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

NCT05582499 | Recruiting Phase 2

• 1 other identifier: FASCINATE-N
• Study Type: interventional
• Target: 716
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm; Breast Cancer; Breast Tumors; Triple-Negative Breast Cancer (TNBC); HER2-positive Breast Cancer; HER2-negative Breast Cancer; Hormone Receptor Positive Tumor; Hormone Receptor Negative Tumor; Early-stage Breast Cancer; Locally Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate (pCR)

  Pathological complete response rate

  through study completion, up to 24 weeks

Secondary Outcomes (5)

• invasive disease-free survival (iDFS)

  Three-year Post-surgery Follow-up

• Overall response rate (ORR)

  up to 24 weeks

• CTCAE scale (V4.0)

  through study completion, an average of 1 year

• Evaluate gene expression profile during treatment

  through study completion, up to 24 weeks

• Number of peripheral blood mononuclear cells (PBMC) count during treatment

  through study completion, up to 24 weeks

Study Arms (53)

L1-1

EXPERIMENTAL

If patients were hormone receptor-positive (HR+) and HER2-negative (HER2-) defined as similarity network fusion 1(SNF1) subtype

Drug: Dalpiciclib; Drug: Goserelin; Drug: Letrozole

L1-2

ACTIVE COMPARATOR

If patients were HR+HER2- with SNF1 subtype

Drug: Nab paclitaxel; Drug: Carboplatin

L2-2

ACTIVE COMPARATOR

If patients were HR+HER2- with SNF2 subtype

Drug: Nab paclitaxel; Drug: Carboplatin

L3-2

ACTIVE COMPARATOR

If patients were HR+HER2- with SNF3 subtype

Drug: Nab paclitaxel; Drug: Carboplatin

L4-2

ACTIVE COMPARATOR

If patients were HR+HER2- with SNF4 subtype

Drug: Nab paclitaxel; Drug: Carboplatin

L4-low-1

EXPERIMENTAL

If patients were HR+HER2-low with SNF4 subtype

Drug: SHR-A1811

L4-low-2

ACTIVE COMPARATOR

If patients were HR+HER2-low with SNF4 subtype

Drug: Nab paclitaxel; Drug: Carboplatin

TN1-1

EXPERIMENTAL

If patients were triple-negative breast cancer with immunomodulatory (IM) subtype

Drug: Camrelizumab; Drug: Nab paclitaxel; Drug: Carboplatin; Drug: Epirubicin; Drug: Cyclophosphamide

TN1-2

ACTIVE COMPARATOR

If patients were triple-negative breast cancer with IM subtype

Drug: Nab paclitaxel; Drug: Carboplatin; Drug: Epirubicin; Drug: Cyclophosphamide

TN2-1

EXPERIMENTAL

If patients were triple-negative breast cancer with basal-like immune suppressed (BLIS) subtype

Drug: Nab paclitaxel; Drug: Carboplatin; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Fluzoparib

TN2-2

ACTIVE COMPARATOR

If patients were triple-negative breast cancer with BLIS subtype

Drug: Nab paclitaxel; Drug: Carboplatin; Drug: Epirubicin; Drug: Cyclophosphamide

TN3-1

EXPERIMENTAL

If patients were triple-negative breast cancer with androgen receptor positive HER2 activated (AR HER2) subtype

Drug: Pyrotinib; Drug: Nab paclitaxel; Drug: Carboplatin; Drug: Epirubicin; Drug: Cyclophosphamide

TN3-2

ACTIVE COMPARATOR

If patients were triple-negative breast cancer with AR HER2 subtype

Drug: Nab paclitaxel; Drug: Carboplatin; Drug: Epirubicin; Drug: Cyclophosphamide

TN4-1.1

EXPERIMENTAL

If patients were HR-HER2-low

Drug: SHR-A1811

TN4-2

ACTIVE COMPARATOR

If patients were HR-HER2-low

Drug: Nab paclitaxel; Drug: Carboplatin; Drug: Epirubicin; Drug: Cyclophosphamide

TN5-1.1

EXPERIMENTAL

If patients were triple-negative breast cancer with other subtypes

Drug: SHR-A1921

TN5-2

ACTIVE COMPARATOR

If patients were triple-negative breast cancer with other subtypes

Drug: Nab paclitaxel; Drug: Carboplatin; Drug: Epirubicin; Drug: Cyclophosphamide

