RecruitingPhase 3NCT06447623

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

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)

Sponsor

Fudan University

Enrollment

184 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Advanced Breast Cancer HR+/HER2- Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of two targeted cancer drugs — apatinib (which blocks blood vessel growth to tumors) and a CDK4/6 inhibitor (which slows cancer cell division) — as a first treatment for a specific subtype of hormone receptor-positive, HER2-negative advanced breast cancer. **You may be eligible if...** - You are between 18 and 75 years old - You have hormone receptor-positive (HR+), HER2-negative breast cancer that is locally advanced or has spread to other parts of the body - Your cancer has been confirmed as the SNF4 subtype through pathology - You have not received prior systemic therapy for advanced disease **You may NOT be eligible if...** - You have already been treated with a CDK4/6 inhibitor or apatinib - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGApatinib

Apatinib is a kind of TKI inhibitor.

DRUGCDK4/6 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.

DRUGAromatase 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

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NCT06447623

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