NCT05582499

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 716 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

FASCINATE-N is a platform that will compare the efficacy of novel drugs alone or in combination with standard chemotherapy with the efficacy of standard therapy alone. The goal is to identify improved treatment regimens for subsets on the basis of clinical subtyping. In this trial, breast cancer patients eligible for inclusion can be randomly divided into the precision treatment group and conventional neoadjuvant chemotherapy group according to molecular typing and subtyping. The research therapy arm can be updated with the update of basic translational research in our center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs. As described for previous adaptive trials, regimens that show to be more effective than standard therapy will graduate from the trial with their corresponding biomarker signature(s). Regimens will be dropped if they show a low probability of improved efficacy with any biomarker signature. New drugs will enter as those that have undergone testing complete their evaluation.

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

Type	Name	Description
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	Pertuzumab
DRUG	Trastuzumab	Trastuzumab
DRUG	Goserelin	goserelin
DRUG	Letrozole	letrozole
DRUG	Nab paclitaxel	Albumin paclitaxel
DRUG	Carboplatin	Carboplatin
DRUG	Epirubicin	Epirubicin
DRUG	Cyclophosphamide	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	Anlotinib	an tyrosine kinase inhibitor
DRUG	TQB2868	anti-PD-1/TGF-βRII
DRUG	Ivonescimab	an anti-PD-1/VEGF bispecific antibody
DRUG	JS207	an anti-PD-1/VEGF bispecific antibody
DRUG	JSKN003	an anti-HER2 ADC
DRUG	HRS-4508	an HER2 inhibitor
DRUG	SHR-4602	an anti-HER2 ADC
DRUG	paclitaxel	paclitaxel

Timeline

• Start date: 2022-11-01
• Primary completion: 2026-12-31
• Completion: 2028-09-01
• First posted: 2022-10-17
• Last updated: 2025-08-22

Locations

1 site across 1 country: China