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Type(s) of Cancer
Breast
Study Phase
Phase 2
Study Completion Date
2014-08-01
NCT00861705Uploaded 01-07-2023
Access via NCI by Request
PDS UID: nci-data-505
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 Information
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
Intervention TypeBiological: Bevacizumab
Drug: Carboplatin
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Drug(s)Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Paclitaxel
Drug: Carboplatin
Total Enrolled454
RandomizationRandomized
Blinding MethodNone
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
Secondary IDNCI-2009-01172
PubMed (PMID)35044810
25092775
Collaborator(s)N/A
Region(s)United States
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT00861705-D1
Data DictionaryNCT00861705-D1-Data-Dictionary_1.pdf
DATANCT00861705-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00861705-D2
Data DictionaryNCT00861705-D2-Data-Dictionary_1.pdf
DATANCT00861705-D2-Dataset_1.csv
OTHERREADME.pdf
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