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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01291667

Acronym

HOPES

Enrollment

330

Registered

2011-02-08

Start date

2009-05-31

Completion date

Unknown

Last updated

2011-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Events, Overall Response Rate, Progress-free Survival

Brief 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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
progress-free survival	—

Secondary

Measure	Time frame
overall response rate,safety	—

Outcome results