H1-1.1

EXPERIMENTAL

If patients were HR+HER2+

Drug: Pyrotinib; Drug: SHR-A1811

H1-2

ACTIVE COMPARATOR

If patients were HR+HER2+

Drug: Pertuzumab; Drug: Trastuzumab; Drug: Nab paclitaxel; Drug: Carboplatin

H2-1.1

EXPERIMENTAL

If patients were HR-HER2+

Drug: Pyrotinib

H2-2

ACTIVE COMPARATOR

If patients were HR-HER2+

Drug: Pertuzumab; Drug: Trastuzumab; Drug: Nab paclitaxel; Drug: Carboplatin

L2-1.2

EXPERIMENTAL

If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype

Drug: SHR-1316; Drug: Nab paclitaxel; Drug: Carboplatin

L3-1.2

EXPERIMENTAL

If patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype

Drug: Nab paclitaxel; Drug: Carboplatin; Drug: Fluzoparib

L4-1.2

EXPERIMENTAL

If patients were HR+HER2- with similarity network fusion 4 (SNF4) subtype

Drug: Nab paclitaxel; Drug: Carboplatin; Drug: Apatinib

TN5-1.2

EXPERIMENTAL

If patients were triple-negative breast cancer with other subtypes

Drug: SHR-1316; Drug: SHR-A1921

H1-1.2

EXPERIMENTAL

If patients were HR+HER2+

Drug: SHR-A1811

H2-1.2

EXPERIMENTAL

If patients were HR-HER2+

Drug: Pyrotinib; Drug: SHR-A1811

TN4-1.2

EXPERIMENTAL

If patients were HR-HER2-low

Drug: SHR-A1811; Drug: Camrelizumab; Drug: Famitinib

L2-1.1

EXPERIMENTAL

If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype

Drug: Dalpiciclib; Drug: Goserelin; Drug: Letrozole

L2-1.3

EXPERIMENTAL

If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype

Drug: SHR-1316; Drug: Nab paclitaxel; Drug: Carboplatin; Drug: Famitinib

L3-1.1

EXPERIMENTAL

If patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype

Drug: Dalpiciclib; Drug: Goserelin; Drug: Letrozole

L4-1.1

EXPERIMENTAL

If patients were HR+HER2- with similarity network fusion 4 (SNF4) subtype

Drug: SHR-A1921

L5-1

EXPERIMENTAL

If patients were HR+HER2-

Drug: Cyclophosphamide; Drug: HB1801; Drug: LEM

L5-2

EXPERIMENTAL

If patients were HR+HER2-

Drug: Cyclophosphamide; Drug: HB1801; Drug: LEM

L6

EXPERIMENTAL

If patients were HR+HER2-low

Drug: SHR-A1811; Drug: SHR-1316; Drug: Famitinib

L7

EXPERIMENTAL

If patients were HR+HER2-low

Drug: Famitinib; Drug: TQB2102; Drug: Benmelstobart

L8

EXPERIMENTAL

If patients were HR+HER2-

Drug: TQB2102; Drug: Anlotinib; Drug: TQB2868

L9

EXPERIMENTAL

If patients were HR+HER2-low

Drug: Nab paclitaxel; Drug: Carboplatin; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Ivonescimab

TN6-1

EXPERIMENTAL

TNBC

Drug: SHR-A1811; Drug: SHR-1316; Drug: Famitinib

TN6-2

EXPERIMENTAL

TNBC

Drug: SHR-A1811; Drug: SHR-1316

TN7-1

EXPERIMENTAL

If patients were HR-HER2-low

Drug: TQB2102; Drug: Benmelstobart

TN7-2

EXPERIMENTAL

If patients were HR-HER2-low

Drug: TQB2102; Drug: Benmelstobart; Drug: Anlotinib

TN8

EXPERIMENTAL

TNBC

Drug: TQB2102; Drug: TQB2868

TN9

EXPERIMENTAL

TNBC

Drug: Carboplatin; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: paclitaxel

H3

EXPERIMENTAL

If patients were HER2+

Drug: JSKN003

H4-1

EXPERIMENTAL

If patients were HER2+

Drug: SHR-A1811; Drug: Pertuzumab; Drug: Trastuzumab; Drug: Nab paclitaxel; Drug: Carboplatin

H4-2

EXPERIMENTAL

If patients were HER2+

Drug: SHR-A1811

H4-3

EXPERIMENTAL

If patients were HER2+

Drug: Pertuzumab; Drug: Trastuzumab; Drug: Nab paclitaxel; Drug: Carboplatin

H4-4

EXPERIMENTAL

If patients were HER2+

Drug: Pyrotinib; Drug: SHR-A1811

H5

EXPERIMENTAL

If patients were HER2+

Drug: SHR-A1811; Drug: SHR-4602

H6-1

EXPERIMENTAL

If patients were HER2+

Drug: SHR-A1811; Drug: HRS-4508

H6-2

EXPERIMENTAL

If patients were HER2+

Drug: SHR-A1811; Drug: Pertuzumab; Drug: HRS-4508

L10

EXPERIMENTAL

If patients were HR+HER2-

Drug: Nab paclitaxel; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: JS207

Interventions

Dalpiciclib DRUG

an oral cyclin-dependent kinases (CDK) 4/6 inhibitor

Also known as: SHR-6390

L1-1; L2-1.1; L3-1.1

Pyrotinib DRUG

an irreversible dual pan-erbb receptor tyrosine kinase receptor tyrosine kinase (ERBB) inhibitor

