RecruitingPhase 2NCT05582499

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

Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)


Sponsor

Fudan University

Enrollment

716 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is researching personalized treatment approaches for breast cancer before surgery (called neoadjuvant therapy). By classifying breast cancers into specific subtypes using digital pathology, researchers aim to match each patient to the most effective pre-surgery treatment. **You may be eligible if...** - You are 18–70 years old - You have invasive breast cancer at stage II or III - You are in good physical health - Your cancer subtype (ER, PR, HER2 status) has been tested - Your heart function is normal (ejection fraction at least 55%) - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to distant organs - You are pregnant or breastfeeding - Your heart function is significantly reduced - You have previously received chemotherapy for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDalpiciclib

an oral cyclin-dependent kinases (CDK) 4/6 inhibitor

DRUGPyrotinib

an irreversible dual pan-erbb receptor tyrosine kinase receptor tyrosine kinase (ERBB) inhibitor

DRUGSHR-A1811

an anti-HER2 antibody-drug conjugate (ADC)

DRUGSHR-1316

an anti-programmed death ligand 1 (PD-L1) antibody

DRUGCamrelizumab

an anti-programmed death-1 (PD1) antibody

DRUGSHR-A1921

Trophoblast cell-surface antigen 2 (TROP2) ADC

DRUGPertuzumab

Pertuzumab

DRUGTrastuzumab

Trastuzumab

DRUGGoserelin

goserelin

DRUGLetrozole

letrozole

DRUGNab paclitaxel

Albumin paclitaxel

DRUGCarboplatin

Carboplatin

DRUGEpirubicin

Epirubicin

DRUGCyclophosphamide

Cyclophosphamide

DRUGFluzoparib

an original poly adenosine diphosphate-ribose polymerase (PARP) inhibitor

DRUGApatinib

tyrosine kinase inhibitors

DRUGFamitinib

tyrosine kinase inhibitors

DRUGHB1801

Albumin docetaxel

DRUGLEM

liposome-entrapped mitoxantrone

DRUGTQB2102

an anti-HER2 ADC

DRUGBenmelstobart

an anti-PDL1 antibody

DRUGAnlotinib

an tyrosine kinase inhibitor

DRUGTQB2868

anti-PD-1/TGF-βRII

DRUGIvonescimab

an anti-PD-1/VEGF bispecific antibody

DRUGJS207

an anti-PD-1/VEGF bispecific antibody

DRUGJSKN003

an anti-HER2 ADC

DRUGHRS-4508

an HER2 inhibitor

DRUGSHR-4602

an anti-HER2 ADC

DRUGpaclitaxel

paclitaxel


Locations(1)

Fudan University Shanghai Cancer Center Shanghai, China, 200032

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT05582499


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