Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy

Phase 2

Recruiting

• Conditions: Breast Neoplasm; HER2-positive Breast Cancer; HER2-negative Breast Cancer; Hormone Receptor Positive Tumor; Breast Cancer; Breast Tumors; Hormone Receptor Negative Tumor; Triple-Negative Breast Cancer (TNBC); Locally Advanced Breast Cancer; Early-stage Breast Cancer
• Interventions: Drug: Dalpiciclib; Drug: Nab paclitaxel; Drug: SHR-A1811; Drug: Camrelizumab; Drug: Pyrotinib; Drug: SHR-A1921; Drug: Pertuzumab; Drug: SHR-1316; Drug: JSKN003; Drug: Goserelin; Drug: Carboplatin; Drug: Trastuzumab; Drug: HB1801; Drug: TQB2102; Drug: Anlotinib; Drug: SHR-4602; Drug: HRS-4508; Drug: Letrozole; Drug: Apatinib; Drug: Famitinib; Drug: LEM; Drug: Benmelstobart; Drug: TQB2868; Drug: Epirubicin; Drug: paclitaxel; Drug: JS207; Drug: Cyclophosphamide; Drug: Fluzoparib; Drug: Ivonescimab

• Registration Number: NCT05582499
• Lead Sponsor: Fudan University

Brief 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.

Detailed Description

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 Timeline

• Study First Submitted: 2022-09-25
• Study First Submitted QC: 2022-10-13
• Study First Posted: 2022-10-17
• Study Start: 2022-11-01
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-18
• Last Update Posted: 2025-08-22
• Primary Completion: 2026-12-31
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 716

