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Type(s) of Cancer
Breast
Study Phase
Phase 2B
Study Completion Date
2009
NCT00861705Uploaded 04-14-2017
Available for Download
PDS UID: Breast_Allianc_2009_162
N/A
Provider Information
Provider Data DescriptionPRIMARY OBJECTIVES: I. To determine whether adding bevacizumab to neoadjuvant weekly paclitaxel (+/- carboplatin) and subsequent dose-dense doxorubicin and cyclophosphamide (ddAC) significantly increases the rate of pathologic complete response (pCR) in the breast in patients with HR-poor/HER2 (-), resectable breast cancer. II. To determine whether adding carboplatin every 3 weeks to neoadjuvant weekly paclitaxel followed by ddAC (+/- bevacizumab) significantly raises the rate of pCR in the breast in patients with HR-poor/HER2(-), resectable breast cancer. III. To determine whether adding bevacizumab every 2 weeks to neoadjuvant weekly paclitaxel (+/- carboplatin) and subsequent ddAC significantly raises the rate of pCR in the breast in patients with basal-like breast cancers, as defined by gene expression array. IV. To determine whether adding carboplatin every 3 weeks to neoadjuvant weekly paclitaxel followed by ddAC (+/- bevacizumab) significantly raises the rate of pCR in the breast in patients with basal-like breast cancers, as defined by gene expression array. SECONDARY OBJECTIVES: Please see the protocol for more details.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderAlliance for Clinical Trials in Oncology
Partial set or SubsetOriginal Data
Patients in dataset454
# of Patients Control115
# of Patients Experimental339
DOIhttps://doi.org/10.34949/hpp1-ws07
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryN/A
ConditionsN/A
Intervention TypeChemotherapy
Drug(s)N/A
Total EnrolledN/A
RandomizationN/A
Blinding MethodN/A
Arms InterventionN/A
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)N/A
Age RangeN/A
Files:
PROTOCOL40603 protocol.pdf
CRF40603_CRF.pdf
DATA DICTIONARY40603_datadictionary.pdf
DATA (ACTIVE ARM)treated2.csv
DATA (ACTIVE ARM)aeclean.csv
DATA (ACTIVE ARM)PoC_aeclean_xomic.csv
DATA (ACTIVE ARM)PoC_treated2_xomic.csv
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