Observation Only Study Involving Participants Enrolled in the CHAT Trial
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Purpose
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
| Condition |
|---|
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Breast Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| 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 primary endpoints are Time-to-Progression and Overall Survival in the two treatment arms of the CHAT study. [ Time Frame: survival ] [ Designated as safety issue: No ]
- Progression-Free-Survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- Anatomical sites of progression [ Time Frame: 7 years ] [ Designated as safety issue: No ]
| Enrollment: | 222 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | November 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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CHAT trial participants
CHAT trial participants whose data was used in the final data analysis for the CHAT study
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Detailed Description:
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
All 222 CHAT trial participants whose data was used in the final data analysis for the CHAT study will be included in the Beyond CHAT follow-up observational study
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Associate Professor Richard Bell, Contact Asia Pacific |
| ClinicalTrials.gov Identifier: | NCT01038466 History of Changes |
| Other Study ID Numbers: | CB.0901 |
| Study First Received: | September 10, 2009 |
| Last Updated: | December 22, 2009 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Contact Asia Pacific:
|
CHAT breast cancer non interventional observational study |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013