Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)
Status and phase
Enrolling
Phase 2
Conditions
Breast Tumors
Breast Cancer
Breast Neoplasm
Locally Advanced Breast Cancer
Hormone Receptor Negative Tumor
Early-stage Breast Cancer
Hormone Receptor Positive Tumor
HER2-positive Breast Cancer
HER2-negative Breast Cancer
Triple-Negative Breast Cancer (TNBC)
Treatments
Drug: SHR-1316
Drug: TQB2868
Drug: Fluzoparib
Drug: Camrelizumab
Drug: HRS-4508
Drug: Ivonescimab
Drug: Epirubicin
Drug: Cyclophosphamide
Drug: JS207
Drug: JSKN003
Drug: HB1801
Drug: SHR-A1811
Drug: SHR-A1921
Drug: Apatinib
Drug: Benmelstobart
Drug: Famitinib
Drug: Dalpiciclib
Drug: SHR-4602
Drug: LEM
Drug: Letrozole
Drug: Anlotinib
Drug: Goserelin
Drug: Pertuzumab
Drug: paclitaxel
Drug: Nab paclitaxel
Drug: Pyrotinib
Drug: Trastuzumab
Drug: Carboplatin
Drug: TQB2102
Details and patient eligibility
About
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.
Full 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.
Enrollment
716 estimated patients
Sex
Female
Ages
18 to 70 years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
716 participants in 53 patient groups
L1-1
Experimental group
Description:
If patients were hormone receptor-positive (HR+) and HER2-negative (HER2-) defined as similarity network fusion 1(SNF1) subtype
Treatment:
Drug: Goserelin
Drug: Letrozole
Drug: Dalpiciclib
L1-2
Active Comparator group
Description:
If patients were HR+HER2- with SNF1 subtype
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
L2-2
Active Comparator group
Description:
If patients were HR+HER2- with SNF2 subtype
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
L3-2
Active Comparator group
Description:
If patients were HR+HER2- with SNF3 subtype
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
L4-2
Active Comparator group
Description:
If patients were HR+HER2- with SNF4 subtype
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
L4-low-1
Experimental group
Description:
If patients were HR+HER2-low with SNF4 subtype
Treatment:
Drug: SHR-A1811
L4-low-2
Active Comparator group
Description:
If patients were HR+HER2-low with SNF4 subtype
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
TN1-1
Experimental group
Description:
If patients were triple-negative breast cancer with immunomodulatory (IM) subtype
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
Drug: Cyclophosphamide
Drug: Epirubicin
Drug: Camrelizumab
TN1-2
Active Comparator group
Description:
If patients were triple-negative breast cancer with IM subtype
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
Drug: Cyclophosphamide
Drug: Epirubicin
TN2-1
Experimental group
Description:
If patients were triple-negative breast cancer with basal-like immune suppressed (BLIS) subtype
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
Drug: Cyclophosphamide
Drug: Epirubicin
Drug: Fluzoparib
TN2-2
Active Comparator group
Description:
If patients were triple-negative breast cancer with BLIS subtype
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
Drug: Cyclophosphamide
Drug: Epirubicin
TN3-1
Experimental group
Description:
If patients were triple-negative breast cancer with androgen receptor positive HER2 activated (AR HER2) subtype
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
Drug: Pyrotinib
Drug: Cyclophosphamide
Drug: Epirubicin
TN3-2
Active Comparator group
Description:
If patients were triple-negative breast cancer with AR HER2 subtype
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
Drug: Cyclophosphamide
Drug: Epirubicin
TN4-1.1
Experimental group
Description:
If patients were HR-HER2-low
Treatment:
Drug: SHR-A1811
TN4-2
Active Comparator group
Description:
If patients were HR-HER2-low
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
Drug: Cyclophosphamide
Drug: Epirubicin
TN5-1.1
Experimental group
Description:
If patients were triple-negative breast cancer with other subtypes
Treatment:
Drug: SHR-A1921
TN5-2
Active Comparator group
Description:
If patients were triple-negative breast cancer with other subtypes
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
Drug: Cyclophosphamide
Drug: Epirubicin
H1-1.1
Experimental group
Description:
If patients were HR+HER2+
Treatment:
Drug: Pyrotinib
Drug: SHR-A1811
H1-2
Active Comparator group
Description:
If patients were HR+HER2+
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
