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Breast

CALGB 40603: 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

Unique Data Set IDBreast_Allianc_2009_162
DownloadableYes
SponsorAlliance for Clinical Trials in OncologyData ProviderAlliance for Clinical Trials in OncologyTotal Study Enrolled Patients454Comparator (Control) Arm Enrolled Patients0Experimental (Active) Arm Enrolled Patients443RandomizationYesClinicalTrial.gov IDNCT00861705ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00861705?term=NCT00861705&rank=1
Study PhaseClinical Study Phase IIBBlinding MethodOpen Label StudyType(s) of dataBoth comparator and experimental arm dataIntervention TypeChemotherapyData Set TypeADS

Clinical Trial Title

CALGB 40603: 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

Trial Summary and Conditions

This 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. Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment Active Comparator: Arm I (paclitaxel, doxorubicin, cyclophosphamide) Patients receive paclitaxel IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19. Experimental: Arm II (paclitaxel, ddAC, bevacizumab) Patients receive paclitaxel and ddAC as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17. Experimental: Arm III (paclitaxel, ddAC, carboplatin) Patients receive paclitaxel and ddAC as in Arm I. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10. Experimental: Arm IV (paclitaxel, ddAC, bevacizumab, carboplatin) Patients receive paclitaxel and ddAC as in Arm I, bevacizumab as in Arm II, and carboplatin as in Arm III.

Data Summary

Control and experimental arm data files include data on efficacy, demographics, etc. See the data dictionary provided for more details.

Study Objectives

PRIMARY 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.

Outcome Measures

Primary: I. Pathologic Complete Response (pCR) in the Breast. Secondary: Pathologic Complete Response (pCR) in the Breast and Axilla. Pathologic Stage in the Breast and in the Breast Plus Axilla. Clinical/Radiographic Response Assessed by Tumor Measurement. Overall Survival. Recurrence-free Survival. Time to First Failure. Incidence and Severity of Post-op Complications.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: 40603 protocol.pdf

CRF: 40603_CRF.pdf

DATA DICTIONARY: 40603_datadictionary.pdf

DATA (ACTIVE ARM): treated2.csv

DATA (ACTIVE ARM): aeclean.csv