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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
716
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
Fudan University Shanghai Cancer Center Shanghai, China, 200032
Shanghai, Shanghai Municipality, China
RECRUITINGPathological complete response rate (pCR)
Pathological complete response rate
Time frame: through study completion, up to 24 weeks
invasive disease-free survival (iDFS)
To determine three-year invasive disease-free survival (iDFS) among the treatment arms
Time frame: Three-year Post-surgery Follow-up
Overall response rate (ORR)
Complete response (CR) + partial response (PR)
Time frame: up to 24 weeks
CTCAE scale (V4.0)
4\) To evaluate the rate of adverse effects of patient by the standard CTCAE scale (V4.0)
Time frame: through study completion, an average of 1 year
Evaluate gene expression profile during treatment
To measure gene expression profile of baseline and sequential tumor samples during treatment, through RNA-seq platform
Time frame: through study completion, up to 24 weeks
Number of peripheral blood mononuclear cells (PBMC) count during treatment
To measure number of peripheral blood mononuclear cells (PBMC) count from baseline and sequential blood samples during treatment, through Flow CytoMetry platform
Time frame: through study completion, up to 24 weeks
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