At a glance
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Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)
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
Interventions
an oral cyclin-dependent kinases (CDK) 4/6 inhibitor
an irreversible dual pan-erbb receptor tyrosine kinase receptor tyrosine kinase (ERBB) inhibitor
an anti-HER2 antibody-drug conjugate (ADC)
an anti-programmed death ligand 1 (PD-L1) antibody
an anti-programmed death-1 (PD1) antibody
Trophoblast cell-surface antigen 2 (TROP2) ADC
Pertuzumab
Trastuzumab
goserelin
letrozole
Albumin paclitaxel
Carboplatin
Epirubicin
Cyclophosphamide
an original poly adenosine diphosphate-ribose polymerase (PARP) inhibitor
tyrosine kinase inhibitors
tyrosine kinase inhibitors
Albumin docetaxel
liposome-entrapped mitoxantrone
an anti-HER2 ADC
an anti-PDL1 antibody
an tyrosine kinase inhibitor
anti-PD-1/TGF-βRII
an anti-PD-1/VEGF bispecific antibody
an anti-PD-1/VEGF bispecific antibody
an anti-HER2 ADC
an HER2 inhibitor
an anti-HER2 ADC
paclitaxel
an oral cyclin-dependent kinases 4 (CDK4) inhibitor
a Nectin-4 antibody-drug conjugate (ADC)
an anti-HER2 ADC
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.