Drug: Trastuzumab
Drug: Pertuzumab
H2-1.1
Experimental group
Description:
If patients were HR-HER2+
Treatment:
Drug: Pyrotinib
H2-2
Active Comparator group
Description:
If patients were HR-HER2+
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
Drug: Trastuzumab
Drug: Pertuzumab
L2-1.2
Experimental group
Description:
If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
Drug: SHR-1316
L3-1.2
Experimental group
Description:
If patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
Drug: Fluzoparib
L4-1.2
Experimental group
Description:
If patients were HR+HER2- with similarity network fusion 4 (SNF4) subtype
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
Drug: Apatinib
TN5-1.2
Experimental group
Description:
If patients were triple-negative breast cancer with other subtypes
Treatment:
Drug: SHR-A1921
Drug: SHR-1316
H1-1.2
Experimental group
Description:
If patients were HR+HER2+
Treatment:
Drug: SHR-A1811
H2-1.2
Experimental group
Description:
If patients were HR-HER2+
Treatment:
Drug: Pyrotinib
Drug: SHR-A1811
TN4-1.2
Experimental group
Description:
If patients were HR-HER2-low
Treatment:
Drug: Famitinib
Drug: SHR-A1811
Drug: Camrelizumab
L2-1.1
Experimental group
Description:
If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype
Treatment:
Drug: Goserelin
Drug: Letrozole
Drug: Dalpiciclib
L2-1.3
Experimental group
Description:
If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
Drug: Famitinib
Drug: SHR-1316
L3-1.1
Experimental group
Description:
If patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype
Treatment:
Drug: Goserelin
Drug: Letrozole
Drug: Dalpiciclib
L4-1.1
Experimental group
Description:
If patients were HR+HER2- with similarity network fusion 4 (SNF4) subtype
Treatment:
Drug: SHR-A1921
L5-1
Experimental group
Description:
If patients were HR+HER2-
Treatment:
Drug: LEM
Drug: HB1801
Drug: Cyclophosphamide
L5-2
Experimental group
Description:
If patients were HR+HER2-
Treatment:
Drug: LEM
Drug: HB1801
Drug: Cyclophosphamide
L6
Experimental group
Description:
If patients were HR+HER2-low
Treatment:
Drug: Famitinib
Drug: SHR-A1811
Drug: SHR-1316
L7
Experimental group
Description:
If patients were HR+HER2-low
Treatment:
Drug: TQB2102
Drug: Famitinib
Drug: Benmelstobart
L8
Experimental group
Description:
If patients were HR+HER2-
Treatment:
Drug: TQB2102
Drug: Anlotinib
Drug: TQB2868
L9
Experimental group
Description:
If patients were HR+HER2-low
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
Drug: Cyclophosphamide
Drug: Epirubicin
Drug: Ivonescimab
TN6-1
Experimental group
Description:
TNBC
Treatment:
Drug: Famitinib
Drug: SHR-A1811
Drug: SHR-1316
TN6-2
Experimental group
Description:
TNBC
Treatment:
Drug: SHR-A1811
Drug: SHR-1316
TN7-1
Experimental group
Description:
If patients were HR-HER2-low
Treatment:
Drug: TQB2102
Drug: Benmelstobart
TN7-2
Experimental group
Description:
If patients were HR-HER2-low
Treatment:
Drug: TQB2102
Drug: Anlotinib
Drug: Benmelstobart
TN8
Experimental group
Description:
TNBC
Treatment:
Drug: TQB2102
Drug: TQB2868
TN9
Experimental group
Description:
TNBC
Treatment:
Drug: Carboplatin
Drug: paclitaxel
Drug: Cyclophosphamide
Drug: Epirubicin
H3
Experimental group
Description:
If patients were HER2+
Treatment:
Drug: JSKN003
H4-1
Experimental group
Description:
If patients were HER2+
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
Drug: Trastuzumab
Drug: Pertuzumab
Drug: SHR-A1811
H4-2
Experimental group
Description:
If patients were HER2+
Treatment:
Drug: SHR-A1811
H4-3
Experimental group
Description:
If patients were HER2+
Treatment:
Drug: Carboplatin
Drug: Nab paclitaxel
Drug: Trastuzumab
Drug: Pertuzumab
H4-4
Experimental group
Description:
If patients were HER2+
Treatment:
Drug: Pyrotinib
Drug: SHR-A1811
H5
Experimental group
Description:
If patients were HER2+
Treatment:
Drug: SHR-4602
Drug: SHR-A1811
H6-1
Experimental group
Description:
If patients were HER2+
Treatment:
Drug: SHR-A1811
Drug: HRS-4508
H6-2
Experimental group
Description:
If patients were HER2+
Treatment:
Drug: Pertuzumab
Drug: SHR-A1811
Drug: HRS-4508
L10
Experimental group
Description:
If patients were HR+HER2-
Treatment:
Drug: Nab paclitaxel
Drug: JS207
Drug: Cyclophosphamide
Drug: Epirubicin
Trial contacts and locations
1
Loading...
Central trial contact
Zhimin Shao, Professor
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2025 Veeva Systems