SNF Platform Study of HR+/ HER2-advanced Breast Cancer

Sponsor
Fudan University
Study ID
NCT05594095
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • PIK3CA inhibitor — DRUG
    PIK3CA inhibitor
  • AKT inhibitor — DRUG
    AKT inhibitor
  • Carrelizumab — DRUG
    Pd-1 mab
  • Famitinib — DRUG
    VEGFR inhibitor
  • Fluzoparib — DRUG
    PARP inhibitor
  • Dalpiciclib — DRUG
    CDK4/6 inhibitor
  • SHR-A1811 — DRUG
    HER2 ADC
  • Everolimus — DRUG
    mTOR inhibior
  • Aromatase Inhibitors or Fulvestrant — DRUG
    Letrozole/Anastrozole/Exemestane or Fulvestrant
  • Goserelin — DRUG
    For premenopause
  • TPC — DRUG
    Treatment of Physicians' Choice (albumin-paclitaxel, capecitabine, vinorelbine, and irbribulin)
  • Sorafenib — DRUG
    RTK Inhibitor
  • Apatinib — DRUG
    Apatinib 250mg po qd
  • SHR-A1921 — DRUG
    TROP2 ADC
  • SHR-A2102 — DRUG
    NECTIN4 ADC
  • SHR-A2009 — DRUG
    HER3 ADC
  • SHR-1167 — DRUG
    PARP1i
  • SHR-6209 — DRUG
    CDK4i
  • bevacizumab — DRUG
    bevacizumab

Study Details

The purpose of this study is to establish a prospective, multi-center platform research based on clinical subtypes to explore precision therapy in patients hormone-receptor-positive HER2-negative advanced breast cancer who had previously used CDK4/6 inhibitors.

Key Dates

Start date
Dec 30, 2022
Status verified
Oct 2023
Primary completion
Dec 1, 2025
Completion
Dec 1, 2026

Study Design

Enrollment
620 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SNF1 1A: PIK3CA mutation
    PIK3CA inhibitors +Aromatase inhibitors(Letrozole/Anastrozole/Exemestane, po, qd, specific dose (letrozole 2.5mg/ day; Anastrozole 1mg/ day, Exemestane 25mg/ day);Or fulvestrant, 500mg ,im, qm, followed by 500mg im 2 weeks after the first dose; Premenopausal: Goserelin 3.6mg IM every 4 weeks.
  • Experimental: SNF1 1B: AKT pathway mutation
    AKT pathway inhibitors +Aromatase inhibitors(Letrozole/Anastrozole/Exemestane, po, qd, specific dose (letrozole 2.5mg/ day; Anastrozole 1mg/ day, Exemestane 25mg/ day);Or fulvestrant, 500mg ,im, qm, followed by 500mg im 2 weeks after the first dose; Premenopausal: Goserelin 3.6mg IM every 4 weeks.
  • Experimental: SNF1 1C: without above mutation
    Everolimus 10mg po qd+Aromatase inhibitors(Letrozole/Anastrozole/Exemestane, po, qd, specific dose (letrozole 2.5mg/ day; Anastrozole 1mg/ day, Exemestane 25mg/ day);Or fulvestrant, 500mg ,im, qm, followed by 500mg im 2 weeks after the first dose; Premenopausal: Goserelin 3.6mg IM every 4 weeks.
  • Experimental: SNF2 2A
    Treatment of physician' choice+Pd-1 mab (Carrelizumab 200mg Q2W)+Famitinib 15mg po qd for 4 weeks as a cycle
  • Experimental: SNF3 3A: Stratification of BRCA/PALB2 expression
    Fluzoparib SHR3162 100mg po qd+Dalpiciclib 125mg po qd for 4 weeks as a cycle
  • Experimental: SNF4 4A: HER2 low
    SHR-A1811
  • Active Comparator: The control arm
    Treatment of Physicians' Choice (albumin-paclitaxel, capecitabine, vinorelbine, and irbribulin)
  • Experimental: SNF3 3B:
    Fluzoparib SHR3162 100 mg qd+Treatment of physician' choice
  • Experimental: SNF4 4B:
    Apatinib 250mg qd+Treatment of physician' choice
  • Experimental: SNF1 1D: without above mutation
    Everolimus 10mg po qd+Treatment of physician' choice
  • Experimental: SNF1 1E: HER2 LOW
    Everolimus 10mg po qd+SHR-A1811
  • Experimental: SNF1 1F: HER2 zero
    Everolimus 10mg po qd+SHR-A1921
  • Experimental: SNF2 2B: HER2 zero
    SHR-A1921+Pd-1 mab (Carrelizumab 200mg Q2W)+bevacizumab 7.5mg po ivgt t for 3 weeks as a cycle
  • Experimental: SNF2 2C:
    HER3 -ADC+Pd-1 mab (Carrelizumab 200mg Q2W)+Famitinib for 3 weeks as a cycle
  • Experimental: SNF2 2D:
    Nectin4-ADC+Pd-1 mab (Carrelizumab 200mg Q2W)+Famitinib for 3 weeks as a cycle
  • Experimental: SNF2 2E: HER2 low
    SHR-A1811+Pd-1 mab (Carrelizumab 200mg Q2W)+Famitinib for 3 weeks as a cycle
  • Experimental: SNF3 3C:
    CDK4i（SHR-6209 PR2D+PARP1i（SHR-1167 PR2D）
  • Experimental: SNF3 3D:
    PARP1i（SHR-1167 PR2D)+Famitinib 5mg po qd for 4 weeks as a cycle
  • Experimental: SNF3 3E: HER2 low
    PARP1i（SHR-1167 PR2D)+SHR-A1811 for 3 weeks as a cycle
  • Experimental: SNF3 3F: HER2 zero
    PARP1i（SHR-1167 PR2D)+SHR-A1921 for 3 weeks as a cycle
  • Experimental: SNF4 4C
    Famitinib 20mg po qd
  • Experimental: SNF4 4D
    Sorafenib 0.4g bid
  • Experimental: SNF4 4E
    Apatinib 500mg qd
  • Experimental: SNF4 4F: HER2 low
    Famitinib+SHR-A1811 for 3 weeks as a cycle
  • Experimental: SNF4 4G
    Famitinib+HER3-ADC for 3 weeks as a cycle
  • Experimental: SNF4 4H
    Famitinib+Nectin4-ADC for 3 weeks as a cycle

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 end of study (approximately 3 years) ]

Central Contacts

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