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SNF Platform Study of HR+/ HER2-advanced Breast Cancer

ConditionsBreast NeoplasmBreast CancerHormone Receptor Positive TumorHER2-negative Breast CancerAdvanced Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFudan University

About this trial

The purpose of this study is to establish a prospective, multi-center platform research based on clinical subtypes to explore precision therapy in patients hormone-receptor-positive HER2-negative advanced breast cancer who had previously used CDK4/6 inhibitors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female aged ≥18 years;

HR+/HER2- invasive breast cancer confirmed by histology (specific definition: ER >10% positive tumor cells by immunohistochemistry is defined as ER positive, PR >10% positive tumor cells is defined as PR positive, ER and/or PR positive is defined as HR positive; HER2 0-1+ or HER2 + but negative by FISH without amplification was defined as HER2 negative);

Locally advanced breast cancer (unable to undergo radical local treatment) or recurrent metastatic breast cancer;

HR+/HER2- advanced breast cancer patients who had previously received CDK4/6 inhibitor therapy;

Disqualifiers

Radiotherapy (except for palliative causes), chemotherapy, and immunotherapy were used in the first 3 weeks of treatment, except bisphosphonate (which can be used for bone metastasis);

Uncontrolled central nervous system metastases (indicating symptomatic or symptomatic treatment with glucocorticoids or mannitol);

A history of clinically important or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmia within the last 6 months;

Persistent grade 1 or higher adverse reactions caused by previous treatments. The exception to this is hair loss or something the researchers don't think should be ruled out. Such cases should be clearly documented in the investigator's notes;

Trial design

Design model

Parallel

Treatments tested in this trial

  • PIK3CA inhibitor

    Drug

    PIK3CA inhibitor

  • AKT inhibitor

    Drug

    AKT inhibitor

  • Carrelizumab

    Drug

    Pd-1 mab

  • Famitinib

    Drug

    VEGFR inhibitor

  • Fluzoparib

    Drug

    PARP inhibitor

  • Dalpiciclib

    Drug

    CDK4/6 inhibitor

  • SHR-A1811

    Drug

    HER2 ADC

  • Everolimus

    Drug

    mTOR inhibior

  • Aromatase Inhibitors or Fulvestrant

    Drug

    Letrozole/Anastrozole/Exemestane or Fulvestrant

  • Goserelin

    Drug

    For premenopause

  • TPC

    Drug

    Treatment of Physicians' Choice (albumin-paclitaxel, capecitabine, vinorelbine, and irbribulin)

  • Sorafenib

    Drug

    RTK Inhibitor

  • Apatinib

    Drug

    Apatinib 250mg po qd

  • SHR-A1921

    Drug

    TROP2 ADC

  • SHR-A2102

    Drug

    NECTIN4 ADC

  • SHR-A2009

    Drug

    HER3 ADC

  • SHR-1167

    Drug

    PARP1i

  • SHR-6209

    Drug

    CDK4i

  • bevacizumab

    Drug

    bevacizumab

Treatment groups

620 Participants
are divided into 26 treatment groups

26

Treatment groups

See each treatment group below.

Group A: SNF1 1A: PIK3CA mutationExperimental treatment 3 interventions
Group B: SNF1 1B: AKT pathway mutationExperimental treatment 3 interventions
Group C: SNF1 1C: without above mutationExperimental treatment 3 interventions
Group D: SNF2 2AExperimental treatment 3 interventions
Group E: SNF3 3A: Stratification of BRCA/PALB2 expressionExperimental treatment 2 interventions
Group F: SNF4 4A: HER2 lowExperimental treatment 1 intervention
Group G: The control armActive comparator 1 intervention
Group H: SNF3 3B:Experimental treatment 2 interventions
Group I: SNF4 4B:Experimental treatment 2 interventions
Group J: SNF1 1D: without above mutationExperimental treatment 2 interventions
Group K: SNF1 1E: HER2 LOWExperimental treatment 2 interventions
Group L: SNF1 1F: HER2 zeroExperimental treatment 2 interventions
Group M: SNF2 2B: HER2 zeroExperimental treatment 3 interventions
Group N: SNF2 2C:Experimental treatment 3 interventions
Group O: SNF2 2D:Experimental treatment 3 interventions
Group P: SNF2 2E: HER2 lowExperimental treatment 3 interventions
Group Q: SNF3 3C:Experimental treatment 2 interventions
Group R: SNF3 3D:Experimental treatment 2 interventions
Group S: SNF3 3E: HER2 lowExperimental treatment 2 interventions
Group T: SNF3 3F: HER2 zeroExperimental treatment 2 interventions
Group U: SNF4 4CExperimental treatment 1 intervention
Group V: SNF4 4DExperimental treatment 1 intervention
Group W: SNF4 4EExperimental treatment 1 intervention
Group X: SNF4 4F: HER2 lowExperimental treatment 2 interventions
Group Y: SNF4 4GExperimental treatment 2 interventions
Group Z: SNF4 4HExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall response rate (ORR)

The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)

Time frame
Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 3 years)

Secondary outcomes

1

Clinical Benefit Rate (CBR)

the percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the subjects

Time frame
Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 3 years
2

Progression Free Survival (PFS)

time to progressive disease (according to RECIST1.1)

Time frame
Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 3 years)]
3

Overall Survival (OS)

time to death due to any cause

Time frame
Randomization to death from any cause, through the end of study (approximately 3 years)
4

CTCAE scale (V5.0)

To evaluate the rate of adverse effects of patient by the standard CTCAE scale (V5.0)

Time frame
up to One Year during follow-up

Other outcomes

Sponsors and contacts

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

Fudan University

Lead sponsor

Peking University Cancer Hospital & Institute

Collaborator

First Hospital of China Medical University

Collaborator

Sun Yat-sen University

Collaborator

First Affiliated Hospital Xi'an Jiaotong University

Collaborator

Chongqing University Cancer Hospital

Collaborator

Northern Jiangsu People's Hospital

Collaborator

Fujian Medical University Union Hospital

Collaborator

Ningbo Medical Center Lihuili Hospital

Collaborator

Shanghai First Maternity and Infant Hospital

Collaborator

Shanghai 6th People's Hospital

Collaborator

Affiliated Hospital of Nantong University

Collaborator

Nanchang People's Hospital

Collaborator

Liaoning Cancer Hospital & Institute

Collaborator

The First Hospital of Jilin University

Collaborator

Source ClinicalTrials.gov
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