NCT05205200

Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02

Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 338 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.

Detailed description

Patients with SNF2 subtype of HR+/HER2- advanced breast cancer confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital are planned to be enrolled. Five treatment arms were set up based on the whether they have exposed to CDK4/6 inhibitors before. The main purpose is to evaluate immune therapy in SNF2 subtype of HR+/HER2- advanced breast cancer and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.

Conditions

• Breast Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	SHR-1316	PD-L1 antibody
DRUG	SHR6390	CDK4/6 inhibitor
DRUG	Nab paclitaxel	Albumin bound paclitaxel
DRUG	SERD	Fulvestrant
DRUG	AI	aromatase inhibitor

Timeline

• Start date: 2022-06-06
• Primary completion: 2025-02-01
• Completion: 2026-08-01
• First posted: 2022-01-25
• Last updated: 2024-02-08

Locations

1 site across 1 country: China