Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)

May 22, 2026 updated by: Zhimin Shao, Fudan University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

716

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Zhimin Shao, Professor
Phone Number: +86(021)64175590
Email: zhimingshao@yahoo.com

Study Locations

China
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200032
    - Recruiting
    - Fudan University Shanghai Cancer Center Shanghai, China, 200032
    - Contact:
      
      Zhimin Shao, M.D.
      
      Phone Number: 88807 +86-021-64175590
      
      Email: zhimingshao@yahoo.com
    - Contact:
      
      Min He, M.D
      
      Phone Number: 88603 +86-021-64175590
      
      Email: minsmiler@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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;
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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: L1-1 If patients were hormone receptor-positive (HR+) and HER2-negative (HER2-) defined as similarity network fusion 1(SNF1) subtype	Drug: Dalpiciclib an oral cyclin-dependent kinases (CDK) 4/6 inhibitor Other Names: SHR-6390 Drug: Goserelin goserelin Drug: Letrozole letrozole
Active Comparator: L1-2 If patients were HR+HER2- with SNF1 subtype	Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin
Active Comparator: L2-2 If patients were HR+HER2- with SNF2 subtype	Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin
Active Comparator: L3-2 If patients were HR+HER2- with SNF3 subtype	Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin
Active Comparator: L4-2 If patients were HR+HER2- with SNF4 subtype	Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin
Experimental: L4-low-1 If patients were HR+HER2-low with SNF4 subtype	Drug: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC)
Active Comparator: L4-low-2 If patients were HR+HER2-low with SNF4 subtype	Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin
Experimental: TN1-1 If patients were triple-negative breast cancer with immunomodulatory (IM) subtype	Drug: Cyclophosphamide Cyclophosphamide Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin Drug: Camrelizumab an anti-programmed death-1 (PD1) antibody Other Names: SHR-1210 Drug: Epirubicin Epirubicin
Active Comparator: TN1-2 If patients were triple-negative breast cancer with IM subtype	Drug: Cyclophosphamide Cyclophosphamide Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin Drug: Epirubicin Epirubicin
Experimental: TN2-1 If patients were triple-negative breast cancer with basal-like immune suppressed (BLIS) subtype	Drug: Cyclophosphamide Cyclophosphamide Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin Drug: Fluzoparib an original poly adenosine diphosphate-ribose polymerase (PARP) inhibitor Other Names: SHR-3162 Drug: Epirubicin Epirubicin
Active Comparator: TN2-2 If patients were triple-negative breast cancer with BLIS subtype	Drug: Cyclophosphamide Cyclophosphamide Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin Drug: Epirubicin Epirubicin
Experimental: TN3-1 If patients were triple-negative breast cancer with androgen receptor positive HER2 activated (AR HER2) subtype	Drug: Cyclophosphamide Cyclophosphamide Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin Drug: Epirubicin Epirubicin Drug: Pyrotinib an irreversible dual pan-erbb receptor tyrosine kinase receptor tyrosine kinase (ERBB) inhibitor
Active Comparator: TN3-2 If patients were triple-negative breast cancer with AR HER2 subtype	Drug: Cyclophosphamide Cyclophosphamide Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin Drug: Epirubicin Epirubicin
Active Comparator: TN4-2 If patients were HR-HER2-low	Drug: Cyclophosphamide Cyclophosphamide Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin Drug: Epirubicin Epirubicin
Active Comparator: TN5-2 If patients were triple-negative breast cancer with other subtypes	Drug: Cyclophosphamide Cyclophosphamide Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin Drug: Epirubicin Epirubicin
Active Comparator: H1-2 If patients were HR+HER2+	Drug: Trastuzumab Trastuzumab Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin Drug: Pertuzumab Pertuzumab
Active Comparator: H2-2 If patients were HR-HER2+	Drug: Trastuzumab Trastuzumab Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin Drug: Pertuzumab Pertuzumab
Experimental: L2-1.1 If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype	Drug: Dalpiciclib an oral cyclin-dependent kinases (CDK) 4/6 inhibitor Other Names: SHR-6390 Drug: Goserelin goserelin Drug: Letrozole letrozole
Experimental: L3-1.1 If patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype	Drug: Dalpiciclib an oral cyclin-dependent kinases (CDK) 4/6 inhibitor Other Names: SHR-6390 Drug: Goserelin goserelin Drug: Letrozole letrozole
Experimental: L4-1.1 If patients were HR+HER2- with similarity network fusion 4 (SNF4) subtype	Drug: SHR-A1921 Trophoblast cell-surface antigen 2 (TROP2) ADC
