Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02
NCT05205200 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 338
Last updated 2024-02-08
Summary
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
Conditions
Interventions
- DRUG
-
SHR-1316
PD-L1 antibody
- DRUG
-
SHR6390
CDK4/6 inhibitor
- DRUG
-
Nab paclitaxel
Albumin bound paclitaxel
- DRUG
-
SERD
Fulvestrant
- DRUG
-
AI
aromatase inhibitor
Sponsors & Collaborators
-
Peking University Cancer Hospital & Institute
collaborator OTHER -
First Hospital of China Medical University
collaborator OTHER -
Sun Yat-sen University
collaborator OTHER -
First Affiliated Hospital Xi'an Jiaotong University
collaborator OTHER -
Liaoning Cancer Hospital & Institute
collaborator OTHER -
Chongqing University Cancer Hospital
collaborator OTHER -
Northern Jiangsu People's Hospital
collaborator OTHER -
Fujian Medical University Union Hospital
collaborator OTHER -
Ningbo Medical Center Lihuili Hospital
collaborator OTHER_GOV -
Shanghai First Maternity and Infant Hospital
collaborator OTHER -
Shanghai 6th People's Hospital
collaborator OTHER -
Affiliated Hospital of Nantong University
collaborator OTHER -
Fudan University
lead OTHER
Principal Investigators
-
Zhi-Ming Shao · Fudan University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-06
- Primary Completion
- 2025-02-01
- Completion
- 2026-08-01
Countries
- China
Study Locations
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