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A Phase III Randomized Study for HER2-Overexpressed Metastatic Breast Cancer Patients Treated by Trastuzumab( CipterbinĀ®) Plus vinorelbinE Simultaneously or Sequencely


Phase 3
18 Years
70 Years
Not Enrolling
Both
Progress-free Survival, Overall Response Rate, Adverse Events

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Trial Information

A Phase III Randomized Study for HER2-Overexpressed Metastatic Breast Cancer Patients Treated by Trastuzumab( CipterbinĀ®) Plus vinorelbinE Simultaneously or Sequencely


Inclusion Criteria:



- signed ICF

- pathologic diagnosis breast cancer

- HER2+ status defined as IHC3+ Staining or in situ hybridization positive at least 1
measurable lesion as per RECIST criteria age from 18y to 70y KPS>=70

Exclusion Criteria:

- More than three prior chemotherapy lines for advanced disease LVEF<50%

- prior exposure vinorebine for breast cancer

- prior exposure Trastuzumab for breast cancer

- uncontrolled brain metastasis

- breastfeeding or pregnant

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

progress-free survival

Authority:

China: Food and Drug Administration

Study ID:

HOPES

NCT ID:

NCT01291667

Start Date:

May 2009

Completion Date:

Related Keywords:

  • Progress-free Survival
  • Overall Response Rate
  • Adverse Events

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