NCT01907529

A Trail of Neoadjuvant Endostar in Combination With Chemotherapy in Breast Cancer

A Trail of Neoadjuvant Endostar in Combination With Docetaxel, Epirubicin and Cyclophosphamide in Patients With Stage III Breast Cancer (TENDENCY)

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Hebei Medical University Fourth Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The trial was designed to study the efficacy and safety of neoadjuvant docetaxel, epirubicin in combination with cyclophosphamide(DEC) plus human recombinant endostatin (endostar) for breast cancer patients. The hypothesis of this protocol is that the combined an active angiogenesis agent to chemotherapy could enhance the pathological responce rate and further benefit breast cancer patients.

Conditions

• Stage III Breast Cancer

Interventions

Type	Name	Description
DRUG	docetaxel, epirubicin and cyclophosphamide	docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, cyclophosphamide 500mg/m2, IV (in the vein) on day 1 of each 21 day cycle; totally 4 cycles
DRUG	docetaxel, epirubicin and cyclophosphamide plus endostar	docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, cyclophosphamide 500mg/m2, IV (in the vein) on day 1 of each 21 day cycle; endostar 7.5mg/m2, IV (in the vein) from day 1 to day 14, totally 4 cycles

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-08-01
• Completion: 2021-12-01
• First posted: 2013-07-25
• Last updated: 2019-08-09

Locations

1 site across 1 country: China