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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 CancerUnique Dataset IDBreast_Allianc_2008_158
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)
Control arm data files include data on efficacy, demographics, etc.
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.
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 ]
To gain access to the data and analytic tools click here.
DATA DICTIONARY: c40502_datadictionary.pdf
DATA (COMPARATOR ARM): c40502_efficacy.csv
DATA (COMPARATOR ARM): c40502_cycles.csv
DATA (COMPARATOR ARM): c40502_ae.csv