NCT05749588

FUSCC Refractory TNBC Platform Study (FUTURE2.0)

Precision Platform Study of Refractory Triple-negative Breast Cancer Based on Molecular Subtyping（(A Phase II, Open-label, Single-center Platform Study）

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, open-label, Single-center platform study research based on molecular subtypes to explore precision therapy in refractory triple-negative breast cancer.

Detailed description

This is a Phase II, open-label, Single-center platform study，Based on FUSCC four TNBC subtypes and the results of the previous FUTURE trial, the investigators designed this platform trial, which for combined the TNBC subtyping and genomic sequencing-guided precision targeted therapy for refractory metastatic TNBC patients. In this trial, refractory mTNBC patients eligible for inclusion can be divided into various precision treatment group according to molecular typing and subtyping to evaluate the efficacy and safety of multiple precision targeted treatment. The research therapy arm can be updated with the update of basic translational research in our center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs.

Conditions

• Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	A1: SHR-A1811	A1: an anti-HER2 antibody-drug conjugate (ADC)
DRUG	A2: SHR-A1811 with Camrelizumab with famitinib	A2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC) Camrelizumab: an anti-programmed death-1 (PD-1) antibody
DRUG	B1: TROP2 ADC	B1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
DRUG	B2: TROP2 ADC with Camrelizumab	B2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC Camrelizumab: an anti-programmed death-1 (PD-1) antibody
DRUG	C1: SHR-A1811	C1: an anti-HER2 antibody-drug conjugate (ADC)
DRUG	C2: SHR-A1811 with BP102	C2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC) BP102: a humanized recombinant monoclonal IgG1 antibody (biosimilar to bevacizumab)
DRUG	D1: TROP2 ADC	D1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
DRUG	D2: TROP2 ADC with BP102	D2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC BP102: a humanized recombinant monoclonal IgG1 antibody (biosimilar to bevacizumab)
DRUG	E1: SHR-A1811	E1: an anti-HER2 antibody-drug conjugate (ADC)
DRUG	F1: TROP2 ADC	F1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
DRUG	G1: SHR-A1811	G1: an anti-HER2 antibody-drug conjugate (ADC)
DRUG	H1: TROP2 ADC	H1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
DRUG	E2: SHR-A1811 with everolimus	E1: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC) everolimus： an mTOR inhibitor
DRUG	TQB2102 with TQB2868	TQB2102: an anti-HER2 antibody-drug conjugate (ADC) TQB2868: an anti-PD-1/TGF-β bispecific antibody in all-comer TNBC

Timeline

• Start date: 2023-03-30
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2023-03-01
• Last updated: 2026-04-16

Locations

1 site across 1 country: China