FUSCC Refractory TNBC Platform Study (FUTURE2.0)

Sponsor
Fudan University
Study ID
NCT05749588
Phase
PHASE2
Status
Recruiting
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Conditions

  • Triple-negative Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 30, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IM/HER2-low
    If patients were triple-negative breast cancer with IM subtype and HER2-low-positive
  • Experimental: IM/HER2-0
    If patients were triple-negative breast cancer with IM subtype and HER2-zero
  • Experimental: BLIS / HER2-low
    If patients were triple-negative breast cancer with BLIS subtype and HER2-low-positive
  • Experimental: BLIS /HER2-0
    If patients were triple-negative breast cancer with BLIS subtype and HER2-zero
  • Experimental: LAR / HER2-low
    If patients were triple-negative breast cancer with LAR subtype and HER2-low-positive
  • Experimental: LAR /HER2-0
    If patients were triple-negative breast cancer with LAR subtype and HER2-zero
  • Experimental: MES/ HER2-low
    If patients were triple-negative breast cancer with MES subtype and HER2-low-positive
  • Experimental: MES /HER2-0
    If patients were triple-negative breast cancer with MES subtype and HER2-zero
  • Experimental: All-Comer/TQB2102 plus TQB2868

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study (approximately 3 years) ]

Central Contacts

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