Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
NCT05582499 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 716
Last updated 2025-08-22
Summary
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.
Conditions
- Breast Neoplasm
- Breast Cancer
- Breast Tumors
- Triple-Negative Breast Cancer (TNBC)
- HER2-positive Breast Cancer
- HER2-negative Breast Cancer
- Hormone Receptor Positive Tumor
- Hormone Receptor Negative Tumor
- Early-stage Breast Cancer
- Locally Advanced Breast Cancer
Interventions
- DRUG
-
Dalpiciclib
an oral cyclin-dependent kinases (CDK) 4/6 inhibitor
- DRUG
-
Pyrotinib
an irreversible dual pan-erbb receptor tyrosine kinase receptor tyrosine kinase (ERBB) inhibitor
- DRUG
-
SHR-A1811
an anti-HER2 antibody-drug conjugate (ADC)
- DRUG
-
SHR-1316
an anti-programmed death ligand 1 (PD-L1) antibody
- DRUG
-
Camrelizumab
an anti-programmed death-1 (PD1) antibody
- DRUG
-
SHR-A1921
Trophoblast cell-surface antigen 2 (TROP2) ADC
- DRUG
-
Pertuzumab
- DRUG
-
Trastuzumab
- DRUG
-
Goserelin
goserelin
- DRUG
-
letrozole
- DRUG
-
Nab paclitaxel
Albumin paclitaxel
- DRUG
-
Carboplatin
- DRUG
-
Epirubicin
Epirubicin
- DRUG
-
Cyclophosphamide
- DRUG
-
Fluzoparib
an original poly adenosine diphosphate-ribose polymerase (PARP) inhibitor
- DRUG
-
Apatinib
tyrosine kinase inhibitors
- DRUG
-
Famitinib
tyrosine kinase inhibitors
- DRUG
-
HB1801
Albumin docetaxel
- DRUG
-
LEM
liposome-entrapped mitoxantrone
- DRUG
-
TQB2102
an anti-HER2 ADC
- DRUG
-
Benmelstobart
an anti-PDL1 antibody
- DRUG
-
an tyrosine kinase inhibitor
- DRUG
-
TQB2868
anti-PD-1/TGF-βRII
- DRUG
-
an anti-PD-1/VEGF bispecific antibody
- DRUG
-
JS207
an anti-PD-1/VEGF bispecific antibody
- DRUG
-
an anti-HER2 ADC
- DRUG
-
HRS-4508
an HER2 inhibitor
- DRUG
-
SHR-4602
an anti-HER2 ADC
- DRUG
-
paclitaxel
Sponsors & Collaborators
-
Fudan University
lead OTHER
Principal Investigators
-
Zhimin Shao, Professor · Fudan University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-01
- Primary Completion
- 2026-12-31
- Completion
- 2028-09-30
Countries
- China
Study Locations
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