Experimental: TN4-1.1 If patients were HR-HER2-low	Drug: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC)
Experimental: TN5-1.1 If patients were triple-negative breast cancer with other subtypes	Drug: SHR-A1921 Trophoblast cell-surface antigen 2 (TROP2) ADC
Experimental: H1-1.1 If patients were HR+HER2+	Drug: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC) Drug: Pyrotinib an irreversible dual pan-erbb receptor tyrosine kinase receptor tyrosine kinase (ERBB) inhibitor
Experimental: H2-1.1 If patients were HR-HER2+	Drug: Pyrotinib an irreversible dual pan-erbb receptor tyrosine kinase receptor tyrosine kinase (ERBB) inhibitor
Experimental: L2-1.2 If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype	Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin Drug: SHR-1316 an anti-programmed death ligand 1 (PD-L1) antibody
Experimental: L3-1.2 If patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype	Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin Drug: Fluzoparib an original poly adenosine diphosphate-ribose polymerase (PARP) inhibitor Other Names: SHR-3162
Experimental: L4-1.2 If patients were HR+HER2- with similarity network fusion 4 (SNF4) subtype	Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin Drug: Apatinib tyrosine kinase inhibitors
Experimental: TN5-1.2 If patients were triple-negative breast cancer with other subtypes	Drug: SHR-1316 an anti-programmed death ligand 1 (PD-L1) antibody Drug: SHR-A1921 Trophoblast cell-surface antigen 2 (TROP2) ADC
Experimental: H1-1.2 If patients were HR+HER2+	Drug: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC)
Experimental: H2-1.2 If patients were HR-HER2+	Drug: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC) Drug: Pyrotinib an irreversible dual pan-erbb receptor tyrosine kinase receptor tyrosine kinase (ERBB) inhibitor
Experimental: TN4-1.2 If patients were HR-HER2-low	Drug: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC) Drug: Camrelizumab an anti-programmed death-1 (PD1) antibody Other Names: SHR-1210 Drug: Famitinib tyrosine kinase inhibitors
Experimental: L2-1.3 If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype	Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin Drug: SHR-1316 an anti-programmed death ligand 1 (PD-L1) antibody Drug: Famitinib tyrosine kinase inhibitors
Experimental: L5-1 If patients were HR+HER2-	Drug: Cyclophosphamide Cyclophosphamide Drug: HB1801 Albumin docetaxel Drug: LEM liposome-entrapped mitoxantrone
Experimental: L5-2 If patients were HR+HER2-	Drug: Cyclophosphamide Cyclophosphamide Drug: HB1801 Albumin docetaxel Drug: LEM liposome-entrapped mitoxantrone
Experimental: L6 If patients were HR+HER2-low	Drug: SHR-1316 an anti-programmed death ligand 1 (PD-L1) antibody Drug: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC) Drug: Famitinib tyrosine kinase inhibitors
Experimental: L7 If patients were HR+HER2-low	Drug: Famitinib tyrosine kinase inhibitors Drug: TQB2102 an anti-HER2 ADC Drug: Benmelstobart an anti-PDL1 antibody
Experimental: L8 If patients were HR+HER2-	Drug: TQB2102 an anti-HER2 ADC Drug: Anlotinib an tyrosine kinase inhibitor Drug: TQB2868 anti-PD-1/TGF-βRII
Experimental: L9 If patients were HR+HER2-low	Drug: Cyclophosphamide Cyclophosphamide Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin Drug: Epirubicin Epirubicin Drug: Ivonescimab an anti-PD-1/VEGF bispecific antibody
Experimental: TN6-1 TNBC	Drug: SHR-1316 an anti-programmed death ligand 1 (PD-L1) antibody Drug: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC) Drug: Famitinib tyrosine kinase inhibitors
Experimental: TN6-2 TNBC	Drug: SHR-1316 an anti-programmed death ligand 1 (PD-L1) antibody Drug: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC)
Experimental: TN7-1 If patients were HR-HER2-low	Drug: TQB2102 an anti-HER2 ADC Drug: Benmelstobart an anti-PDL1 antibody
Experimental: TN7-2 If patients were HR-HER2-low	Drug: TQB2102 an anti-HER2 ADC Drug: Benmelstobart an anti-PDL1 antibody Drug: Anlotinib an tyrosine kinase inhibitor
Experimental: TN8 TNBC	Drug: TQB2102 an anti-HER2 ADC Drug: TQB2868 anti-PD-1/TGF-βRII
Experimental: TN9 TNBC	Drug: Cyclophosphamide Cyclophosphamide Drug: paclitaxel paclitaxel Drug: Carboplatin Carboplatin Drug: Epirubicin Epirubicin
Experimental: H3 If patients were HER2+	Drug: JSKN003 an anti-HER2 ADC
Experimental: H4-1 If patients were HER2+	Drug: Trastuzumab Trastuzumab Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin Drug: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC) Drug: Pertuzumab Pertuzumab
Experimental: H4-2 If patients were HER2+	Drug: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC)
Experimental: H4-3 If patients were HER2+	Drug: Trastuzumab Trastuzumab Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin Drug: Pertuzumab Pertuzumab
Experimental: H4-4 If patients were HER2+	Drug: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC) Drug: Pyrotinib an irreversible dual pan-erbb receptor tyrosine kinase receptor tyrosine kinase (ERBB) inhibitor
