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Breast

A randomized, open-label, Phase 3 study of RPR109881 IV every 3 weeks versus capecitabine (Xeloda) tablets twice daily for 2 weeks in 3-week cycles in patients with metastatic breast cancer progressing after taxanes and anthracycline therapy (EFC6089)

Unique Data Set IDBreast_SanofiU_2004_135
DownloadableYes
SponsorSanofi US Services Inc.Data ProviderSanofiTotal Study Enrolled Patients438Comparator (Control) Arm Enrolled Patients217RandomizationYesClinicalTrial.gov IDNCT00081796ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00081796?term=EFC6089&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeChemotherapyData Set TypeOther

Clinical Trial Title

A randomized, open-label, Phase 3 study of RPR109881 IV every 3 weeks versus capecitabine (Xeloda) tablets twice daily for 2 weeks in 3-week cycles in patients with metastatic breast cancer progressing after taxanes and anthracycline therapy (EFC6089)

Trial Summary and Conditions

This will be a global multi-center, open-label, two-arm randomized, phase III clinical trial. Patients will be randomized to treatment with RPR109881 (test arm) or capecitabine (comparator arm). Patients will be stratified based on the treatment setting of prior taxane administration, prior taxane responsiveness, and region. Patients will continue to receive treatment until disease progression, patient intolerance, or withdrawal of consent. Patients who discontinue study treatment prior to disease progression will continue to have tumor assessments every 6 weeks until disease progression. Following disease progression, patients will be treated by their physicians as determined by usual medical practice and followed for survival. Patients treated on the capecitabine arm will not be eligible to receive RPR109881 in this or other clinical trials for breast cancer.

Data Summary

Datasets contain the 217 de-identified subjects assigned to the control arm. Demographic, baseline information, safety, efficacy datasets, medication, dosing and quality of life datasets were included amongst others. Source data is raw data.

Study Objectives

The primary objective of this study is to compare progression free survival (PFS) in patients with metastatic breast cancer treated with RPR109881 versus capecitabine, progressing after taxanes and anthracycline therapy,when treated with larotaxel versus capecitabine. The secondary objectives are to compare survival and other measures of anti-tumor efficacy [response rate (RR), time to tumor response (TTR), duration of response (DR), single time progression rate (STPR), and time to treatment failure (TTF)] in patients treated with RPR109881 versus capecitabine; to compare the safety and tolerability of RPR109881 versus capecitabine; and to compare the quality of life and other clinical benefit measures in patients treated with RPR109881 versus capecitabine.

Outcome Measures

The primary efficacy variable was progression free survival (PFS), based on Independent Review Committee (IRC) analysis, which was defined as the time from randomization to first documentation of RECIST-defined objective tumor progression or death due to any cause. The secondary efficacy variables included overall survival (OS), single time progression rate (STPR), and response rate (RR). Other efficacy variables were time to tumor response (TTR), time to treatment failure (TTF), and duration of response (DR). Safety parameters were adverse events, hematology, blood chemistry, vital signs, physical examinations, and ECOG performance status. Special safety parameters included febrile neutropenia, infection with neutropenia, septic death, sensory neuropathy, diarrhea, hand-foot syndrome, and fluid retention.

Available Downloads:

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

PROTOCOL: sanofi_XRP9881_EFC6089_CRF_redacted.pdf

CRF: sanofi_XRP9881_EFC6089_Protocol_Redacted.pdf

DATA DICTIONARY: sanofi_XRP9881_EFC6089_datasphere_data_definition.xls

DATA (COMPARATOR ARM): sanofi_xrp9881_efc6089_datasets_and readme.zip