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

Phase 2

• Conditions: Stage III Breast Cancer
• Interventions: Drug: docetaxel, epirubicin and cyclophosphamide plus endostar; Drug: docetaxel, epirubicin and cyclophosphamide

• Registration Number: NCT01907529
• Lead Sponsor: Hebei Medical University Fourth Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-22
• Study First Submitted QC: 2013-07-22
• Study First Posted: 2013-07-25
• Status Verified: 2019-08
• Study Start: 2019-08
• Last Update Submitted: 2019-08-07
• Last Update Posted: 2019-08-09
• Primary Completion: 2020-08
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis)
• Age 18-70
• No evidence of distant metastasis
• No previous therapy
• Normal hematologic function
• No abnormality of renal or liver function
• Written informed consent

Exclusion Criteria

• With allergic constitution or possible allergic reflection to drugs to be used in this study
• Any concurrent uncontrolled medical or psychiatric disorder
• History of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease
• Being pregnant or nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemo plus Endostar	docetaxel, epirubicin and cyclophosphamide plus endostar	Docetaxel, epirubicin and cyclophosphamide plus endostar
Chemo only	docetaxel, epirubicin and cyclophosphamide	docetaxel, epirubicin and cyclophosphamide

Primary Outcome Measures

Name	Time	Method
Clinical/pathological response	48 months	The clincial response will be evaluated according to RECIST criteria.

Secondary Outcome Measures

Name	Time	Method
PFS	5 years

Trial Locations

Locations (1)

Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province, China; 🇨🇳 Shijiazhuang, Hebei, China