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

February 7, 2011 updated by: Shanghai CP Guojian Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

330

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

HER2-positive metastatic breast cancer patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
progress-free survival

Secondary Outcome Measures

Outcome Measure
overall response rate,safety

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai CP Guojian Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Study Registration Dates

First Submitted

February 6, 2011

First Submitted That Met QC Criteria

February 7, 2011

First Posted (Estimate)

February 8, 2011

Study Record Updates

Last Update Posted (Estimate)

February 8, 2011

Last Update Submitted That Met QC Criteria

February 7, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • HOPES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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