NCT05594095

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 620 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants in this study were hormone-receptor-positive HER2-negative patients with advanced breast cancer who had previously used CDK4/6 inhibitors. Hormone receptor positive HER2 negative was defined as ER positive (IHC ER positive percentage \> 10% or PR positive (IHC PR positive percentage \> 10%) and HER2 negative (IHC-/+; Or IHC++ but FISH/CISH-). The Department of Pathology and the Key Laboratory of Breast Cancer of Fudan University Shanghai Cancer Center conducted digital pathological typing of the biopsy pathology of metastatic lesions of all participants . If the pathology of metastatic lesions could not be obtained, the digital pathological typing was performed according to the pathology of primary lesions. According to the digital pathological types of biopsy tissue and peripheral blood ctDNA, the patients were divided into four precise subtypes: SNF1, SNF2, SNF3, and SNF4. At the same time, the negative control group was randomly set by subtype stratification at 2:1. In different SNF types, patients were divided into 7 subcohorts according to the genetic PANEL results.

Conditions

• Breast Neoplasm
• Breast Cancer
• Hormone Receptor Positive Tumor
• HER2-negative Breast Cancer
• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	PIK3CA inhibitor	PIK3CA inhibitor
DRUG	AKT inhibitor	AKT inhibitor
DRUG	Carrelizumab	Pd-1 mab
DRUG	Famitinib	VEGFR inhibitor
DRUG	Fluzoparib	PARP inhibitor
DRUG	Dalpiciclib	CDK4/6 inhibitor
DRUG	SHR-A1811	HER2 ADC
DRUG	Everolimus	mTOR inhibior
DRUG	Aromatase Inhibitors or Fulvestrant	Letrozole/Anastrozole/Exemestane or Fulvestrant
DRUG	Goserelin	For premenopause
DRUG	TPC	Treatment of Physicians' Choice (albumin-paclitaxel, capecitabine, vinorelbine, and irbribulin)
DRUG	Sorafenib	RTK Inhibitor
DRUG	Apatinib	Apatinib 250mg po qd
DRUG	SHR-A1921	TROP2 ADC
DRUG	SHR-A2102	NECTIN4 ADC
DRUG	SHR-A2009	HER3 ADC
DRUG	SHR-1167	PARP1i
DRUG	SHR-6209	CDK4i
DRUG	bevacizumab	bevacizumab

Timeline

• Start date: 2022-12-30
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2022-10-26
• Last updated: 2024-10-04

Locations

1 site across 1 country: China