CLINICAL TRIAL SUMMARY

MDACC Study No:NSABPFB-7 (clinicaltrials.gov NCT No: NCT01008150)
Title:A Phase II Randomized Clinical Trial Evaluating Neoadjuvant Therapy Regimens with Weekly Paclitaxel plus Neratinib or Trastuzumab or Neratinib and Trastuzumab Followed by Doxorubicin and Cyclophosphamide with Postoperative Trastuzumab in Women with Locally Advanced HER2 Positive Breast Cancer
Principal Investigator:Vicente Valero
Treatment Agent:Cyclophosphamide; Doxorubicin; Herceptin; Neratinib; Paclitaxel
Study Status:Open
Study Description:The goal of this clinical research study is to learn how breast cancer tumors
such as yours are affected by a drug called neratinib in combination with
paclitaxel, or in combination with paclitaxel and trastuzumab, as compared with
standard treatment of trastuzumab and paclitaxel given as breast cancer
treatments before surgery. The safety of these drugs will also be studied.

A second goal of the study is to learn if adding neratinib to standard
treatments for HER2-positive breast cancer will prevent breast cancer from
returning.

Researchers will look at whether adding neratinib to standard treatments will
help women with HER2-positive breast cancer live longer.

Researchers also want to learn more about the possible side effects that might
result from the combination of drugs used in this study.

Hide details for General InformationGeneral Information

Disease Group:Breast
Phase of Study:Phase II
Treatment Agents:Cyclophosphamide
Doxorubicin
Herceptin
Neratinib
Paclitaxel
Treatment Location:Both at MDACC & and Other Sites
Estimated Length of Stay in Houston:
Supported By:NSABP
Return Visit:
Home Care:


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Vicente Valero
Dept:Breast Medical Oncology
For Clinical Trial Enrollment:713-792-3965
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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