DRUG
Dalpiciclib
an oral cyclin-dependent kinases (CDK) 4/6 inhibitor
Status
Recruiting
Phase
Phase 2
Enrollment
716
Locations
1
Results
Not posted
Publications
1
Study 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.
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.
Interventions
DRUG
an oral cyclin-dependent kinases (CDK) 4/6 inhibitor
DRUG
an irreversible dual pan-erbb receptor tyrosine kinase receptor tyrosine kinase (ERBB) inhibitor
DRUG
an anti-HER2 antibody-drug conjugate (ADC)
DRUG
an anti-programmed death ligand 1 (PD-L1) antibody
DRUG
an anti-programmed death-1 (PD1) antibody
DRUG
Trophoblast cell-surface antigen 2 (TROP2) ADC
DRUG
Pertuzumab
DRUG
Trastuzumab
DRUG
goserelin
DRUG
letrozole
DRUG
Albumin paclitaxel
DRUG
Carboplatin
Timeline
First posted
Oct 17, 2022
Study start
Nov 1, 2022
Primary completion
Dec 31, 2027
Study completion
Sep 2029
Results posted
Not reported
Registry updated
May 28, 2026
Outcomes
Pathological complete response rate (pCR)
Time frame · through study completion, up to 24 weeks
Pathological complete response rate
invasive disease-free survival (iDFS)
Time frame · Three-year Post-surgery Follow-up
To determine three-year invasive disease-free survival (iDFS) among the treatment arms
Overall response rate (ORR)
Time frame · up to 24 weeks
Complete response (CR) + partial response (PR)
CTCAE scale (V4.0)
Time frame · through study completion, an average of 1 year
4\) To evaluate the rate of adverse effects of patient by the standard CTCAE scale (V4.0)
Evaluate gene expression profile during treatment
Time frame · through study completion, up to 24 weeks
To measure gene expression profile of baseline and sequential tumor samples during treatment, through RNA-seq platform
Number of peripheral blood mononuclear cells (PBMC) count during treatment
Time frame · through study completion, up to 24 weeks
To measure number of peripheral blood mononuclear cells (PBMC) count from baseline and sequential blood samples during treatment, through Flow CytoMetry platform
Eligibility
Inclusion Criteria: * Histologically confirmed invasive breast cancer of clinical stage T1-4N1-3M0 or cT2-4N0M0; * 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 Criteria: * 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.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Fudan University Shanghai Cancer Center Shanghai, China, 200032
Shanghai, Shanghai Municipality, China
Publications
Related trials
National Cancer Institute (NCI) · Anatomic Stage III Breast Cancer AJCC v8 · Anatomic Stage IV Breast Cancer AJCC v8
Phase 3
Active, not recruiting
608
2026-07
ECOG-ACRIN Cancer Research Group · Prostate Carcinoma
Phase 3
Active, not recruiting
27
2026-07
RenJi Hospital · Prostate Cancer · Prostate
Phase 2
Not yet recruiting
200
2026-07
Washington University School of Medicine · Breast Cancer · Cancer of Breast
Phase 2
Recruiting
50
2026-07
Aristotle University Of Thessaloniki · Metabolic Dysfunction-Associated Steatotic Liver Disease · Nonalcoholic Fatty Liver
Phase 4
Active, not recruiting
62
2026-07
Mayo Clinic · Recurrent Castration-Sensitive Prostate Carcinoma · Recurrent Prostate Cancer
Phase 2
Recruiting
532
2026-07
Novartis · Early Breast Cancer
Phase 3
Recruiting
1,400
2026-07
Eli Lilly · Breast Neoplasms
Phase 2
Recruiting
600
2026-07
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.