This research study is studying endostar in combination with chemotherapy as a possible treatment for HER-2 negative advanced breast cancer.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
an anti-angiogenesis drug
Physician's choice
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGProgression-free Survival (PFS)
From enrollment to disease progression or death due to any cause
Time frame: up to approximately 100 months
Overall Survival (OS)
From enrollment to death due to any cause
Time frame: up to approximately 100 months
Objective Response Rate (ORR)
Ratio of CR and PR in all subjects
Time frame: up to approximately 100 months
Clinical Benefit Rate (CBR)
Ratio of CR,PR and SD more than or equal to 24 weeks
Time frame: up to approximately 100 months
Adverse events (AEs)
Described in terms of CTC AE 4.0
Time frame: from enrollment to 30 days after the last dose administration
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