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Randomized Phase II 2 x 2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-Poor/HER2-Negative Resectable Breast Cancer
Provider Data DescriptionThe NCT00861705-D1-Dataset.csv (aeclean) dataset is one of 2 datasets associated with PubMed ID 25092775. This dataset contains adverse event data for each treated patient (N=443).
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase II trial studies how well paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
ConditionsMale Breast Carcinoma Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7 Stage IIIA Breast Cancer AJCC v7 Triple-Negative Breast Carcinoma
Arms InterventionArm I (paclitaxel, doxorubicin, cyclophosphamide) - Active Comparator Arm II (paclitaxel, ddAC, bevacizumab) - Experimental Arm III (paclitaxel, ddAC, carboplatin) - Experimental Arm IV (paclitaxel, ddAC, bevacizumab, carboplatin) - Experimental
PubMed (PMID)35044810 25092775
Age Range18 Years and older (Adult, Older Adult)