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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


N/A
N/A
N/A
Open (Enrolling by invite only)
Female
Breast Cancer

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Trial Information

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 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.


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- Any patients who have withdrawn consent to the CHAT study

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

The primary endpoints are Time-to-Progression and Overall Survival in the two treatment arms of the CHAT study.

Outcome Time Frame:

survival

Safety Issue:

No

Principal Investigator

Richard Bell, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Contact Asia Pacific

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

CB.0901

NCT ID:

NCT01038466

Start Date:

March 2009

Completion Date:

November 2009

Related Keywords:

  • Breast Cancer
  • CHAT
  • breast cancer
  • non interventional observational study
  • Breast Neoplasms

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