Breast NeoplasmPhase 2FASCINATE-NNCT05582499
Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
A Phase 2 study testing Dalpiciclib, Pyrotinib and SHR-A1811 in people with Breast Neoplasm and Breast Cancer, run by Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasm, Breast Cancer, Breast Tumors
- What is being tested?
- Dalpiciclib, Pyrotinib and SHR-A1811
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 716 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to Sep 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center Shanghai, China, 200032
Shanghai, Shanghai Municipality, 200032
Zhimin Shao, M.D., +86-021-64175590 ext. 88807, zhimingshao@yahoo.com
Min He, M.D, +86-021-64175590 ext. 88603, minsmiler@126.com
About this study
Official title: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)
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.
Read the 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.
- Conditions
- Breast Neoplasm, Breast Cancer, Breast Tumors, Triple-Negative Breast Cancer (TNBC), HER2-positive Breast Cancer, HER2-negative Breast Cancer
- Being tested
- Dalpiciclib, Pyrotinib, SHR-A1811, SHR-1316, Camrelizumab
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalpiciclibDrug
Also called SHR-6390
an oral cyclin-dependent kinases (CDK) 4/6 inhibitor
PyrotinibDrug
an irreversible dual pan-erbb receptor tyrosine kinase receptor tyrosine kinase (ERBB) inhibitor
SHR-A1811Drug
an anti-HER2 antibody-drug conjugate (ADC)
SHR-1316Drug
an anti-programmed death ligand 1 (PD-L1) antibody
CamrelizumabDrug
Also called SHR-1210
an anti-programmed death-1 (PD1) antibody
SHR-A1921Drug
Trophoblast cell-surface antigen 2 (TROP2) ADC
PertuzumabDrug
Pertuzumab
TrastuzumabDrug
Trastuzumab
GoserelinDrug
goserelin
LetrozoleDrug
letrozole
Nab paclitaxelDrug
Albumin paclitaxel
CarboplatinDrug
Carboplatin
EpirubicinDrug
Epirubicin
CyclophosphamideDrug
Cyclophosphamide
FluzoparibDrug
Also called SHR-3162
an original poly adenosine diphosphate-ribose polymerase (PARP) inhibitor
ApatinibDrug
tyrosine kinase inhibitors
FamitinibDrug
tyrosine kinase inhibitors
HB1801Drug
Albumin docetaxel
LEMDrug
liposome-entrapped mitoxantrone
TQB2102Drug
an anti-HER2 ADC
BenmelstobartDrug
an anti-PDL1 antibody
AnlotinibDrug
an tyrosine kinase inhibitor
TQB2868Drug
anti-PD-1/TGF-βRII
IvonescimabDrug
an anti-PD-1/VEGF bispecific antibody
JS207Drug
an anti-PD-1/VEGF bispecific antibody
JSKN003Drug
an anti-HER2 ADC
HRS-4508Drug
an HER2 inhibitor
SHR-4602Drug
an anti-HER2 ADC
paclitaxelDrug
paclitaxel
HRS-6209Drug
an oral cyclin-dependent kinases 4 (CDK4) inhibitor
9MW2821Drug
a Nectin-4 antibody-drug conjugate (ADC)
IBI354Drug
an anti-HER2 ADC
Stereotactic Body Radiation Therapy (SBRT)Radiation
Stereotactic Body Radiation Therapy (SBRT) is performed within 5 calendar days prior to the initiation of drug therapy. SBRT is delivered to the primary tumor in 3 fractions of 8 Gy each (total 24 Gy) over 3-5 days.
