← Back to results
NCT05582499PHASE2RECRUITING

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)

Sponsor: Fudan University

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

Request endpoint coverage

Key Facts

Study type
INTERVENTIONAL
Conditions
Breast Neoplasm, Breast Cancer, Breast Tumors, Triple-Negative Breast Cancer (TNBC), HER2-positive Breast Cancer
Interventions
Dalpiciclib, Pyrotinib, SHR-A1811, SHR-1316
Enrollment
716 participants
Primary completion
Dec 2027
Study completion
Sep 2029
First posted
Oct 2022
Last updated
May 2026

Primary Endpoints (CT.gov)

Pathological complete response rate (pCR)

Time frame: through study completion, up to 24 weeks

Secondary Endpoints

invasive disease-free survival (iDFS)

Overall response rate (ORR)

CTCAE scale (V4.0)

Eligibility Criteria

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-

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

Request coverage →

Source

Open on ClinicalTrials.gov