CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 716 target
Drug / intervention
Dalpiciclib +32 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05582499
NCT05582499Phase 2RecruitingOn Track
Long Recruiting

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

Fudan University·interventional·Posted Oct 17, 2022·Updated May 28, 2026

In Brief

A Phase 2 clinical trial evaluating Dalpiciclib, Pyrotinib, and 31 other interventions for Breast Neoplasm and 9 related conditions. Currently recruiting, targeting 716 participants across 1 site.

Detailed 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.

Study Details

Timeline

Phase 2Recruiting
2023202420252026202720282029
First PostedOct 17, 2022
Enrollment StartNov 1, 2022
Primary CompletionDec 31, 2027
Study CompletionSep 1, 2029
TodayJul 1, 2026
Enrollment to primary: 5.2 yearsPosted 3.7 years agoPrimary completion in 1.5 years

Interventions

Dalpiciclibdrug

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

Pyrotinibdrug

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

SHR-A1811drug

an anti-HER2 antibody-drug conjugate (ADC)

SHR-1316drug

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

Camrelizumabdrug

an anti-programmed death-1 (PD1) antibody

SHR-A1921drug

Trophoblast cell-surface antigen 2 (TROP2) ADC

Pertuzumabdrug

Pertuzumab

Trastuzumabdrug

Trastuzumab

Goserelindrug

goserelin

Letrozoledrug

letrozole

Nab paclitaxeldrug

Albumin paclitaxel

Carboplatindrug

Carboplatin

Epirubicindrug

Epirubicin

Cyclophosphamidedrug

Cyclophosphamide

Fluzoparibdrug

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

Apatinibdrug

tyrosine kinase inhibitors

Famitinibdrug

tyrosine kinase inhibitors

HB1801drug

Albumin docetaxel

LEMdrug

liposome-entrapped mitoxantrone

TQB2102drug

an anti-HER2 ADC

Benmelstobartdrug

an anti-PDL1 antibody

Anlotinibdrug

an tyrosine kinase inhibitor

TQB2868drug

anti-PD-1/TGF-βRII

Ivonescimabdrug

an anti-PD-1/VEGF bispecific antibody

JS207drug

an anti-PD-1/VEGF bispecific antibody

JSKN003drug

an anti-HER2 ADC

HRS-4508drug

an HER2 inhibitor

SHR-4602drug

an anti-HER2 ADC

paclitaxeldrug

paclitaxel

HRS-6209drug

an oral cyclin-dependent kinases 4 (CDK4) inhibitor

9MW2821drug

a Nectin-4 antibody-drug conjugate (ADC)

IBI354drug

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.