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)
Fudan University
716 participants
Nov 1, 2022
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
Inclusion Criteria11
- Histologically confirmed invasive cancer of the breast and meet the clinical stage II（T2N0-1M0/T3N0M0）or III（T2N2M0/T3N1-2M0) criteria;
- Age between18-70 years;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- ER, PR and HER2 status were measured by immunohistochemistry (IHC);
- LVEF≥55%；
- Definition of SNF subtypes: SNF subtypes confirmed by digital pathology of H\&E slices;
- Triple negative subtyping: On the basis of triple-negative pathological diagnosis, AR, cluster of differentiation 8 (CD8) and Forkhead Box C1 (FOXC1) were combined to define the subtyping;
- At least one measurable lesion according to RECIST version 1.1
- Normal organ and marrow function: Hemoglobin (HB) ≥90 g/L (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 75,000/μL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine \< 1 x ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula);
- Non-pregnant and non-lactating, fertile female subjects were required to use a medically approved contraceptive method for the duration of the study treatment and at least 3 months after the last use of the study drug;
- Ability to understand and willingness to sign a written informed consent
Exclusion Criteria8
- Previous cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;
- Patients with New York Heart Association (NYHA) grade II or above heart disease (including grade II);
- Patients with severe systemic infections or other serious diseases;
- Patients with known allergy or intolerance to the study drug or its excipients;
- Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer;
- Pregnant or lactating patients of childbearing age who refused to take appropriate contraceptive measures during the course of the study;
- Participated in other trial studies within 30 days before the administration of the first dose of the study drug;
- Patients who were judged by the investigator to be unsuitable for this study.
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05582499