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RECRUITING
NCT06447623
PHASE3

Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

This is a randomized, controlled, open-label, phase III study to explore the efficacy and safety of Apatinib in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF4 subtype of advanced breast cancer. The study was used to explore the efficacy of Apatinib in combination with standard endocrine therapy.

Official title: Study of Efficacy of Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Advanced Breast Cancer (Open, Randomized, Phase III)

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

184

Start Date

2024-02-01

Completion Date

2029-02-01

Last Updated

2024-06-07

Healthy Volunteers

No

Interventions

DRUG

Apatinib

Apatinib is a kind of TKI inhibitor.

DRUG

CDK4/6 Inhibitor

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

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.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China