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
- Are there results?
- Not yet: the study is under way
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;
Show all 11Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)
- ClinicalTrials.gov ID
- NCT05582499
- Acronym / sponsor ID
- FASCINATE-N / FASCINATE-N
- Conditions
- Breast Neoplasm, Breast Cancer, Breast Tumors, Triple-Negative Breast Cancer (TNBC), HER2-positive Breast Cancer, HER2-negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 716 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 63
| Arm | Type | Receives |
|---|---|---|
| L1-1 | Experimental | Drug: Dalpiciclib, Drug: Goserelin, Drug: LetrozoleIf patients were hormone receptor-positive (HR+) and HER2-negative (HER2-) defined as similarity network fusion 1(SNF1) subtype |
| L1-2 | Active comparator | Drug: Nab paclitaxel, Drug: CarboplatinIf patients were HR+HER2- with SNF1 subtype |
| L2-2 | Active comparator | Drug: Nab paclitaxel, Drug: CarboplatinIf patients were HR+HER2- with SNF2 subtype |
| L3-2 | Active comparator | Drug: Nab paclitaxel, Drug: CarboplatinIf patients were HR+HER2- with SNF3 subtype |
| L4-2 | Active comparator | Drug: Nab paclitaxel, Drug: CarboplatinIf patients were HR+HER2- with SNF4 subtype |
| L4-low-1 | Experimental | Drug: SHR-A1811If patients were HR+HER2-low with SNF4 subtype |
| L4-low-2 | Active comparator | Drug: Nab paclitaxel, Drug: CarboplatinIf patients were HR+HER2-low with SNF4 subtype |
| TN1-1 | Experimental | Drug: Camrelizumab, Drug: Nab paclitaxel, Drug: Carboplatin, Drug: Epirubicin, Drug: CyclophosphamideIf patients were triple-negative breast cancer with immunomodulatory (IM) subtype |
| TN1-2 | Active comparator | Drug: Nab paclitaxel, Drug: Carboplatin, Drug: Epirubicin, Drug: CyclophosphamideIf patients were triple-negative breast cancer with IM subtype |
| TN2-1 | Experimental | Drug: Nab paclitaxel, Drug: Carboplatin, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: FluzoparibIf patients were triple-negative breast cancer with basal-like immune suppressed (BLIS) subtype |
| TN2-2 | Active comparator | Drug: Nab paclitaxel, Drug: Carboplatin, Drug: Epirubicin, Drug: CyclophosphamideIf patients were triple-negative breast cancer with BLIS subtype |
| TN3-1 | Experimental | Drug: Pyrotinib, Drug: Nab paclitaxel, Drug: Carboplatin, Drug: Epirubicin, Drug: CyclophosphamideIf patients were triple-negative breast cancer with androgen receptor positive HER2 activated (AR HER2) subtype |
| TN3-2 | Active comparator | Drug: Nab paclitaxel, Drug: Carboplatin, Drug: Epirubicin, Drug: CyclophosphamideIf patients were triple-negative breast cancer with AR HER2 subtype |
| TN4-1.1 | Experimental | Drug: SHR-A1811If patients were HR-HER2-low |
| TN4-2 | Active comparator | Drug: Nab paclitaxel, Drug: Carboplatin, Drug: Epirubicin, Drug: CyclophosphamideIf patients were HR-HER2-low |
| TN5-1.1 | Experimental | Drug: SHR-A1921If patients were triple-negative breast cancer with other subtypes |
| TN5-2 | Active comparator | Drug: Nab paclitaxel, Drug: Carboplatin, Drug: Epirubicin, Drug: CyclophosphamideIf patients were triple-negative breast cancer with other subtypes |
| H1-1.1 | Experimental | Drug: Pyrotinib, Drug: SHR-A1811If patients were HR+HER2+ |
| H1-2 | Active comparator | Drug: Pertuzumab, Drug: Trastuzumab, Drug: Nab paclitaxel, Drug: CarboplatinIf patients were HR+HER2+ |
| H2-1.1 | Experimental | Drug: PyrotinibIf patients were HR-HER2+ |
| H2-2 | Active comparator | Drug: Pertuzumab, Drug: Trastuzumab, Drug: Nab paclitaxel, Drug: CarboplatinIf patients were HR-HER2+ |
| L2-1.2 | Experimental | Drug: SHR-1316, Drug: Nab paclitaxel, Drug: CarboplatinIf patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype |
| L3-1.2 | Experimental | Drug: Nab paclitaxel, Drug: Carboplatin, Drug: FluzoparibIf patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype |
| L4-1.2 | Experimental | Drug: Nab paclitaxel, Drug: Carboplatin, Drug: ApatinibIf patients were HR+HER2- with similarity network fusion 4 (SNF4) subtype |
| TN5-1.2 | Experimental | Drug: SHR-1316, Drug: SHR-A1921If patients were triple-negative breast cancer with other subtypes |
| H1-1.2 | Experimental | Drug: SHR-A1811If patients were HR+HER2+ |
| H2-1.2 | Experimental | Drug: Pyrotinib, Drug: SHR-A1811If patients were HR-HER2+ |
| TN4-1.2 | Experimental | Drug: SHR-A1811, Drug: Camrelizumab, Drug: FamitinibIf patients were HR-HER2-low |
| L2-1.1 | Experimental | Drug: Dalpiciclib, Drug: Goserelin, Drug: LetrozoleIf patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype |
| L2-1.3 | Experimental | Drug: SHR-1316, Drug: Nab paclitaxel, Drug: Carboplatin, Drug: FamitinibIf patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype |
| L3-1.1 | Experimental | Drug: Dalpiciclib, Drug: Goserelin, Drug: LetrozoleIf patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype |
| L4-1.1 | Experimental | Drug: SHR-A1921If patients were HR+HER2- with similarity network fusion 4 (SNF4) subtype |
| L5-1 | Experimental | Drug: Cyclophosphamide, Drug: HB1801, Drug: LEMIf patients were HR+HER2- |
| L5-2 | Experimental | Drug: Cyclophosphamide, Drug: HB1801, Drug: LEMIf patients were HR+HER2- |
| L6 | Experimental | Drug: SHR-A1811, Drug: SHR-1316, Drug: FamitinibIf patients were HR+HER2-low |
| L7 | Experimental | Drug: Famitinib, Drug: TQB2102, Drug: BenmelstobartIf patients were HR+HER2-low |
| L8 | Experimental | Drug: TQB2102, Drug: Anlotinib, Drug: TQB2868If patients were HR+HER2- |
| L9 | Experimental | Drug: Nab paclitaxel, Drug: Carboplatin, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: IvonescimabIf patients were HR+HER2-low |
| TN6-1 | Experimental | Drug: SHR-A1811, Drug: SHR-1316, Drug: FamitinibTNBC |
| TN6-2 | Experimental | Drug: SHR-A1811, Drug: SHR-1316TNBC |
| TN7-1 | Experimental | Drug: TQB2102, Drug: BenmelstobartIf patients were HR-HER2-low |
| TN7-2 | Experimental | Drug: TQB2102, Drug: Benmelstobart, Drug: AnlotinibIf patients were HR-HER2-low |
| TN8 | Experimental | Drug: TQB2102, Drug: TQB2868TNBC |
| TN9 | Experimental | Drug: Carboplatin, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: paclitaxelTNBC |
| H3 | Experimental | Drug: JSKN003If patients were HER2+ |
| H4-1 | Experimental | Drug: SHR-A1811, Drug: Pertuzumab, Drug: Trastuzumab, Drug: Nab paclitaxel, Drug: CarboplatinIf patients were HER2+ |
| H4-2 | Experimental | Drug: SHR-A1811If patients were HER2+ |
| H4-3 | Experimental | Drug: Pertuzumab, Drug: Trastuzumab, Drug: Nab paclitaxel, Drug: CarboplatinIf patients were HER2+ |
| H4-4 | Experimental | Drug: Pyrotinib, Drug: SHR-A1811If patients were HER2+ |
