Endostar in Combination With Chemotherapy in HER-2 Negative Advanced Breast Cancer
- Registration Number
- NCT03907098
- Lead Sponsor
- Zhejiang Cancer Hospital
- Brief Summary
This research study is studying endostar in combination with chemotherapy as a possible treatment for HER-2 negative advanced breast cancer.
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description endostar + chemotherapy Chemotherapy Endostar 15 mg per square of BSA, continuous intravenous infusion 24 hours a day, continuous administration for 7 days, every three weeks. Chemotherapy regimens are selected by physicians based on regular clinical decision. endostar + chemotherapy Endostar Endostar 15 mg per square of BSA, continuous intravenous infusion 24 hours a day, continuous administration for 7 days, every three weeks. Chemotherapy regimens are selected by physicians based on regular clinical decision.
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) up to approximately 100 months From enrollment to disease progression or death due to any cause
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR） up to approximately 100 months Ratio of CR and PR in all subjects
Overall Survival (OS) up to approximately 100 months From enrollment to death due to any cause
Adverse events (AEs) from enrollment to 30 days after the last dose administration Described in terms of CTC AE 4.0
Clinical Benefit Rate (CBR) up to approximately 100 months Ratio of CR,PR and SD more than or equal to 24 weeks
Trial Locations
- Locations (1)
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China