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

ConditionsBreast NeoplasmBreast CancerBreast TumorsTriple-Negative Breast Cancer (TNBC)HER2-positive Breast CancerHER2-negative Breast CancerHormone Receptor Positive TumorHormone Receptor Negative TumorEarly-stage Breast CancerLocally Advanced Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dalpiciclib

    Drug

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

  • Pyrotinib

    Drug

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

  • SHR-A1811

    Drug

    an anti-HER2 antibody-drug conjugate (ADC)

  • SHR-1316

    Drug

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

  • Camrelizumab

    Drug

    an anti-programmed death-1 (PD1) antibody

  • SHR-A1921

    Drug

    Trophoblast cell-surface antigen 2 (TROP2) ADC

  • Pertuzumab

    Drug

    Pertuzumab

  • Trastuzumab

    Drug

    Trastuzumab

  • Goserelin

    Drug

    goserelin

  • Letrozole

    Drug

    letrozole

  • Nab paclitaxel

    Drug

    Albumin paclitaxel

  • Carboplatin

    Drug

    Carboplatin

  • Epirubicin

    Drug

    Epirubicin

  • Cyclophosphamide

    Drug

    Cyclophosphamide

  • Fluzoparib

    Drug

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

  • Apatinib

    Drug

    tyrosine kinase inhibitors

  • Famitinib

    Drug

    tyrosine kinase inhibitors

  • HB1801

    Drug

    Albumin docetaxel

  • LEM

    Drug

    liposome-entrapped mitoxantrone

  • TQB2102

    Drug

    an anti-HER2 ADC

  • Benmelstobart

    Drug

    an anti-PDL1 antibody

  • Anlotinib

    Drug

    an tyrosine kinase inhibitor

  • TQB2868

    Drug

    anti-PD-1/TGF-βRII

  • Ivonescimab

    Drug

    an anti-PD-1/VEGF bispecific antibody

  • JS207

    Drug

    an anti-PD-1/VEGF bispecific antibody

  • JSKN003

    Drug

    an anti-HER2 ADC

  • HRS-4508

    Drug

    an HER2 inhibitor

  • SHR-4602

    Drug

    an anti-HER2 ADC

  • paclitaxel

    Drug

    paclitaxel

  • HRS-6209

    Drug

    an oral cyclin-dependent kinases 4 (CDK4) inhibitor

  • 9MW2821

    Drug

    a Nectin-4 antibody-drug conjugate (ADC)

  • IBI354

    Drug

    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.

Treatment groups

716 Participants
are divided into 63 treatment groups

63

Treatment groups

See each treatment group below.

Group A: L1-1Experimental treatment 3 interventions
Group B: L1-2Active comparator 2 interventions
Group C: L2-2Active comparator 2 interventions
Group D: L3-2Active comparator 2 interventions
Group E: L4-2Active comparator 2 interventions
Group F: L4-low-1Experimental treatment 1 intervention
Group G: L4-low-2Active comparator 2 interventions
Group H: TN1-1Experimental treatment 5 interventions
Group I: TN1-2Active comparator 4 interventions
Group J: TN2-1Experimental treatment 5 interventions
Group K: TN2-2Active comparator 4 interventions
Group L: TN3-1Experimental treatment 5 interventions
Group M: TN3-2Active comparator 4 interventions
Group N: TN4-1.1Experimental treatment 1 intervention
Group O: TN4-2Active comparator 4 interventions
Group P: TN5-1.1Experimental treatment 1 intervention
Group Q: TN5-2Active comparator 4 interventions
Group R: H1-1.1Experimental treatment 2 interventions
Group S: H1-2Active comparator 4 interventions
Group T: H2-1.1Experimental treatment 1 intervention
Group U: H2-2Active comparator 4 interventions
Group V: L2-1.2Experimental treatment 3 interventions
Group W: L3-1.2Experimental treatment 3 interventions
Group X: L4-1.2Experimental treatment 3 interventions
Group Y: TN5-1.2Experimental treatment 2 interventions
Group Z: H1-1.2Experimental treatment 1 intervention
Group [: H2-1.2Experimental treatment 2 interventions
Group \: TN4-1.2Experimental treatment 3 interventions
Group ]: L2-1.1Experimental treatment 3 interventions
Group ^: L2-1.3Experimental treatment 4 interventions
Group _: L3-1.1Experimental treatment 3 interventions
Group `: L4-1.1Experimental treatment 1 intervention
Group a: L5-1Experimental treatment 3 interventions
Group b: L5-2Experimental treatment 3 interventions
Group c: L6Experimental treatment 3 interventions
Group d: L7Experimental treatment 3 interventions
Group e: L8Experimental treatment 3 interventions
Group f: L9Experimental treatment 5 interventions
Group g: TN6-1Experimental treatment 3 interventions
Group h: TN6-2Experimental treatment 2 interventions
Group i: TN7-1Experimental treatment 2 interventions
Group j: TN7-2Experimental treatment 3 interventions
Group k: TN8Experimental treatment 2 interventions
Group l: TN9Experimental treatment 4 interventions
Group m: H3Experimental treatment 1 intervention
Group n: H4-1Experimental treatment 5 interventions
Group o: H4-2Experimental treatment 1 intervention
Group p: H4-3Experimental treatment 4 interventions
Group q: H4-4Experimental treatment 2 interventions
Group r: H5Experimental treatment 2 interventions
Group s: H6-1Experimental treatment 2 interventions
Group t: H6-2Experimental treatment 3 interventions
Group u: L10Experimental treatment 4 interventions
Group v: H8-1Experimental treatment 4 interventions
Group w: H8-2Experimental treatment 3 interventions
Group x: TN10Experimental treatment 2 interventions
Group y: L11Experimental treatment 2 interventions
Group z: H9Experimental treatment 4 interventions
Group {: H10Experimental treatment 2 interventions
Group |: TN6-3Experimental treatment 4 interventions
Group }: TN11-1: TNBC patients predicted sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AIExperimental treatment 4 interventions
Group ~: TN11-2: TNBC patients predicted non-sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AIExperimental treatment 5 interventions
Group : L12Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Pathological complete response rate (pCR)

Pathological complete response rate

Time frame
through study completion, up to 24 weeks

Secondary outcomes

1

invasive disease-free survival (iDFS)

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

Time frame
Three-year Post-surgery Follow-up
2

Overall response rate (ORR)

Complete response (CR) + partial response (PR)

Time frame
up to 24 weeks
3

CTCAE scale (V4.0)

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

Time frame
through study completion, an average of 1 year
4

Evaluate gene expression profile during treatment

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

Time frame
through study completion, up to 24 weeks

Other outcomes

1

Biomarker analysis

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.

Time frame
through study completion, up to 24 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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