H1-1.1; H2-1.1; H2-1.2; H4-4; TN3-1

SHR-A1811 DRUG

an anti-HER2 antibody-drug conjugate (ADC)

H1-1.1; H1-1.2; H2-1.2; H4-1; H4-2; H4-4; H5; H6-1; H6-2; L4-low-1; L6; TN4-1.1; TN4-1.2; TN6-1; TN6-2

SHR-1316 DRUG

an anti-programmed death ligand 1 (PD-L1) antibody

L2-1.2; L2-1.3; L6; TN5-1.2; TN6-1; TN6-2

Camrelizumab DRUG

an anti-programmed death-1 (PD1) antibody

Also known as: SHR-1210

TN1-1; TN4-1.2

SHR-A1921 DRUG

Trophoblast cell-surface antigen 2 (TROP2) ADC

L4-1.1; TN5-1.1; TN5-1.2

Pertuzumab DRUG

Pertuzumab

H1-2; H2-2; H4-1; H4-3; H6-2

Trastuzumab DRUG

Trastuzumab

H1-2; H2-2; H4-1; H4-3

Goserelin DRUG

goserelin

L1-1; L2-1.1; L3-1.1

Letrozole DRUG

letrozole

L1-1; L2-1.1; L3-1.1

Nab paclitaxel DRUG

Albumin paclitaxel

H1-2; H2-2; H4-1; H4-3; L1-2; L10; L2-1.2; L2-1.3; L2-2; L3-1.2; L3-2; L4-1.2; L4-2; L4-low-2; L9; TN1-1; TN1-2; TN2-1; TN2-2; TN3-1; TN3-2; TN4-2; TN5-2

Carboplatin DRUG

Carboplatin

H1-2; H2-2; H4-1; H4-3; L1-2; L2-1.2; L2-1.3; L2-2; L3-1.2; L3-2; L4-1.2; L4-2; L4-low-2; L9; TN1-1; TN1-2; TN2-1; TN2-2; TN3-1; TN3-2; TN4-2; TN5-2; TN9

Epirubicin DRUG

Epirubicin

L10; L9; TN1-1; TN1-2; TN2-1; TN2-2; TN3-1; TN3-2; TN4-2; TN5-2; TN9

Cyclophosphamide DRUG

Cyclophosphamide

L10; L5-1; L5-2; L9; TN1-1; TN1-2; TN2-1; TN2-2; TN3-1; TN3-2; TN4-2; TN5-2; TN9

Fluzoparib DRUG

an original poly adenosine diphosphate-ribose polymerase (PARP) inhibitor

Also known as: SHR-3162

L3-1.2; TN2-1

Apatinib DRUG

tyrosine kinase inhibitors

L4-1.2

Famitinib DRUG

tyrosine kinase inhibitors

L2-1.3; L6; L7; TN4-1.2; TN6-1

HB1801 DRUG

Albumin docetaxel

L5-1; L5-2

LEM DRUG

liposome-entrapped mitoxantrone

L5-1; L5-2

TQB2102 DRUG

an anti-HER2 ADC

L7; L8; TN7-1; TN7-2; TN8

Benmelstobart DRUG

an anti-PDL1 antibody

L7; TN7-1; TN7-2

Anlotinib DRUG

an tyrosine kinase inhibitor

L8; TN7-2

TQB2868 DRUG

anti-PD-1/TGF-βRII

L8; TN8

Ivonescimab DRUG

an anti-PD-1/VEGF bispecific antibody

L9

JS207 DRUG

an anti-PD-1/VEGF bispecific antibody

L10

JSKN003 DRUG

an anti-HER2 ADC

H3

HRS-4508 DRUG

an HER2 inhibitor

H6-1; H6-2

SHR-4602 DRUG

an anti-HER2 ADC

H5

paclitaxel DRUG

paclitaxel

TN9

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center Shanghai, China, 200032

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• Zuo WJ, Chen L, Shen Y, Wang ZH, Liu GY, Yu KD, Di GH, Wu J, Li JJ, Shao ZM. Rational and trial design of FASCINATE-N: a prospective, randomized, precision-based umbrella trial. Ther Adv Med Oncol. 2024 Feb 14;16:17588359231225032. doi: 10.1177/17588359231225032. eCollection 2024.

  PMID: 38362377 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

dalpiciclib; pyrotinib; camrelizumab; pertuzumab; Trastuzumab; Goserelin; Letrozole; Taxes; Carboplatin; Epirubicin; Cyclophosphamide; fluzoparib; apatinib; famitinib; anlotinib; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Oligopeptides; Nerve Tissue Proteins; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Economics; Health Care Economics and Organizations; Coordination Complexes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Zhimin Shao, Professor

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhimin Shao, Professor

CONTACT

+86(021)64175590; zhimingshao@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: October 17, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)