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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03907098
Other study ID # ZJCHBC008
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 30, 2016
Est. completion date June 30, 2020

Study information

Verified date April 2019
Source Zhejiang Cancer Hospital
Contact Xiaojia Wang, PhD
Phone 86 13906500190
Email wxiaojia0803@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research study is studying endostar in combination with chemotherapy as a possible treatment for HER-2 negative advanced breast cancer.


Description:

This is a multi-center phase II open label single-arm study to assess the safety and efficacy of endostar in combination with chemotherapy for patients with locoregionally recurrent or metastatic HER-2 negative breast cancer.

Endostar is an anti-angiogenesis drug. It is prepared by adding 9 amino acids to the N-terminal of the peptide chain on the basis of endostatin. Studies have shown that there may be a synergistic effect between endostar and chemotherapeutic agents.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 30, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- locoregionally Recurrent or metastatic breast cancer confirmed by histology.

- HER-2 Negative Breast Cancer.

- At least one measurable lesion according to RECIST 1.1..

- Chemotherapy for recurrent and metastatic lesions should be discontinued for more than 2 weeks.

- 18-70 years old.

- ECOG PS 0~1.

- Participants must have normal organ and marrow function as defined below: ANC = 1.5×109/L,PLT = 75×109/L,Hb = 100 g/L;TBIL=1.0ULN;ALT and AST=3×ULN(ALT and AST=5×ULN if liver metastasis);BUN and Cr=1.5×ULN and CCr=50 mL/min.

- life expectancy is not less than 12 weeks.

- Signed informed consent.

Exclusion Criteria:

- Uncontrolled central nervous system metastasis.

- Not recovered to 0-1 degree (CTC AE 4.0) from toxic reactions of previous treatments..

- History of allergy to biological agents in the past.

- Important organ dysfunction and severe heart disease, including congestive heart failure, uncontrollable arrhythmia, angina, valvular disease, myocardial infarction, and refractory hypertension.

- Pregnant or lactating women..

- The patient had a history of other malignant tumors, except for the cured skin basal cell carcinoma and cervical cancer.

- The risk of uncontrolled infection, thrombosis and bleeding exists.

- A history of immunodeficiency, including HIV positive, HCV, active hepatitis B, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known.

- Researchers consider it inappropriate to carry out the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Endostar
an anti-angiogenesis drug
Chemotherapy
Physician's choice

Locations

Country Name City State
China Zhejiang Cancer Hospital Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free Survival (PFS) From enrollment to disease progression or death due to any cause up to approximately 100 months
Secondary Overall Survival (OS) From enrollment to death due to any cause up to approximately 100 months
Secondary Objective Response Rate (ORR) Ratio of CR and PR in all subjects up to approximately 100 months
Secondary Clinical Benefit Rate (CBR) Ratio of CR,PR and SD more than or equal to 24 weeks up to approximately 100 months
Secondary Adverse events (AEs) Described in terms of CTC AE 4.0 from enrollment to 30 days after the last dose administration
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