NCT04355858

Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer

Precision Treatment of Luminal Advanced Breast Cancer Based on Molecular Subtyping

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 319 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single-center, open-label, umbrella-shaped phase II clinical study for patients with HR+/HER2- endocrine-resistant advanced breast cancer.

Detailed description

Seven precision treatment cohorts, which targeting NF1 mutation, gBRCA mutation,HER2 mutation, FDGFRb mutation PAM pathway mutations, CD8 and AR, as long as an epigenetic therapy cohort and a combined immunization cohort were initially set up based on gene expression profiles and molecular pathways. The main purpose is to screen valuable treatment cohorts and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.

Conditions

• Breast Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	SHR7390	MEK1/2 inhibitor
DRUG	Famitinib	Multi-target tyrosine kinase inhibitor
DRUG	SHR3162	PARP inhibitor
DRUG	Pyrotinib	HER1 / HER2 receptor tyrosine kinase inhibitor
DRUG	Capecitabine	In Arm III, if the patient had not previously used capecitabine,she would receive pyrotinib and capecitabine, if the patients have previously used capecitabine, she would only used pyrotinib as a single agent.
DRUG	SHR1210	PD-1 antibody
DRUG	Everolimus	mTOR inhibitor
DRUG	Nab paclitaxel	Albumin bound paclitaxel
DRUG	SHR2554	EZH2 inhibitor
DRUG	SHR3680	AR inhibitor
DRUG	SHR6390	CDK4/6 inhibitor
DRUG	SHR1701	anti-PD-L1/TGF-βRII bifunctional fusion protein
DRUG	SERD	Fulvestrant
DRUG	AI	aromatase inhibitor
DRUG	VEGFi	Bevacizumab

Timeline

• Start date: 2020-05-01
• Primary completion: 2023-05-01
• Completion: 2025-04-01
• First posted: 2020-04-21
• Last updated: 2022-07-26

Locations

1 site across 1 country: China