumab in treating breast cancer.

This randomized phase III clinical trialis studying chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer.

Eligibility:

Eligibility criteriainclude the following:

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Some patients in group one will receive a 1-hour infusion ofdocetaxel and an infusion of cyclophosphamide on day 1. Other patients in group one will receive an infusion of doxorubicin hydrochloride and an infusion of cyclophosphamide on day 1. Treatment may repeat every 2 or 3 weeks for four courses. Patients will then receive a 1-hour infusion of paclitaxel once a week for twelve doses.

Some patients in group two will receive a 1-hour infusion of docetaxel and an infusion of cyclophosphamide on day 1. Treatment may repeat every 3 weeks for six courses. At the same time, patients will receive a 30- to 90-minute infusion of trastuzumab on day 1. Treatment may repeat every 3 weeks for eleven courses. Other patients in group two will receive an infusion of doxorubicin hydrochloride and an infusion of cyclophosphamide on day 1. Treatment may repeat every 2 or 3 weeks for four courses. Patients will then receive a 1-hour infusion of paclitaxel once a week for thirteen doses. At the same time, patients will receive a 30- to 90-minute infusion of trastuzumab on day 1. Treatment may repeat every week for twelve doses. After finishing paclitaxel, patients will receive a 30- to 90-minute infusion of trastuzumab on day 1. Treatment may repeat every 3 weeks for twelve courses.

Tumor and blood samples may be collected periodically for laboratory studies.

After finishing treatment, patients will be evaluated every 6 months for 5 years and then every year for 5 years.

Trial Contact Information

Blanche Reiner RN, OCN 610-738-2515

Nona Blauvelt MSN, AOCN 610-738-2522

Last Updated: 6/11/2012