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

• Status: Enrolling by invitation
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hebei Medical University Fourth Hospital
• Treatments: Cyclophosphamide; Docetaxel; Endostar protein; Epirubicin

Criteria

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