Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Anti-Infective Agents

Amino Acids

Paclitaxel

Albumin-Bound Paclitaxel

Trastuzumab

Pertuzumab

Carboplatin

Antibodies

Androgens

Cyclophosphamide

Hormones

Letrozole

Epirubicin

Fluzoparib

Immunoglobulins

Goserelin

Adenosine

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antineoplastic Agents, Hormonal

Poly(ADP-ribose) Polymerase Inhibitors

Tyrosine

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

If patients were HR+HER2- with SNF1 subtype

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

If patients were HR+HER2- with SNF2 subtype

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

If patients were HR+HER2- with SNF3 subtype

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

If patients were HR+HER2- with SNF4 subtype

If patients were HR+HER2-low with SNF4 subtype

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

If patients were triple-negative breast cancer with IM subtype

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

If patients were triple-negative breast cancer with BLIS subtype

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

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

If patients were triple-negative breast cancer with other subtypes

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

Dalpiciclib

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

Pyrotinib

an anti-HER2 antibody-drug conjugate (ADC)

SHR-A1811

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

SHR-1316

an anti-programmed death-1 (PD1) antibody

Camrelizumab

Trophoblast cell-surface antigen 2 (TROP2) ADC

Nab paclitaxel

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

HER2 ADC

Zhimin Shao, Professor

Zhimin Shao, M.D.

Min He, M.D

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.

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.

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

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

To determine three-year invasive disease-free survival (iDFS) among the treatment arms

Complete response (CR) + partial response (PR)

4) To evaluate the rate of adverse effects of patient by the standard CTCAE scale (V4.0)

To measure gene expression profile of baseline and sequential tumor samples during treatment, through RNA-seq platform

To measure number of peripheral blood mononuclear cells (PBMC) count from baseline and sequential blood samples during treatment, through Flow CytoMetry platform

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy	NCT05582499	Breast Neoplasm Breast Cancer Breast Tumors Triple-Negative... HER2-positive B... HER2-negative B... Hormone Recepto... Hormone Recepto... Early-stage Bre... Locally Advance...	Dalpiciclib Pyrotinib SHR-A1811 SHR-1316 Camrelizumab Trophoblast cel... Pertuzumab Trastuzumab Goserelin Letrozole Nab paclitaxel Carboplatin Epirubicin Cyclophosphamid... Fluzoparib HER2 ADC	18 Years - 70 Years	Fudan University
Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy	NCT05582499	Breast Neoplasm Breast Cancer Breast Tumors Triple-Negative... HER2-positive B... HER2-negative B... Hormone Recepto... Hormone Recepto... Early-stage Bre... Locally Advance...	Dalpiciclib Pyrotinib SHR-A1811 SHR-1316 Camrelizumab Trophoblast cel... Pertuzumab Trastuzumab Goserelin Letrozole Nab paclitaxel Carboplatin Epirubicin Cyclophosphamid... Fluzoparib HER2 ADC	18 Years - 70 Years	Fudan University

Spots Global Cancer Trial Database for her2 adc

Every month we try and update this database with for her2 adc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for her2 adc

Every month we try and update this database with for her2 adc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for her2 adc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.