| Study group | Role | What they receive |
|---|---|---|
| L1-1 | Experimental | If patients were hormone receptor-positive (HR+) and HER2-negative (HER2-) defined as similarity network fusion 1(SNF1) subtype Receives: Drug: Dalpiciclib; Drug: Goserelin; Drug: Letrozole |
| L1-2 | Active comparator | If patients were HR+HER2- with SNF1 subtype Receives: Drug: Nab paclitaxel; Drug: Carboplatin |
| L2-2 | Active comparator | If patients were HR+HER2- with SNF2 subtype Receives: Drug: Nab paclitaxel; Drug: Carboplatin |
| L3-2 | Active comparator | If patients were HR+HER2- with SNF3 subtype Receives: Drug: Nab paclitaxel; Drug: Carboplatin |
| L4-2 | Active comparator | If patients were HR+HER2- with SNF4 subtype Receives: Drug: Nab paclitaxel; Drug: Carboplatin |
| L4-low-1 | Experimental | If patients were HR+HER2-low with SNF4 subtype Receives: Drug: SHR-A1811 |
| L4-low-2 | Active comparator | If patients were HR+HER2-low with SNF4 subtype Receives: Drug: Nab paclitaxel; Drug: Carboplatin |
| TN1-1 | Experimental | If patients were triple-negative breast cancer with immunomodulatory (IM) subtype Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Nab paclitaxel; Drug: Carboplatin; Drug: Epirubicin; Drug: Cyclophosphamide |
| TN4-1.1 | Experimental | If patients were HR-HER2-low Receives: Drug: SHR-A1811 |
| TN4-2 | Active comparator | If patients were HR-HER2-low Receives: Drug: Nab paclitaxel; Drug: Carboplatin; Drug: Epirubicin; Drug: Cyclophosphamide |
| TN5-1.1 | Experimental | If patients were triple-negative breast cancer with other subtypes Receives: Drug: SHR-A1921 |
| TN5-2 | Active comparator | If patients were triple-negative breast cancer with other subtypes Receives: Drug: Nab paclitaxel; Drug: Carboplatin; Drug: Epirubicin; Drug: Cyclophosphamide |
| H1-1.1 | Experimental | If patients were HR+HER2+ Receives: Drug: Pyrotinib; Drug: SHR-A1811 |
| H1-2 | Active comparator | If patients were HR+HER2+ Receives: Drug: Pertuzumab; Drug: Trastuzumab; Drug: Nab paclitaxel; Drug: Carboplatin |
| H2-1.1 | Experimental | If patients were HR-HER2+ Receives: Drug: Pyrotinib |
| H2-2 | Active comparator | If patients were HR-HER2+ Receives: 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 Receives: Drug: SHR-1316; Drug: Nab paclitaxel; Drug: Carboplatin |
| L3-1.2 | Experimental | If patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype Receives: Drug: Nab paclitaxel; Drug: Carboplatin; Drug: Fluzoparib |
| L4-1.2 | Experimental | If patients were HR+HER2- with similarity network fusion 4 (SNF4) subtype Receives: Drug: Nab paclitaxel; Drug: Carboplatin; Drug: Apatinib |
| TN5-1.2 | Experimental | If patients were triple-negative breast cancer with other subtypes Receives: Drug: SHR-1316; Drug: SHR-A1921 |
| H1-1.2 | Experimental | If patients were HR+HER2+ Receives: Drug: SHR-A1811 |
| H2-1.2 | Experimental | If patients were HR-HER2+ Receives: Drug: Pyrotinib; Drug: SHR-A1811 |
| TN4-1.2 | Experimental | If patients were HR-HER2-low Receives: Drug: SHR-A1811; Drug: Camrelizumab; Drug: Famitinib |
| L2-1.1 | Experimental | If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype Receives: Drug: Dalpiciclib; Drug: Goserelin; Drug: Letrozole |
| L2-1.3 | Experimental | If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype Receives: 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 Receives: Drug: Dalpiciclib; Drug: Goserelin; Drug: Letrozole |
| L4-1.1 | Experimental | If patients were HR+HER2- with similarity network fusion 4 (SNF4) subtype Receives: Drug: SHR-A1921 |
| L5-1 | Experimental | If patients were HR+HER2- Receives: Drug: Cyclophosphamide; Drug: HB1801; Drug: LEM |
| L5-2 | Experimental | If patients were HR+HER2- Receives: Drug: Cyclophosphamide; Drug: HB1801; Drug: LEM |
| L6 | Experimental | If patients were HR+HER2-low Receives: Drug: SHR-A1811; Drug: SHR-1316; Drug: Famitinib |
| L7 | Experimental | If patients were HR+HER2-low Receives: Drug: Famitinib; Drug: TQB2102; Drug: Benmelstobart |
| L8 | Experimental | If patients were HR+HER2- Receives: Drug: TQB2102; Drug: Anlotinib; Drug: TQB2868 |
| L9 | Experimental | If patients were HR+HER2-low Receives: Drug: Nab paclitaxel; Drug: Carboplatin; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Ivonescimab |
| TN6-1 | Experimental | TNBC Receives: Drug: SHR-A1811; Drug: SHR-1316; Drug: Famitinib |
| TN6-2 | Experimental | TNBC Receives: Drug: SHR-A1811; Drug: SHR-1316 |
| TN7-1 | Experimental | If patients were HR-HER2-low Receives: Drug: TQB2102; Drug: Benmelstobart |
| TN7-2 | Experimental | If patients were HR-HER2-low Receives: Drug: TQB2102; Drug: Benmelstobart; Drug: Anlotinib |
| TN8 | Experimental | TNBC Receives: Drug: TQB2102; Drug: TQB2868 |
| TN9 | Experimental | TNBC Receives: Drug: Carboplatin; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: paclitaxel |
| H3 | Experimental | If patients were HER2+ Receives: Drug: JSKN003 |
| H4-1 | Experimental | If patients were HER2+ Receives: Drug: SHR-A1811; Drug: Pertuzumab; Drug: Trastuzumab; Drug: Nab paclitaxel; Drug: Carboplatin |