Experimental: H5 If patients were HER2+	Drug: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC) Drug: SHR-4602 an anti-HER2 ADC
Experimental: H6-1 If patients were HER2+	Drug: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC) Drug: HRS-4508 an HER2 inhibitor
Experimental: H6-2 If patients were HER2+	Drug: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC) Drug: Pertuzumab Pertuzumab Drug: HRS-4508 an HER2 inhibitor
Experimental: L10 If patients were HR+HER2-	Drug: Cyclophosphamide Cyclophosphamide Drug: Nab paclitaxel Albumin paclitaxel Drug: Epirubicin Epirubicin Drug: JS207 an anti-PD-1/VEGF bispecific antibody
Experimental: H8-1 If patients were HR+HER2+	Drug: Goserelin goserelin Drug: Letrozole letrozole Drug: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC) Drug: HRS-6209 an oral cyclin-dependent kinases 4 (CDK4) inhibitor
Experimental: H8-2 If patients were HR+HER2+	Drug: Goserelin goserelin Drug: Letrozole letrozole Drug: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC)
Experimental: TN10 If patients were TNBC	Drug: JS207 an anti-PD-1/VEGF bispecific antibody Drug: 9MW2821 a Nectin-4 antibody-drug conjugate (ADC)
Experimental: L11 If patients were HR+HER2-	Drug: JS207 an anti-PD-1/VEGF bispecific antibody Drug: 9MW2821 a Nectin-4 antibody-drug conjugate (ADC)
Experimental: H9 If patients were HER2+	Drug: paclitaxel paclitaxel Drug: Trastuzumab Trastuzumab Drug: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC) Drug: Pertuzumab Pertuzumab
Experimental: H10 If patients were HER2+	Drug: Pertuzumab Pertuzumab Drug: IBI354 an anti-HER2 ADC
Experimental: TN6-3 TNBC	Drug: Nab paclitaxel Albumin paclitaxel Drug: Carboplatin Carboplatin Drug: SHR-1316 an anti-programmed death ligand 1 (PD-L1) antibody Drug: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC)
Experimental: TN11-1: TNBC patients predicted sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AI 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.	Drug: paclitaxel paclitaxel Drug: Carboplatin Carboplatin Drug: Camrelizumab an anti-programmed death-1 (PD1) antibody Other Names: SHR-1210 Drug: Famitinib tyrosine kinase inhibitors
Experimental: TN11-2: TNBC patients predicted non-sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AI 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.	Drug: paclitaxel paclitaxel Drug: Carboplatin Carboplatin Drug: Camrelizumab an anti-programmed death-1 (PD1) antibody Other Names: SHR-1210 Drug: Famitinib tyrosine kinase inhibitors Radiation: 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.
Experimental: L12 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.	Drug: Cyclophosphamide Cyclophosphamide Drug: paclitaxel paclitaxel Drug: Camrelizumab an anti-programmed death-1 (PD1) antibody Other Names: SHR-1210 Drug: Epirubicin Epirubicin Drug: Famitinib tyrosine kinase inhibitors Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological complete response rate (pCR) Time Frame: through study completion, up to 24 weeks	Pathological complete response rate	through study completion, up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
invasive disease-free survival (iDFS) Time Frame: Three-year Post-surgery Follow-up	To determine three-year invasive disease-free survival (iDFS) among the treatment arms	Three-year Post-surgery Follow-up
Overall response rate (ORR) Time Frame: up to 24 weeks	Complete response (CR) + partial response (PR)	up to 24 weeks
CTCAE scale (V4.0) Time Frame: 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)	through study completion, an average of 1 year
Evaluate gene expression profile during treatment Time Frame: through study completion, up to 24 weeks	To measure gene expression profile of baseline and sequential tumor samples during treatment, through RNA-seq platform	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	To measure number of peripheral blood mononuclear cells (PBMC) count from baseline and sequential blood samples during treatment, through Flow CytoMetry platform	through study completion, up to 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker analysis Time Frame: through study completion, up to 24 weeks	Tumor tissues, paracancerous tissues, ctDNA, blood, fecal samples, tumor pathological whole slide images and MRI images collected from study participants will be used for discovering exploratory biomarkers. The associations between these biomarkers and treatment responses disease status will be investigated.	through study completion, up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

Principal Investigator: Zhimin Shao, Professor, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

September 25, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 17, 2022

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

FASCINATE-N

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Eisai Inc.

Completed

A Study of ZYC300 Administered With Cyclophosphamide Pre-Dosing

Breast Cancer | Ovarian Cancer | Prostate Cancer | Colon Cancer | Renal Cancer

United States

Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)