RecruitingPhase 3NCT05806060

Precise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer

Precise Treatment for BLIS Subtype of Triple-negative Breast Cancer in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer

Sponsor

Fudan University

Enrollment

134 participants

Start Date

Apr 25, 2023

Study Type

INTERVENTIONAL

Conditions

Triple-Negative Breast Cancer

Summary

The study is being conducted to evaluate VEGFR BP102 with nab-paclitaxe or treatment of physician's choice (TPC) versus nab-paclitaxe or TPC in patients for basal-like immune suppressed (BLIS) subtype of triple-negative breast cancer (TNBC) in the first-line teatment of unresectable locally advanced or metastatic TNBC.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new first-line treatment for people with a specific type of aggressive breast cancer called triple-negative breast cancer (TNBC) with a "BLIS" subtype — meaning the cancer lacks estrogen, progesterone, and HER2 receptors and fits a particular molecular profile. Researchers want to see how well this treatment controls the cancer. **You may be eligible if...** - You have locally advanced or metastatic triple-negative breast cancer confirmed by biopsy, with the BLIS subtype - You have not previously received chemotherapy or targeted therapy for metastatic disease - You are in reasonably good physical health (able to carry out light activities) - You have a life expectancy of at least 3 months - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You have already received chemo or targeted therapy for metastatic TNBC - You are in poor overall physical health - You do not have the BLIS subtype of TNBC Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVEGFR and TPC

VEGFR and TPC If patients were de novo or their disease-free interval (DFI) were more than or equal to 12 months and were randomized to experimental arm: VEGFR bevacizumab 10mg/kg d1,15 ivgtt + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine with bevacizumab maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks and bevacizumab 10mg/kg d1,15 ivgtt every 4 weeks. If patients' DFI were less than 12 months and were randomized to experimental arm: VEGFR bevacizumab 10mg/kg d1,15 ivgtt, every 4 weeks, + TPC (eribulin mesylate 1.4mg/m2 d1,8 iv, every 3 weeks / vinorelbine 25 mg/m2 d1,8 ivgtt , every 3 weeks/ capecitabine 1000mg/m2 po bid d1-d14 every 3 weeks /carboplatin AUC=6 d1 ivgtt, every 3 weeks / UTD1 30mg/m2 d1-5 ivgtt, every 3 weeks ).

DRUGTPC

If patients were de novo or their disease-free interval (DFI) were more than or equal to 12 months and were randomized to control arm: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks. If patients' DFI were less than 12 months and were randomized to control arm: TPC (eribulin mesylate 1.4mg/m2 d1,8 iv, every 3 weeks / vinorelbine 25 mg/m2 d1,8 ivgtt , every 3 weeks/ capecitabine 1000mg/m2 po bid d1-d14 every 3 weeks /carboplatin AUC=6 d1 ivgtt, every 3 weeks / UTD1 30mg/m2 d1-5 ivgtt, every 3 weeks ).

Locations(1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

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NCT05806060

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