Observation Only Study Involving Participants Enrolled in the CHAT Trial

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Contact Asia Pacific
ClinicalTrials.gov Identifier:
NCT01038466
First received: September 10, 2009
Last updated: December 22, 2009
Last verified: September 2009
  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
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

Resource links provided by NLM:


Further study details as provided by Contact Asia Pacific:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
CHAT trial participants
CHAT trial participants whose data was used in the final data analysis for the CHAT study

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
Study Population

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038466

Locations
Australia, Victoria
CONTACT Asia Pacific
Geelong, Victoria, Australia, 3220
Sponsors and Collaborators
Contact Asia Pacific
Investigators
Principal Investigator: Richard Bell, MBBS Contact Asia Pacific
  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 April 17, 2014