Breast Cancer Clinical Trial
Official title:
Follow-Up Observational Study In CHAT Trial Participants With Advanced And/Or Metastatic Breast Cancers That Overexpress HER2, Who Were Randomised To Receive Trastuzumab And Docetaxel With Or Without Capecitabine
The aim of the CHAT study ("An open-label, randomized Phase II study of Herceptin
(trastuzumab), Taxotere® (docetaxel) and Xeloda (capecitabine) in combination, versus
Herceptin (trastuzumab) plus Taxotere® (docetaxel), in patients with advanced and/or
metastatic breast cancers that overexpress HER2") was to test the combination of Trastuzumab
and Docetaxel with or without capecitabine as first-line therapy for HER2 positive locally
advanced or metastatic breast cancer.
Overall Response Rate was the primary endpoint of the CHAT study. This study failed to meet
its primary objective of showing a difference between the treatment groups, with equivalent
high response rates for the Trastuzumab plus Docetaxel and Trastuzumab, Docetaxel plus
capecitabine arms.
Secondary endpoints in the CHAT study were Progression-Free-Survival, Time-to-Progression,
Overall Survival, duration of response and safety profile. Whilst analysis of the existing
data is consistent with improvement with the triplet therapy, interpretation is compromised
by the relatively short median follow-up of 24 months. In hindsight the statistical design
was flawed by selection of a sub optimal primary endpoint and consequently data was
collected and analysed early in relation to time-dependent endpoints. Beyond CHAT will
permit capture of mature data for time-related endpoints. Time-to-Progression and Overall
Survival are the co-primary endpoints for the Beyond CHAT protocol. The impact of treatment
following the first progression, on survival, will be explored.
Time-to-Progression will be defined from the time interval between the date of randomisation
and the occurrence of progressive disease under therapy according to RECIST criteria.
Overall Survival will be defined as the time from date of randomisation to date of death
The objective of this study is to gain mature data on the long-term efficacy of the
combination of Trastuzumab and Docetaxel with or without capecitabine as first-line therapy
for HER2 positive locally advanced or metastatic breast cancer.
The study also aims to gain information on the additional treatments and sequencing used in
patients that have progressed following the combination of Trastuzumab and Docetaxel with or
without capecitabine as first-line therapy for HER2 positive locally advanced or metastatic
breast cancer.
Overall Survival data on patients who have progressed following the combination of
Trastuzumab and Docetaxel with or without capecitabine as first-line therapy for HER2
positive locally advanced or metastatic breast cancer will also be analysed and reported.
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Observational Model: Cohort, Time Perspective: Retrospective
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