Inclusion Criteria

• 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 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L1-1	Dalpiciclib	If patients were hormone receptor-positive (HR+) and HER2-negative (HER2-) defined as similarity network fusion 1(SNF1) subtype
L1-1	Goserelin	If patients were hormone receptor-positive (HR+) and HER2-negative (HER2-) defined as similarity network fusion 1(SNF1) subtype
L1-1	Letrozole	If patients were hormone receptor-positive (HR+) and HER2-negative (HER2-) defined as similarity network fusion 1(SNF1) subtype
L1-2	Nab paclitaxel	If patients were HR+HER2- with SNF1 subtype
L1-2	Carboplatin	If patients were HR+HER2- with SNF1 subtype
L2-2	Nab paclitaxel	If patients were HR+HER2- with SNF2 subtype
L2-2	Carboplatin	If patients were HR+HER2- with SNF2 subtype
L3-2	Nab paclitaxel	If patients were HR+HER2- with SNF3 subtype
L3-2	Carboplatin	If patients were HR+HER2- with SNF3 subtype
L4-2	Nab paclitaxel	If patients were HR+HER2- with SNF4 subtype
L4-2	Carboplatin	If patients were HR+HER2- with SNF4 subtype
L4-low-1	SHR-A1811	If patients were HR+HER2-low with SNF4 subtype
L4-low-2	Nab paclitaxel	If patients were HR+HER2-low with SNF4 subtype
L4-low-2	Carboplatin	If patients were HR+HER2-low with SNF4 subtype
TN1-1	Camrelizumab	If patients were triple-negative breast cancer with immunomodulatory (IM) subtype
TN1-1	Nab paclitaxel	If patients were triple-negative breast cancer with immunomodulatory (IM) subtype
TN1-1	Carboplatin	If patients were triple-negative breast cancer with immunomodulatory (IM) subtype
TN1-1	Epirubicin	If patients were triple-negative breast cancer with immunomodulatory (IM) subtype
TN1-1	Cyclophosphamide	If patients were triple-negative breast cancer with immunomodulatory (IM) subtype
TN1-2	Nab paclitaxel	If patients were triple-negative breast cancer with IM subtype
TN1-2	Carboplatin	If patients were triple-negative breast cancer with IM subtype
TN1-2	Epirubicin	If patients were triple-negative breast cancer with IM subtype
TN1-2	Cyclophosphamide	If patients were triple-negative breast cancer with IM subtype
TN2-1	Nab paclitaxel	If patients were triple-negative breast cancer with basal-like immune suppressed (BLIS) subtype
TN2-1	Carboplatin	If patients were triple-negative breast cancer with basal-like immune suppressed (BLIS) subtype
TN2-1	Epirubicin	If patients were triple-negative breast cancer with basal-like immune suppressed (BLIS) subtype
TN2-1	Cyclophosphamide	If patients were triple-negative breast cancer with basal-like immune suppressed (BLIS) subtype
TN2-1	Fluzoparib	If patients were triple-negative breast cancer with basal-like immune suppressed (BLIS) subtype
TN2-2	Nab paclitaxel	If patients were triple-negative breast cancer with BLIS subtype
TN2-2	Carboplatin	If patients were triple-negative breast cancer with BLIS subtype
TN2-2	Epirubicin	If patients were triple-negative breast cancer with BLIS subtype
TN2-2	Cyclophosphamide	If patients were triple-negative breast cancer with BLIS subtype
TN3-1	Pyrotinib	If patients were triple-negative breast cancer with androgen receptor positive HER2 activated (AR HER2) subtype
TN3-1	Nab paclitaxel	If patients were triple-negative breast cancer with androgen receptor positive HER2 activated (AR HER2) subtype
TN3-1	Carboplatin	If patients were triple-negative breast cancer with androgen receptor positive HER2 activated (AR HER2) subtype
TN3-1	Epirubicin	If patients were triple-negative breast cancer with androgen receptor positive HER2 activated (AR HER2) subtype
TN3-1	Cyclophosphamide	If patients were triple-negative breast cancer with androgen receptor positive HER2 activated (AR HER2) subtype
TN3-2	Nab paclitaxel	If patients were triple-negative breast cancer with AR HER2 subtype
TN3-2	Carboplatin	If patients were triple-negative breast cancer with AR HER2 subtype
TN3-2	Epirubicin	If patients were triple-negative breast cancer with AR HER2 subtype
TN3-2	Cyclophosphamide	If patients were triple-negative breast cancer with AR HER2 subtype
TN4-1.1	SHR-A1811	If patients were HR-HER2-low
TN4-2	Nab paclitaxel	If patients were HR-HER2-low
TN4-2	Carboplatin	If patients were HR-HER2-low
TN4-2	Epirubicin	If patients were HR-HER2-low
TN4-2	Cyclophosphamide	If patients were HR-HER2-low
TN5-1.1	SHR-A1921	If patients were triple-negative breast cancer with other subtypes
TN5-2	Nab paclitaxel	If patients were triple-negative breast cancer with other subtypes
TN5-2	Carboplatin	If patients were triple-negative breast cancer with other subtypes
TN5-2	Epirubicin	If patients were triple-negative breast cancer with other subtypes
TN5-2	Cyclophosphamide	If patients were triple-negative breast cancer with other subtypes
H1-1.1	Pyrotinib	If patients were HR+HER2+
H1-1.1	SHR-A1811	If patients were HR+HER2+
H1-2	Pertuzumab	If patients were HR+HER2+
H1-2	Trastuzumab	If patients were HR+HER2+
H1-2	Nab paclitaxel	If patients were HR+HER2+
H1-2	Carboplatin	If patients were HR+HER2+
H2-1.1	Pyrotinib	If patients were HR-HER2+
H2-2	Pertuzumab	If patients were HR-HER2+
H2-2	Trastuzumab	If patients were HR-HER2+
H2-2	Nab paclitaxel	If patients were HR-HER2+
