RecruitingPhase 2NCT06341894

Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer

Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

1,163 participants

Start Date

Nov 17, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding dalpiciclib (a drug that slows cancer cell growth by targeting specific proteins) to standard hormone therapy reduces the risk of early-stage breast cancer coming back in women with hormone receptor-positive, HER2-negative breast cancer. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of hormone receptor-positive, HER2-negative early breast cancer - Your cancer is stage IIA to IIIC - You have had surgery and your enrollment is within 12 months of the operation - Your general health status is good (ECOG 0 or 1) - You are pre-, peri-, or post-menopausal (menopausal status must be known) **You may NOT be eligible if...** - Your cancer has spread to other parts of the body (stage IV) or is inflammatory breast cancer - You have a history of another cancer (except certain cured skin or cervical cancers) - You have significant heart disease - You have a history of allergic reactions to the drugs in this study - You cannot swallow tablets - You have gastrointestinal disease with significant diarrhea 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDalpiciclib

CDK4/6 inhibitor dalpiciclib, 100mg orally qd

DRUGEndocrine therapy

Fulvestrant/AI


Locations(1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06341894


Related Trials