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NCT01291667 Clinical Trial

Study for HER2-Overexpressed MBC Patients Treated by Cipterbin® Plus vinorelbinE

Adverse Events Clinical Trial

— HOPES  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01291667
Other study ID # HOPES
Secondary ID
Status Completed
Phase Phase 3
First received February 6, 2011
Last updated February 7, 2011
Start date May 2009

Study information
Verified date February 2011
Source Shanghai CP Guojian Pharmaceutical Co.,Ltd.
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial Summary

Breast cancer is the most common malignant disease and the most frequent causes of cancer mortality in females worldwide. The situation is same as the world in China. Trastuzumab has been proved valuable treatment for HER2-positive breast cancer patients. Cipterbin® is developing by Shanghai CP Guojian Pharmaceutical Co.Ltd.Now we carried on the phase III trial in order to prove Cipterbin® 's efficacy and safety.

Recruitment information / eligibility
Status Completed
Enrollment 330
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shanghai CP Guojian Pharmaceutical Co.,Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary progress-free survival
Secondary overall response rate,safety
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