| H5 | Experimental | Drug: SHR-A1811, Drug: SHR-4602If patients were HER2+ |
| H6-1 | Experimental | Drug: SHR-A1811, Drug: HRS-4508If patients were HER2+ |
| H6-2 | Experimental | Drug: SHR-A1811, Drug: Pertuzumab, Drug: HRS-4508If patients were HER2+ |
| L10 | Experimental | Drug: Nab paclitaxel, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: JS207If patients were HR+HER2- |
| H8-1 | Experimental | Drug: SHR-A1811, Drug: Goserelin, Drug: Letrozole, Drug: HRS-6209If patients were HR+HER2+ |
| H8-2 | Experimental | Drug: SHR-A1811, Drug: Goserelin, Drug: LetrozoleIf patients were HR+HER2+ |
| TN10 | Experimental | Drug: JS207, Drug: 9MW2821If patients were TNBC |
| L11 | Experimental | Drug: JS207, Drug: 9MW2821If patients were HR+HER2- |
| H9 | Experimental | Drug: SHR-A1811, Drug: Pertuzumab, Drug: Trastuzumab, Drug: paclitaxelIf patients were HER2+ |
| H10 | Experimental | Drug: Pertuzumab, Drug: IBI354If patients were HER2+ |
| TN6-3 | Experimental | Drug: SHR-A1811, Drug: SHR-1316, Drug: Nab paclitaxel, Drug: CarboplatinTNBC |
| TN11-1: TNBC patients predicted sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AI | Experimental | Drug: Camrelizumab, Drug: Carboplatin, Drug: Famitinib, Drug: paclitaxelThe 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. |
| TN11-2: TNBC patients predicted non-sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AI | Experimental | Drug: Camrelizumab, Drug: Carboplatin, Drug: Famitinib, Drug: paclitaxel, Radiation: Stereotactic Body Radiation Therapy (SBRT)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. |
| L12 | Experimental | Drug: Camrelizumab, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Famitinib, Drug: paclitaxel, Radiation: Stereotactic Body Radiation Therapy (SBRT)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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%；
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DalpiciclibAlso: SHR-6390an oral cyclin-dependent kinases (CDK) 4/6 inhibitor | Drug | L1-1, L2-1.1, L3-1.1 |
| Pyrotiniban irreversible dual pan-erbb receptor tyrosine kinase receptor tyrosine kinase (ERBB) inhibitor | Drug | H1-1.1, H2-1.1, H2-1.2, H4-4, TN3-1 |
| SHR-A1811an anti-HER2 antibody-drug conjugate (ADC) | Drug | H1-1.1, H1-1.2, H2-1.2, H4-1, H4-2, H4-4, H5, H6-1, H6-2, H8-1, H8-2, H9, L4-low-1, L6, TN4-1.1, TN4-1.2, TN6-1, TN6-2, TN6-3 |
| SHR-1316an anti-programmed death ligand 1 (PD-L1) antibody | Drug | L2-1.2, L2-1.3, L6, TN5-1.2, TN6-1, TN6-2, TN6-3 |
| CamrelizumabAlso: SHR-1210an anti-programmed death-1 (PD1) antibody | Drug | L12, TN1-1, TN11-1: TNBC patients predicted sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AI, TN11-2: TNBC patients predicted non-sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AI, TN4-1.2 |
| SHR-A1921Trophoblast cell-surface antigen 2 (TROP2) ADC | Drug | L4-1.1, TN5-1.1, TN5-1.2 |
| PertuzumabPertuzumab | Drug | H1-2, H10, H2-2, H4-1, H4-3, H6-2, H9 |
| TrastuzumabTrastuzumab | Drug | H1-2, H2-2, H4-1, H4-3, H9 |
| Goserelingoserelin | Drug | H8-1, H8-2, L1-1, L2-1.1, L3-1.1 |
| Letrozoleletrozole | Drug | H8-1, H8-2, L1-1, L2-1.1, L3-1.1 |
| Nab paclitaxelAlbumin paclitaxel | Drug | 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, TN6-3 |
