Current partner codePEPTIDESDE
NCT05582499·Phase 2·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 2

Enrollment

716

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Dalpiciclib

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

DRUG

Pyrotinib

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

DRUG

SHR-A1811

an anti-HER2 antibody-drug conjugate (ADC)

DRUG

SHR-1316

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

DRUG

Camrelizumab

an anti-programmed death-1 (PD1) antibody

DRUG

SHR-A1921

Trophoblast cell-surface antigen 2 (TROP2) ADC

DRUG

Pertuzumab

Pertuzumab

DRUG

Trastuzumab

Trastuzumab

DRUG

Goserelin

goserelin

DRUG

Letrozole

letrozole

DRUG

Nab paclitaxel

Albumin paclitaxel

DRUG

Carboplatin

Carboplatin

Timeline

From registration to results.

  1. First posted

    Oct 17, 2022

  2. Study start

    Nov 1, 2022

  3. Primary completion

    Dec 31, 2027

  4. Study completion

    Sep 2029

  5. Results posted

    Not reported

  6. Registry updated

    May 28, 2026

Outcomes

What the study measures.

Primary outcomes

Pathological complete response rate (pCR)

Time frame · through study completion, up to 24 weeks

Pathological complete response rate

Secondary outcomes

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

Overall response rate (ORR)

Time frame · up to 24 weeks

Complete response (CR) + partial response (PR)

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)

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

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
FEMALE
Healthy volunteers
No

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 locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Fudan University Shanghai Cancer Center Shanghai, China, 200032

Shanghai, Shanghai Municipality, China

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