Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy

Sponsor
Fudan University
Study ID
NCT05582499
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Dalpiciclib — DRUG
    an oral cyclin-dependent kinases (CDK) 4/6 inhibitor
  • Pyrotinib — DRUG
    an irreversible dual pan-erbb receptor tyrosine kinase receptor tyrosine kinase (ERBB) inhibitor
  • SHR-A1811 — DRUG
    an anti-HER2 antibody-drug conjugate (ADC)
  • SHR-1316 — DRUG
    an anti-programmed death ligand 1 (PD-L1) antibody
  • Camrelizumab — DRUG
    an anti-programmed death-1 (PD1) antibody
  • SHR-A1921 — DRUG
    Trophoblast cell-surface antigen 2 (TROP2) ADC
  • Pertuzumab — DRUG
    Pertuzumab
  • Trastuzumab — DRUG
    Trastuzumab
  • Goserelin — DRUG
    goserelin
  • Letrozole — DRUG
    letrozole
  • Nab paclitaxel — DRUG
    Albumin paclitaxel
  • Carboplatin — DRUG
    Carboplatin
  • Epirubicin — DRUG
    Epirubicin
  • Cyclophosphamide — DRUG
    Cyclophosphamide
  • Fluzoparib — DRUG
    an original poly adenosine diphosphate-ribose polymerase (PARP) inhibitor
  • Apatinib — DRUG
    tyrosine kinase inhibitors
  • Famitinib — DRUG
    tyrosine kinase inhibitors
  • HB1801 — DRUG
    Albumin docetaxel
  • LEM — DRUG
    liposome-entrapped mitoxantrone
  • TQB2102 — DRUG
    an anti-HER2 ADC
  • Benmelstobart — DRUG
    an anti-PDL1 antibody
  • Anlotinib — DRUG
    an tyrosine kinase inhibitor
  • TQB2868 — DRUG
    anti-PD-1/TGF-βRII
  • Ivonescimab — DRUG
    an anti-PD-1/VEGF bispecific antibody
  • JS207 — DRUG
    an anti-PD-1/VEGF bispecific antibody
  • JSKN003 — DRUG
    an anti-HER2 ADC
  • HRS-4508 — DRUG
    an HER2 inhibitor
  • SHR-4602 — DRUG
    an anti-HER2 ADC
  • paclitaxel — DRUG
    paclitaxel
  • HRS-6209 — DRUG
    an oral cyclin-dependent kinases 4 (CDK4) inhibitor
  • 9MW2821 — DRUG
    a Nectin-4 antibody-drug conjugate (ADC)
  • IBI354 — DRUG
    an anti-HER2 ADC
  • Stereotactic Body Radiation Therapy (SBRT) — RADIATION
    Stereotactic Body Radiation Therapy (SBRT) is performed within 5 calendar days prior to the initiation of drug therapy. SBRT is delivered to the primary tumor in 3 fractions of 8 Gy each (total 24 Gy) over 3-5 days.

Study Details

The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for neoadjuvant chemotherapy and by the update of basic translational research in the center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs, verified the effectiveness of new targeted drugs in neoadjuvant therapy.

Key Dates

Start date
Nov 1, 2022
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Sep 30, 2029

Study Design

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

Arms

  • Experimental: L1-1
    If patients were hormone receptor-positive (HR+) and HER2-negative (HER2-) defined as similarity network fusion 1(SNF1) subtype
  • Active Comparator: L1-2
    If patients were HR+HER2- with SNF1 subtype
  • Active Comparator: L2-2
    If patients were HR+HER2- with SNF2 subtype
  • Active Comparator: L3-2
    If patients were HR+HER2- with SNF3 subtype
  • Active Comparator: L4-2
    If patients were HR+HER2- with SNF4 subtype
  • Experimental: L4-low-1
    If patients were HR+HER2-low with SNF4 subtype
  • Active Comparator: L4-low-2
    If patients were HR+HER2-low with SNF4 subtype
  • Experimental: TN1-1
    If patients were triple-negative breast cancer with immunomodulatory (IM) subtype
  • Active Comparator: TN1-2
    If patients were triple-negative breast cancer with IM subtype
  • Experimental: TN2-1
    If patients were triple-negative breast cancer with basal-like immune suppressed (BLIS) subtype
  • Active Comparator: TN2-2
    If patients were triple-negative breast cancer with BLIS subtype
  • Experimental: TN3-1
    If patients were triple-negative breast cancer with androgen receptor positive HER2 activated (AR HER2) subtype
  • Active Comparator: TN3-2
    If patients were triple-negative breast cancer with AR HER2 subtype
  • Experimental: TN4-1.1
    If patients were HR-HER2-low
  • Active Comparator: TN4-2
    If patients were HR-HER2-low
  • Experimental: TN5-1.1
    If patients were triple-negative breast cancer with other subtypes
  • Active Comparator: TN5-2
    If patients were triple-negative breast cancer with other subtypes
  • Experimental: H1-1.1
    If patients were HR+HER2+
  • Active Comparator: H1-2
    If patients were HR+HER2+
  • Experimental: H2-1.1
    If patients were HR-HER2+
  • Active Comparator: H2-2
    If patients were HR-HER2+
  • Experimental: L2-1.2
    If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype
  • Experimental: L3-1.2
    If patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype
  • Experimental: L4-1.2
    If patients were HR+HER2- with similarity network fusion 4 (SNF4) subtype
  • Experimental: TN5-1.2
    If patients were triple-negative breast cancer with other subtypes
  • Experimental: H1-1.2
    If patients were HR+HER2+
  • Experimental: H2-1.2
    If patients were HR-HER2+
  • Experimental: TN4-1.2
    If patients were HR-HER2-low
  • Experimental: L2-1.1
    If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype
  • Experimental: L2-1.3
    If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype
  • Experimental: L3-1.1
    If patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype
  • Experimental: L4-1.1
    If patients were HR+HER2- with similarity network fusion 4 (SNF4) subtype
  • Experimental: L5-1
    If patients were HR+HER2-
  • Experimental: L5-2
    If patients were HR+HER2-
  • Experimental: L6
    If patients were HR+HER2-low
  • Experimental: L7
    If patients were HR+HER2-low
  • Experimental: L8
    If patients were HR+HER2-
  • Experimental: L9
    If patients were HR+HER2-low
  • Experimental: TN6-1
    TNBC
  • Experimental: TN6-2
    TNBC
  • Experimental: TN7-1
    If patients were HR-HER2-low
  • Experimental: TN7-2
    If patients were HR-HER2-low
  • Experimental: TN8
    TNBC
  • Experimental: TN9
    TNBC
  • Experimental: H3
    If patients were HER2+
  • Experimental: H4-1
    If patients were HER2+
  • Experimental: H4-2
    If patients were HER2+
  • Experimental: H4-3
    If patients were HER2+
  • Experimental: H4-4
    If patients were HER2+
  • Experimental: H5
    If patients were HER2+
  • Experimental: H6-1
    If patients were HER2+
  • Experimental: H6-2
    If patients were HER2+
  • Experimental: L10
    If patients were HR+HER2-
  • Experimental: H8-1
    If patients were HR+HER2+
  • Experimental: H8-2
    If patients were HR+HER2+
  • Experimental: TN10
    If patients were TNBC
  • Experimental: L11
    If patients were HR+HER2-
  • Experimental: H9
    If patients were HER2+
  • Experimental: H10
    If patients were HER2+
  • Experimental: TN6-3
    TNBC
  • Experimental: TN11-1: TNBC patients predicted sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AI
    The TN11 arm explores AI-guided multidisciplinary precision therapy in TNBC. Patients are stratified using an established digital pathology-based AI model that predicts sensitivity to the combination therapy of Paclitaxel, Carboplatin, Camrelizumab and Famitinib. Patients predicted to be sensitive (TN11-1) receive this combination therapy directly.
  • Experimental: TN11-2: TNBC patients predicted non-sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AI
    TNBC patients predicted to be non-sensitive (TN11-2) to the combination therapy of Paclitaxel, Carboplatin, Camrelizumab and Famitinib first undergo stereotactic body radiation therapy (SBRT). SBRT is delivered to the primary tumor in 3 fractions of 8 Gy (total 24 Gy) over 3-5 days. Following SBRT, patients receive the combination therapy of Paclitaxel, Carboplatin, Camrelizumab and Famitinib.
  • Experimental: L12
    Patients with HR+HER2- breast cancer, clinical stage cT1c-4, cN0-3, M0, with either tumor grade ≥2 or Ki-67 ≥20%. Patients first undergo stereotactic body radiotherapy (SBRT) to the primary tumor, followed by combination therapy of Paclitaxel + Epirubicin + Cyclophosphamide + Camrelizumab + Famitinib.

Primary Outcome Measure

Pathological complete response rate (pCR) [ Time Frame: through study completion, up to 24 weeks ]

Central Contacts

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