Clinical Trials Logo
  1. Home
  2. Adverse Events
  3. NCT01291667
  4. Details
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
See also
  Status Clinical Trial Phase
Recruiting NCT05390125 - Effectiveness of a Proficiency-based Progression Communication Training Programme
Completed NCT04012320 - Efficacy and Safety on the Use of Bisphosphonates in Paediatrics
Completed NCT02268331 - Comparison of Active vs. Passive Surveillance to Collect Adverse Events N/A
Completed NCT00244673 - Randomized Study of Not Giving Diphteria-tetanus-pertussis Vaccination With or After Measles Vaccination Phase 4
Recruiting NCT05038527 - ABM/P-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery N/A
Completed NCT00681395 - Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium Phase 1
Completed NCT05359666 - Retrospective Independent Safety Review of Closed Irrisept Study N/A
Recruiting NCT05311579 - Niraparib Plus Anlotinib for Recurrent Ovarian Cancer Phase 2
Recruiting NCT05310344 - Albumin-bound Paclitaxel and Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer Phase 2
Recruiting NCT05311566 - PD-1 Antibody Plus Chemoradiotherapy for IB2-IIIB Cervical Cancer Phase 2
Completed NCT05815615 - Plasmapheresis: a Multi-modal Approach N/A
Completed NCT02130570 - Relative Patient Benefits of a Hospital-PCMH Collaboration Within an ACO to Improve Care Transitions N/A
Recruiting NCT05804188 - CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation
Not yet recruiting NCT06117176 - Prospective Assessment Project of AirwaY Management-related Incidents in Adult Anaesthesia Care PAPAYA III
Recruiting NCT02725073 - Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma Phase 2
Completed NCT02928705 - Quality of Telemedically Guided Prehospital Analgesia N/A
Withdrawn NCT01128127 - Strategies for Improving Proton Pump Inhibitors (PPIs) Prescription Associated to Non-steroidal Anti-inflammatory Drugs (NSAIDs) N/A
Terminated NCT02011607 - Incidence of Adverse Airway Events in High Risk Patients Undergoing Upper GI Endoscopy Under Anesthesia
Completed NCT02310815 - ReSure Sealant Post Approval Study N/A
Recruiting NCT05709392 - Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact: PreDECESS N/A