A Phase 2 interventional study of Endostar and Chemotherapy in Breast Cancer, sponsored by Zhejiang Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-04-08.
Sponsored by Zhejiang Cancer Hospital · Phase 2, Interventional, and Treatment
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Zhejiang Cancer Hospital is the lead sponsor of 281 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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.
Drug: Endostar · Drug: Chemotherapy
an anti-angiogenesis drug
Also known as: Recombinant human endostatin
Physician's choice
Progression-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
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2016 (actual). Primary completion is estimated for Dec 2019, 42 months after the start.
Of 983 non-industry phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 85. This study's planned 42 months is below that.
Counting every sponsor, half of 1,201 studies reached it within 49 months; a quarter within 31 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Endostar protein