| CarboplatinCarboplatin | Drug | 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, TN11-1: TNBC patients predicted sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AI, TN11-2: TNBC patients predicted non-sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AI, TN2-1, TN2-2, TN3-1, TN3-2, TN4-2, TN5-2, TN6-3, TN9 |
| EpirubicinEpirubicin | Drug | L10, L12, L9, TN1-1, TN1-2, TN2-1, TN2-2, TN3-1, TN3-2, TN4-2, TN5-2, TN9 |
| CyclophosphamideCyclophosphamide | Drug | L10, L12, L5-1, L5-2, L9, TN1-1, TN1-2, TN2-1, TN2-2, TN3-1, TN3-2, TN4-2, TN5-2, TN9 |
| FluzoparibAlso: SHR-3162an original poly adenosine diphosphate-ribose polymerase (PARP) inhibitor | Drug | L3-1.2, TN2-1 |
| Apatinibtyrosine kinase inhibitors | Drug | L4-1.2 |
| Famitinibtyrosine kinase inhibitors | Drug | L12, L2-1.3, L6, L7, TN11-1: TNBC patients predicted sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AI, TN11-2: TNBC patients predicted non-sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AI, TN4-1.2, TN6-1 |
| HB1801Albumin docetaxel | Drug | L5-1, L5-2 |
| LEMliposome-entrapped mitoxantrone | Drug | L5-1, L5-2 |
| TQB2102an anti-HER2 ADC | Drug | L7, L8, TN7-1, TN7-2, TN8 |
| Benmelstobartan anti-PDL1 antibody | Drug | L7, TN7-1, TN7-2 |
| Anlotiniban tyrosine kinase inhibitor | Drug | L8, TN7-2 |
| TQB2868anti-PD-1/TGF-βRII | Drug | L8, TN8 |
| Ivonescimaban anti-PD-1/VEGF bispecific antibody | Drug | L9 |
| JS207an anti-PD-1/VEGF bispecific antibody | Drug | L10, L11, TN10 |
| JSKN003an anti-HER2 ADC | Drug | H3 |
| HRS-4508an HER2 inhibitor | Drug | H6-1, H6-2 |
| SHR-4602an anti-HER2 ADC | Drug | H5 |
| paclitaxelpaclitaxel | Drug | H9, L12, TN11-1: TNBC patients predicted sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AI, TN11-2: TNBC patients predicted non-sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AI, TN9 |
| HRS-6209an oral cyclin-dependent kinases 4 (CDK4) inhibitor | Drug | H8-1 |
| 9MW2821a Nectin-4 antibody-drug conjugate (ADC) | Drug | L11, TN10 |
| IBI354an anti-HER2 ADC | Drug | H10 |
| Stereotactic Body Radiation Therapy (SBRT)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. | Radiation | L12, TN11-2: TNBC patients predicted non-sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AI |
Primary outcome
Pathological complete response rate (pCR)
Time frame: through study completion, up to 24 weeks
Pathological complete response rate
5 secondary outcomes
invasive disease-free survival (iDFS)
Time frame: Three-year Post-surgery Follow-up
Overall response rate (ORR)
Time frame: up to 24 weeks
CTCAE scale (V4.0)
Time frame: through study completion, an average of 1 year
Evaluate gene expression profile during treatment
Time frame: through study completion, up to 24 weeks
Number of peripheral blood mononuclear cells (PBMC) count during treatment
Time frame: through study completion, up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Derived from this study: PubMed 42878074Xiao 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.
- Derived from this study: PubMed 38362377Zuo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhimin Shao, Professor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhimin Shao, Professor (+86(021)64175590, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (pCR) (time frame: through study completion, up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05582499, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.