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
Status | Enrolling by invitation |
Enrollment | 222 |
Est. completion date | November 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - CHAT trial participants whose data was used in the final data analysis for the CHAT study Exclusion Criteria: - Any patients who have withdrawn consent to the CHAT study |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Australia | CONTACT Asia Pacific | Geelong | Victoria |
Lead Sponsor | Collaborator |
---|---|
Contact Asia Pacific |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary endpoints are Time-to-Progression and Overall Survival in the two treatment arms of the CHAT study. | survival | No | |
Secondary | Progression-Free-Survival | 7 years | No | |
Secondary | Overall Survival | 7 years | No | |
Secondary | Anatomical sites of progression | 7 years | No |
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