Alert icon

To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action.
This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm.
To view information about this, please visit the FAQ. If you have any further questions, please contact us.

Breast

CALGB 40502: A Randomized Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound Nab-paclitaxel or Ixabepilone With or Without Bevacizumab as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer

Unique Data Set IDBreast_Allianc_2008_158
DownloadableYes
SponsorAlliance for Clinical Trials in OncologyData ProviderAlliance for Clinical Trials in OncologyTotal Study Enrolled Patients799Comparator (Control) Arm Enrolled Patients283Experimental (Active) Arm Enrolled Patients0RandomizationYesClinicalTrial.gov IDNCT00785291ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00785291
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataBoth comparator and experimental arm dataIntervention TypeChemotherapyData Set TypeADS

Clinical Trial Title

CALGB 40502: A Randomized Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound Nab-paclitaxel or Ixabepilone With or Without Bevacizumab as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer

Trial Summary and Conditions

This randomized phase III trial studies the side effects and how well different chemotherapy regimens with or without bevacizumab work in treating patients with stage IIIC or stage IV breast cancer. Drugs used in chemotherapy, such as paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel), and ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may block tumor growth by targeting certain cells and slowing the growth of blood vessels to the tumor. It is not yet known which treatment regimen is more effective in treating patients with breast cancer. Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment This is a randomized phase III trial, a 3-arm study with equally weighted randomization. Arm A = Control, Paclitaxel (Pac) Arm B = Experimental, Nab-paclitaxel (Nab) Arm C = Experimental, Ixabepilone (Ixa) Each arm +/- Bevacizumab (Bev)

Data Summary

Control arm data files include data on efficacy, demographics, etc.

Study Objectives

Primary objective I. To compare the progression-free survival (PFS) in patients with metastatic breast cancer receiving nab-paclitaxel versus paclitaxel (control arm), and to separately compare PFS in patients receiving ixabepilone versus paclitaxel. Concomitant bevacizumab is allowed, but is not required; the plan to use bevacizumab must be declared at registration and is a stratification factor. Bevacizumab is supplied by CTEP. Secondary objectives Please refer to the secondary objectives as outline in the protocol.

Outcome Measures

Primary Outcome Measures: I. Progression Free Survival [ Time Frame: Time from randomization to progression or death due to any cause, whichever occurs first (up to 5 years) ] [ Designated as safety issue: No ] Secondary Outcome Measures: II. Objective Tumor Response Rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ] III. Time to Treatment Failure [ Time Frame: Time from randomization until progression, death, or yearly termination of protocol therapy (up to 5 years) ] [ Designated as safety issue: No ] IV. 12 Month Progression Free Survival [ Time Frame: 12 months ] [ Designated as safety issue: No ] V. Overall Survival [ Time Frame: Time from randomization to death or last follow-up (up to 5 years) ] [ Designated as safety issue: No ]

Available Downloads:

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

PROTOCOL: c40502_protocol.pdf

CRF: c40502_CRF.pdf

DATA DICTIONARY: c40502_datadictionary.pdf

DATA (COMPARATOR ARM): c40502_efficacy.csv

DATA (COMPARATOR ARM): c40502_cycles.csv

DATA (COMPARATOR ARM): c40502_ae.csv