| H4-2 | Experimental | If patients were HER2+ Receives: Drug: SHR-A1811 |
| H4-3 | Experimental | If patients were HER2+ Receives: Drug: Pertuzumab; Drug: Trastuzumab; Drug: Nab paclitaxel; Drug: Carboplatin |
| H4-4 | Experimental | If patients were HER2+ Receives: Drug: Pyrotinib; Drug: SHR-A1811 |
| H5 | Experimental | If patients were HER2+ Receives: Drug: SHR-A1811; Drug: SHR-4602 |
| H6-1 | Experimental | If patients were HER2+ Receives: Drug: SHR-A1811; Drug: HRS-4508 |
| H6-2 | Experimental | If patients were HER2+ Receives: Drug: SHR-A1811; Drug: Pertuzumab; Drug: HRS-4508 |
| L10 | Experimental | If patients were HR+HER2- Receives: Drug: Nab paclitaxel; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: JS207 |
| H8-1 | Experimental | If patients were HR+HER2+ Receives: Drug: SHR-A1811; Drug: Goserelin; Drug: Letrozole; Drug: HRS-6209 |
| H8-2 | Experimental | If patients were HR+HER2+ Receives: Drug: SHR-A1811; Drug: Goserelin; Drug: Letrozole |
| TN10 | Experimental | If patients were TNBC Receives: Drug: JS207; Drug: 9MW2821 |
| L11 | Experimental | If patients were HR+HER2- Receives: Drug: JS207; Drug: 9MW2821 |
| H9 | Experimental | If patients were HER2+ Receives: Drug: SHR-A1811; Drug: Pertuzumab; Drug: Trastuzumab; Drug: paclitaxel |
| H10 | Experimental | If patients were HER2+ Receives: Drug: Pertuzumab; Drug: IBI354 |
| TN6-3 | Experimental | TNBC Receives: Drug: SHR-A1811; Drug: SHR-1316; Drug: Nab paclitaxel; Drug: Carboplatin |
| TN11-1: TNBC patients predicted sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AI | Experimental | The TN11 arm explores AI-guided multidisciplinary precision therapy in TNBC. Patients are stratified using an established digital pathology-based AI model that predicts sensitivity to the combination therapy of Paclitaxel, Carboplatin, Camrelizumab and Famitinib. Patients predicted to be sensitive (TN11-1) receive this combination therapy directly. Receives: Drug: Camrelizumab; Drug: Carboplatin; Drug: Famitinib; Drug: paclitaxel |
| TN11-2: TNBC patients predicted non-sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AI | Experimental | TNBC patients predicted to be non-sensitive (TN11-2) to the combination therapy of Paclitaxel, Carboplatin, Camrelizumab and Famitinib first undergo stereotactic body radiation therapy (SBRT). SBRT is delivered to the primary tumor in 3 fractions of 8 Gy (total 24 Gy) over 3-5 days. Following SBRT, patients receive the combination therapy of Paclitaxel, Carboplatin, Camrelizumab and Famitinib. Receives: Drug: Camrelizumab; Drug: Carboplatin; Drug: Famitinib; Drug: paclitaxel; Radiation: Stereotactic Body Radiation Therapy (SBRT) |
| L12 | Experimental | Patients with HR+HER2- breast cancer, clinical stage cT1c-4, cN0-3, M0, with either tumor grade ≥2 or Ki-67 ≥20%. Patients first undergo stereotactic body radiotherapy (SBRT) to the primary tumor, followed by combination therapy of Paclitaxel + Epirubicin + Cyclophosphamide + Camrelizumab + Famitinib. Receives: Drug: Camrelizumab; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Famitinib; Drug: paclitaxel; Radiation: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate (pCR)
Pathological complete response rate
Measured: through study completion, up to 24 weeks
Secondary outcomes (5)
invasive disease-free survival (iDFS)
To determine three-year invasive disease-free survival (iDFS) among the treatment arms
Measured: Three-year Post-surgery Follow-up
Overall response rate (ORR)
Complete response (CR) + partial response (PR)
Measured: up to 24 weeks
CTCAE scale (V4.0)
- To evaluate the rate of adverse effects of patient by the standard CTCAE scale (V4.0)
Measured: through study completion, an average of 1 year
Evaluate gene expression profile during treatment
To measure gene expression profile of baseline and sequential tumor samples during treatment, through RNA-seq platform
Measured: through study completion, up to 24 weeks
Number of peripheral blood mononuclear cells (PBMC) count during treatment
To measure number of peripheral blood mononuclear cells (PBMC) count from baseline and sequential blood samples during treatment, through Flow CytoMetry platform
Measured: through study completion, up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Nov 2022
- Primary completion31 Dec 2027 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 716 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- Zhimin Shao, Professor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582499
- Sponsor's protocol ID
- FASCINATE-N
- Acronym
- FASCINATE-N
- Status last verified
- May 2026
- First submitted
- 25 Sep 2022
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xiao Y, Yang F, Qi YJ, Chen L, Zhang H, Zhang SW, Shan R, Huang L, Li JJ, Jiang YZ, Shao ZM. Multimodal assessment of exceptional responders refines subtyping-directed precision treatment in HR+/HER2- breast cancer. J Clin Invest. 2026 Oct 15;136(20):e202305. doi: 10.1172/JCI202305. eCollection 2026 Oct 15.
PubMed 42878074Zuo 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.
PubMed 38362377