RecruitingPhase 2NCT05594095

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

Precision Platform Study of HR+/ HER2-advanced Breast Cancer Based on SNF Typing (A Prospective, Open-label, Multi-center, Phase II Platform Study)


Sponsor

Fudan University

Enrollment

620 participants

Start Date

Dec 30, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is an umbrella trial for women with advanced or metastatic breast cancer that is hormone receptor-positive and HER2-negative, whose cancer progressed after prior treatment with CDK4/6 inhibitors (a common targeted therapy). It tests various drug combinations tailored to each patient's tumor profile. **You may be eligible if...** - You are a woman 18 years or older - You have HR+/HER2- breast cancer confirmed by biopsy (hormone receptor-positive, HER2-negative) - Your cancer has spread locally or to other organs and cannot be surgically cured - Your cancer progressed on or after treatment with a CDK4/6 inhibitor drug **You may NOT be eligible if...** - You received chemotherapy or immunotherapy within the last 3 weeks - You have uncontrolled brain metastases - You have a history of serious heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPIK3CA inhibitor

PIK3CA inhibitor

DRUGAKT inhibitor

AKT inhibitor

DRUGCarrelizumab

Pd-1 mab

DRUGFamitinib

VEGFR inhibitor

DRUGFluzoparib

PARP inhibitor

DRUGDalpiciclib

CDK4/6 inhibitor

DRUGSHR-A1811

HER2 ADC

DRUGEverolimus

mTOR inhibior

DRUGAromatase Inhibitors or Fulvestrant

Letrozole/Anastrozole/Exemestane or Fulvestrant

DRUGGoserelin

For premenopause

DRUGTPC

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

DRUGSorafenib

RTK Inhibitor

DRUGApatinib

Apatinib 250mg po qd

DRUGSHR-A1921

TROP2 ADC

DRUGSHR-A2102

NECTIN4 ADC

DRUGSHR-A2009

HER3 ADC

DRUGSHR-1167

PARP1i

DRUGSHR-6209

CDK4i

DRUGbevacizumab

bevacizumab


Locations(1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

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NCT05594095


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