Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01038466




Registration number
NCT01038466
Ethics application status
Date submitted
10/09/2009
Date registered
24/12/2009
Date last updated
24/12/2009

Titles & IDs
Public title
Observation Only Study Involving Participants Enrolled in the CHAT Trial
Scientific 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
Secondary ID [1] 0 0
CB.0901
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
CHAT trial participants - CHAT trial participants whose data was used in the final data analysis for the CHAT study
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary endpoints are Time-to-Progression and Overall Survival in the two treatment arms of the CHAT study.
Timepoint [1] 0 0
survival
Secondary outcome [1] 0 0
Progression-Free-Survival
Timepoint [1] 0 0
7 years
Secondary outcome [2] 0 0
Overall Survival
Timepoint [2] 0 0
7 years
Secondary outcome [3] 0 0
Anatomical sites of progression
Timepoint [3] 0 0
7 years

Eligibility
Key inclusion criteria
- CHAT trial participants whose data was used in the final data analysis for the CHAT
study
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any patients who have withdrawn consent to the CHAT study

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2009
Actual
Sample size
Target
Accrual to date
Final
222
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
CONTACT Asia Pacific - Geelong
Recruitment postcode(s) [1] 0 0
3220 - Geelong

Funding & Sponsors
Primary sponsor type
Other
Name
Contact Asia Pacific
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT01038466
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard Bell, MBBS
Address 0 0
Contact Asia Pacific
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01038466