Breast CancerNCT01038466
Observation Only Study Involving Participants Enrolled in the CHAT Trial
An observational study of Breast Cancer, run by Contact Asia Pacific at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 222 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2009to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- CHAT trial participants whose data was used in the final data analysis for the CHAT study
Who cannot join
- Any patients who have withdrawn consent to the CHAT study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- CHAT, breast cancer, non interventional observational study
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CHAT trial participants | CHAT trial participants whose data was used in the final data analysis for the CHAT study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoints are Time-to-Progression and Overall Survival in the two treatment arms of the CHAT study.
Measured: survival
Secondary outcomes (3)
Progression-Free-Survival
Measured: 7 years
Overall Survival
Measured: 7 years
Anatomical sites of progression
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2009 (estimated)
- Study completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contact Asia Pacific
- Sponsor type
- Research network
- Investigators
- Richard Bell, MBBS, Principal investigator, Contact Asia Pacific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038466
- Sponsor's protocol ID
- CB.0901
- Status last verified
- Sep 2009
- First submitted
- 10 Sep 2009
- Last updated
- 24 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01038466
- Acronym / sponsor ID
- CB.0901
- Conditions
- Breast Cancer
- Keywords
- CHAT, breast cancer, non interventional observational study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Contact Asia PacificResearch network
- Study start
- Mar 2009
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 24 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHAT trial participants | – | –CHAT trial participants whose data was used in the final data analysis for the CHAT study |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- CHAT trial participants whose data was used in the final data analysis for the CHAT study
Key exclusion criteria (1 listed)
- Any patients who have withdrawn consent to the CHAT study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary endpoints are Time-to-Progression and Overall Survival in the two treatment arms of the CHAT study.
Time frame: survival
3 secondary outcomes
Progression-Free-Survival
Time frame: 7 years
Overall Survival
Time frame: 7 years
Anatomical sites of progression
Time frame: 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Bell, MBBS principal investigator
Contact Asia Pacific
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Contact Asia Pacific at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoints are Time-to-Progression and Overall Survival in the two treatment arms of the CHAT study. (time frame: survival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2009.