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NCT01907529 Clinical Trial

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

Stage III Breast Cancer Clinical Trial

— TENDENCY  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01907529
Other study ID # HBMUFH-101
Secondary ID
Status Enrolling by invitation
Phase Phase 2/Phase 3
First received
Last updated
Start date August 2019
Est. completion date December 2021

Study information
Verified date August 2019
Source Hebei Medical University Fourth Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 300
Est. completion date December 2021
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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
• 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

Locations
Country Name City State
China Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province, China Shijiazhuang Hebei

Sponsors (1)
Lead Sponsor Collaborator
Hebei Medical University Fourth Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical/pathological response The clincial response will be evaluated according to RECIST criteria. 48 months
Secondary PFS 5 years
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