Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subtype Advanced Breast Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

265

Participants

Timeline

Start Date

July 26, 2023

Primary Completion Date

July 31, 2026

Study Completion Date

January 31, 2028

Conditions
Breast CancerAdvanced Breast Cancer
Interventions
DRUG

Everolimus 10 mg

Everolimus is a kind of mTOR inhibitor which has been approved to use in several kinds of cancers, especially in metastatic breast cancer.

DRUG

CDK4/6 Inhibitor SHR6390

Dalpiciclib (SHR6390) is a kind of CDK4/6 inhibitor that has demonstrated tolerability and preliminary clinical activity in patients with heavily pretreated hormone receptor-positive, HER2-negative advanced breast cancer.

DRUG

Aromatase inhibitor and Fulvestrant combined with CDK4/6 inhibitors

Endocrine therapy combined with CDK4/6 inhibitors is the standard first-line therapy for advanced luminal breast cancer. Investigators choose endocrine therapy including Letrozole, Anastrozole, Exemestane, and Fulvestrant. Postmenopausal participants should use Goserelin.

Trial Locations (1)

200032

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER