Study of Trastuzumab Combined With Capecitabine on HER2-positive Metastatic Breast Cancer Patients Pretreated With Trastuzumab and Taxanes or HER2- Positive Breast Cancer Patients Relapsed From (Neo)Adjuvant Therapy of Trastuzumab and Taxanes
Phase 2
18 Years
65 Years
18 Years
65 Years
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
Study of Trastuzumab Combined With Capecitabine on HER2-positive Metastatic Breast Cancer Patients Pretreated With Trastuzumab and Taxanes or HER2- Positive Breast Cancer Patients Relapsed From (Neo)Adjuvant Therapy of Trastuzumab and Taxanes
Inclusion Criteria:
- Female patients, 18-65 years of age
- Histologically confirmed HER2-positive breast cancer with measurable lesions
(according to RECIST criteria)
- Metastatic disease after first-line therapy or recurrent disease after (neo)adjuvant
therapy with Herceptin and taxanes
- ECOG performance status 0-2
Exclusion Criteria:
- CNS metastases which are not well controlled
- Simultaneous treatment with sorivudine
- History of another malignancy within the last 5 years except for cured basal cell
carcinoma of the skin and cured carcinoma in-situ of the uterine cervix
- Pregnant or lactating women
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall response rate (tumour assessments according to RECIST criteria)
Outcome Time Frame:
approximately 30 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Taiwan: Ministry of Health
Study ID:
ML21833
NCT ID:
NCT01290718
Start Date:
December 2011
Completion Date:
December 2012
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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