H2-2	Carboplatin	If patients were HR-HER2+
L2-1.2	SHR-1316	If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype
L2-1.2	Nab paclitaxel	If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype
L2-1.2	Carboplatin	If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype
L3-1.2	Nab paclitaxel	If patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype
L3-1.2	Carboplatin	If patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype
L3-1.2	Fluzoparib	If patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype
L4-1.2	Nab paclitaxel	If patients were HR+HER2- with similarity network fusion 4 (SNF4) subtype
L4-1.2	Carboplatin	If patients were HR+HER2- with similarity network fusion 4 (SNF4) subtype
L4-1.2	Apatinib	If patients were HR+HER2- with similarity network fusion 4 (SNF4) subtype
TN5-1.2	SHR-1316	If patients were triple-negative breast cancer with other subtypes
TN5-1.2	SHR-A1921	If patients were triple-negative breast cancer with other subtypes
H1-1.2	SHR-A1811	If patients were HR+HER2+
H2-1.2	Pyrotinib	If patients were HR-HER2+
H2-1.2	SHR-A1811	If patients were HR-HER2+
TN4-1.2	SHR-A1811	If patients were HR-HER2-low
TN4-1.2	Camrelizumab	If patients were HR-HER2-low
TN4-1.2	Famitinib	If patients were HR-HER2-low
L2-1.1	Dalpiciclib	If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype
L2-1.1	Goserelin	If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype
L2-1.1	Letrozole	If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype
L2-1.3	SHR-1316	If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype
L2-1.3	Nab paclitaxel	If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype
L2-1.3	Carboplatin	If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype
L2-1.3	Famitinib	If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype
L3-1.1	Dalpiciclib	If patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype
L3-1.1	Goserelin	If patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype
L3-1.1	Letrozole	If patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype
L4-1.1	SHR-A1921	If patients were HR+HER2- with similarity network fusion 4 (SNF4) subtype
L5-1	Cyclophosphamide	If patients were HR+HER2-
L5-1	HB1801	If patients were HR+HER2-
L5-1	LEM	If patients were HR+HER2-
L5-2	Cyclophosphamide	If patients were HR+HER2-
L5-2	HB1801	If patients were HR+HER2-
L5-2	LEM	If patients were HR+HER2-
L6	SHR-A1811	If patients were HR+HER2-low
L6	SHR-1316	If patients were HR+HER2-low
L6	Famitinib	If patients were HR+HER2-low
L7	Famitinib	If patients were HR+HER2-low
L7	TQB2102	If patients were HR+HER2-low
L7	Benmelstobart	If patients were HR+HER2-low
L8	TQB2102	If patients were HR+HER2-
L8	Anlotinib	If patients were HR+HER2-
L8	TQB2868	If patients were HR+HER2-
L9	Nab paclitaxel	If patients were HR+HER2-low
L9	Carboplatin	If patients were HR+HER2-low
L9	Epirubicin	If patients were HR+HER2-low
L9	Cyclophosphamide	If patients were HR+HER2-low
L9	Ivonescimab	If patients were HR+HER2-low
TN6-1	SHR-A1811	TNBC
TN6-1	SHR-1316	TNBC
TN6-1	Famitinib	TNBC
TN6-2	SHR-A1811	TNBC
TN6-2	SHR-1316	TNBC
TN7-1	TQB2102	If patients were HR-HER2-low
TN7-1	Benmelstobart	If patients were HR-HER2-low
TN7-2	TQB2102	If patients were HR-HER2-low
TN7-2	Benmelstobart	If patients were HR-HER2-low
TN7-2	Anlotinib	If patients were HR-HER2-low
TN8	TQB2102	TNBC
TN8	TQB2868	TNBC
TN9	Carboplatin	TNBC
TN9	Epirubicin	TNBC
TN9	Cyclophosphamide	TNBC
TN9	paclitaxel	TNBC
H3	JSKN003	If patients were HER2+
H4-1	SHR-A1811	If patients were HER2+
H4-1	Pertuzumab	If patients were HER2+
H4-1	Trastuzumab	If patients were HER2+
H4-1	Nab paclitaxel	If patients were HER2+
H4-1	Carboplatin	If patients were HER2+
H4-2	SHR-A1811	If patients were HER2+
H4-3	Pertuzumab	If patients were HER2+
H4-3	Trastuzumab	If patients were HER2+
H4-3	Nab paclitaxel	If patients were HER2+
H4-3	Carboplatin	If patients were HER2+
H4-4	Pyrotinib	If patients were HER2+
H4-4	SHR-A1811	If patients were HER2+
H5	SHR-A1811	If patients were HER2+
H5	SHR-4602	If patients were HER2+
H6-1	SHR-A1811	If patients were HER2+
H6-1	HRS-4508	If patients were HER2+
H6-2	SHR-A1811	If patients were HER2+
H6-2	Pertuzumab	If patients were HER2+
H6-2	HRS-4508	If patients were HER2+
L10	Nab paclitaxel	If patients were HR+HER2-
L10	Epirubicin	If patients were HR+HER2-
L10	Cyclophosphamide	If patients were HR+HER2-
L10	JS207	If patients were HR+HER2-

Primary Outcome Measures

Name	Time	Method
Pathological complete response rate (pCR)	through study completion, up to 24 weeks	Pathological complete response rate

Secondary Outcome Measures

Name	Time	Method
invasive disease-free survival (iDFS)	Three-year Post-surgery Follow-up	To determine three-year invasive disease-free survival (iDFS) among the treatment arms
Overall response rate (ORR)	up to 24 weeks	Complete response (CR) + partial response (PR)
CTCAE scale (V4.0)	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	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	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

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center Shanghai, China, 200032; 🇨🇳 Shanghai, Shanghai, China