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

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.

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Key information

Conditions

Progress-free Survival Adverse Events Overall Response Rate

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

progress-free survival

Secondary outcomes

overall response rate,safety

Sponsors and collaborators

Lead sponsor

Shanghai CP Guojian Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: HOPES

Important dates

Study start: 2009
First posted: Feb 8, 2011
Registry last updated: Feb 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed