Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
NCT ID: NCT05582499
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
716 participants
INTERVENTIONAL
2022-11-01
2028-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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L1-1
If patients were hormone receptor-positive (HR+) and HER2-negative (HER2-) defined as similarity network fusion 1(SNF1) subtype
Dalpiciclib
an oral cyclin-dependent kinases (CDK) 4/6 inhibitor
Goserelin
goserelin
Letrozole
letrozole
L1-2
If patients were HR+HER2- with SNF1 subtype
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
L2-2
If patients were HR+HER2- with SNF2 subtype
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
L3-2
If patients were HR+HER2- with SNF3 subtype
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
L4-2
If patients were HR+HER2- with SNF4 subtype
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
L4-low-1
If patients were HR+HER2-low with SNF4 subtype
SHR-A1811
an anti-HER2 antibody-drug conjugate (ADC)
L4-low-2
If patients were HR+HER2-low with SNF4 subtype
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
TN1-1
If patients were triple-negative breast cancer with immunomodulatory (IM) subtype
Camrelizumab
an anti-programmed death-1 (PD1) antibody
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
Epirubicin
Epirubicin
Cyclophosphamide
Cyclophosphamide
TN1-2
If patients were triple-negative breast cancer with IM subtype
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
Epirubicin
Epirubicin
Cyclophosphamide
Cyclophosphamide
TN2-1
If patients were triple-negative breast cancer with basal-like immune suppressed (BLIS) subtype
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
Epirubicin
Epirubicin
Cyclophosphamide
Cyclophosphamide
Fluzoparib
an original poly adenosine diphosphate-ribose polymerase (PARP) inhibitor
TN2-2
If patients were triple-negative breast cancer with BLIS subtype
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
Epirubicin
Epirubicin
Cyclophosphamide
Cyclophosphamide
TN3-1
If patients were triple-negative breast cancer with androgen receptor positive HER2 activated (AR HER2) subtype
Pyrotinib
an irreversible dual pan-erbb receptor tyrosine kinase receptor tyrosine kinase (ERBB) inhibitor
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
Epirubicin
Epirubicin
Cyclophosphamide
Cyclophosphamide
TN3-2
If patients were triple-negative breast cancer with AR HER2 subtype
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
Epirubicin
Epirubicin
Cyclophosphamide
Cyclophosphamide
TN4-1.1
If patients were HR-HER2-low
SHR-A1811
an anti-HER2 antibody-drug conjugate (ADC)
TN4-2
If patients were HR-HER2-low
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
Epirubicin
Epirubicin
Cyclophosphamide
Cyclophosphamide
TN5-1.1
If patients were triple-negative breast cancer with other subtypes
SHR-A1921
Trophoblast cell-surface antigen 2 (TROP2) ADC
TN5-2
If patients were triple-negative breast cancer with other subtypes
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
Epirubicin
Epirubicin
Cyclophosphamide
Cyclophosphamide
H1-1.1
If patients were HR+HER2+
Pyrotinib
an irreversible dual pan-erbb receptor tyrosine kinase receptor tyrosine kinase (ERBB) inhibitor
SHR-A1811
an anti-HER2 antibody-drug conjugate (ADC)
H1-2
If patients were HR+HER2+
Pertuzumab
Pertuzumab
Trastuzumab
Trastuzumab
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
H2-1.1
If patients were HR-HER2+
Pyrotinib
an irreversible dual pan-erbb receptor tyrosine kinase receptor tyrosine kinase (ERBB) inhibitor
H2-2
If patients were HR-HER2+
Pertuzumab
Pertuzumab
Trastuzumab
Trastuzumab
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
L2-1.2
If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype
SHR-1316
an anti-programmed death ligand 1 (PD-L1) antibody
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
L3-1.2
If patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
Fluzoparib
an original poly adenosine diphosphate-ribose polymerase (PARP) inhibitor
L4-1.2
If patients were HR+HER2- with similarity network fusion 4 (SNF4) subtype
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
Apatinib
tyrosine kinase inhibitors
TN5-1.2
If patients were triple-negative breast cancer with other subtypes
SHR-1316
an anti-programmed death ligand 1 (PD-L1) antibody
SHR-A1921
Trophoblast cell-surface antigen 2 (TROP2) ADC
H1-1.2
If patients were HR+HER2+
SHR-A1811
an anti-HER2 antibody-drug conjugate (ADC)
H2-1.2
If patients were HR-HER2+
Pyrotinib
an irreversible dual pan-erbb receptor tyrosine kinase receptor tyrosine kinase (ERBB) inhibitor
SHR-A1811
an anti-HER2 antibody-drug conjugate (ADC)
TN4-1.2
If patients were HR-HER2-low
SHR-A1811
an anti-HER2 antibody-drug conjugate (ADC)
Camrelizumab
an anti-programmed death-1 (PD1) antibody
Famitinib
tyrosine kinase inhibitors
L2-1.1
If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype
Dalpiciclib
an oral cyclin-dependent kinases (CDK) 4/6 inhibitor
Goserelin
goserelin
Letrozole
letrozole
L2-1.3
If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype
SHR-1316
an anti-programmed death ligand 1 (PD-L1) antibody
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
Famitinib
tyrosine kinase inhibitors
L3-1.1
If patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype
Dalpiciclib
an oral cyclin-dependent kinases (CDK) 4/6 inhibitor
Goserelin
goserelin
Letrozole
letrozole
L4-1.1
If patients were HR+HER2- with similarity network fusion 4 (SNF4) subtype
SHR-A1921
Trophoblast cell-surface antigen 2 (TROP2) ADC
L5-1
If patients were HR+HER2-
Cyclophosphamide
Cyclophosphamide
HB1801
Albumin docetaxel
LEM
liposome-entrapped mitoxantrone
L5-2
If patients were HR+HER2-
Cyclophosphamide
Cyclophosphamide
HB1801
Albumin docetaxel
LEM
liposome-entrapped mitoxantrone
L6
If patients were HR+HER2-low
SHR-A1811
an anti-HER2 antibody-drug conjugate (ADC)
SHR-1316
an anti-programmed death ligand 1 (PD-L1) antibody
Famitinib
tyrosine kinase inhibitors
L7
If patients were HR+HER2-low
Famitinib
tyrosine kinase inhibitors
TQB2102
an anti-HER2 ADC
Benmelstobart
an anti-PDL1 antibody
L8
If patients were HR+HER2-
TQB2102
an anti-HER2 ADC
Anlotinib
an tyrosine kinase inhibitor
TQB2868
anti-PD-1/TGF-βRII
L9
If patients were HR+HER2-low
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
Epirubicin
Epirubicin
Cyclophosphamide
Cyclophosphamide
Ivonescimab
an anti-PD-1/VEGF bispecific antibody
TN6-1
TNBC
SHR-A1811
an anti-HER2 antibody-drug conjugate (ADC)
SHR-1316
an anti-programmed death ligand 1 (PD-L1) antibody
Famitinib
tyrosine kinase inhibitors
TN6-2
TNBC
SHR-A1811
an anti-HER2 antibody-drug conjugate (ADC)
SHR-1316
an anti-programmed death ligand 1 (PD-L1) antibody
TN7-1
If patients were HR-HER2-low
TQB2102
an anti-HER2 ADC
Benmelstobart
an anti-PDL1 antibody
TN7-2
If patients were HR-HER2-low
TQB2102
an anti-HER2 ADC
Benmelstobart
an anti-PDL1 antibody
Anlotinib
an tyrosine kinase inhibitor
TN8
TNBC
TQB2102
an anti-HER2 ADC
TQB2868
anti-PD-1/TGF-βRII
TN9
TNBC
Carboplatin
Carboplatin
Epirubicin
Epirubicin
Cyclophosphamide
Cyclophosphamide
paclitaxel
paclitaxel
H3
If patients were HER2+
JSKN003
an anti-HER2 ADC
H4-1
If patients were HER2+
SHR-A1811
an anti-HER2 antibody-drug conjugate (ADC)
Pertuzumab
Pertuzumab
Trastuzumab
Trastuzumab
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
H4-2
If patients were HER2+
SHR-A1811
an anti-HER2 antibody-drug conjugate (ADC)
H4-3
If patients were HER2+
Pertuzumab
Pertuzumab
Trastuzumab
Trastuzumab
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
H4-4
If patients were HER2+
Pyrotinib
an irreversible dual pan-erbb receptor tyrosine kinase receptor tyrosine kinase (ERBB) inhibitor
SHR-A1811
an anti-HER2 antibody-drug conjugate (ADC)
H5
If patients were HER2+
SHR-A1811
an anti-HER2 antibody-drug conjugate (ADC)
SHR-4602
an anti-HER2 ADC
H6-1
If patients were HER2+
SHR-A1811
an anti-HER2 antibody-drug conjugate (ADC)
HRS-4508
an HER2 inhibitor
H6-2
If patients were HER2+
SHR-A1811
an anti-HER2 antibody-drug conjugate (ADC)
Pertuzumab
Pertuzumab
HRS-4508
an HER2 inhibitor
L10
If patients were HR+HER2-
Nab paclitaxel
Albumin paclitaxel
Epirubicin
Epirubicin
Cyclophosphamide
Cyclophosphamide
JS207
an anti-PD-1/VEGF bispecific antibody
Interventions
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Dalpiciclib
an oral cyclin-dependent kinases (CDK) 4/6 inhibitor
Pyrotinib
an irreversible dual pan-erbb receptor tyrosine kinase receptor tyrosine kinase (ERBB) inhibitor
SHR-A1811
an anti-HER2 antibody-drug conjugate (ADC)
SHR-1316
an anti-programmed death ligand 1 (PD-L1) antibody
Camrelizumab
an anti-programmed death-1 (PD1) antibody
SHR-A1921
Trophoblast cell-surface antigen 2 (TROP2) ADC
Pertuzumab
Pertuzumab
Trastuzumab
Trastuzumab
Goserelin
goserelin
Letrozole
letrozole
Nab paclitaxel
Albumin paclitaxel
Carboplatin
Carboplatin
Epirubicin
Epirubicin
Cyclophosphamide
Cyclophosphamide
Fluzoparib
an original poly adenosine diphosphate-ribose polymerase (PARP) inhibitor
Apatinib
tyrosine kinase inhibitors
Famitinib
tyrosine kinase inhibitors
HB1801
Albumin docetaxel
LEM
liposome-entrapped mitoxantrone
TQB2102
an anti-HER2 ADC
Benmelstobart
an anti-PDL1 antibody
Anlotinib
an tyrosine kinase inhibitor
TQB2868
anti-PD-1/TGF-βRII
Ivonescimab
an anti-PD-1/VEGF bispecific antibody
JS207
an anti-PD-1/VEGF bispecific antibody
JSKN003
an anti-HER2 ADC
HRS-4508
an HER2 inhibitor
SHR-4602
an anti-HER2 ADC
paclitaxel
paclitaxel
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age between18-70 years;
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
* ER, PR and HER2 status were measured by immunohistochemistry (IHC);
* LVEF≥55%；
* Definition of SNF subtypes: SNF subtypes confirmed by digital pathology of H\&E slices;
* Triple negative subtyping: On the basis of triple-negative pathological diagnosis, AR, cluster of differentiation 8 (CD8) and Forkhead Box C1 (FOXC1) were combined to define the subtyping;
* At least one measurable lesion according to RECIST version 1.1
* Normal organ and marrow function: Hemoglobin (HB) ≥90 g/L (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 75,000/μL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine \< 1 x ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula);
* Non-pregnant and non-lactating, fertile female subjects were required to use a medically approved contraceptive method for the duration of the study treatment and at least 3 months after the last use of the study drug;
* Ability to understand and willingness to sign a written informed consent
Exclusion Criteria
* Patients with New York Heart Association (NYHA) grade II or above heart disease (including grade II);
* Patients with severe systemic infections or other serious diseases;
* Patients with known allergy or intolerance to the study drug or its excipients;
* Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer;
* Pregnant or lactating patients of childbearing age who refused to take appropriate contraceptive measures during the course of the study;
* Participated in other trial studies within 30 days before the administration of the first dose of the study drug;
* Patients who were judged by the investigator to be unsuitable for this study.
18 Years
70 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhimin Shao
Professor
Principal Investigators
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Zhimin Shao, Professor
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center Shanghai, China, 200032
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Zuo WJ, Chen L, Shen Y, Wang ZH, Liu GY, Yu KD, Di GH, Wu J, Li JJ, Shao ZM. Rational and trial design of FASCINATE-N: a prospective, randomized, precision-based umbrella trial. Ther Adv Med Oncol. 2024 Feb 14;16:17588359231225032. doi: 10.1177/17588359231225032. eCollection 2024.
Other Identifiers
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FASCINATE-N
Identifier Type: -
Identifier Source: org_study_id
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