RecruitingNCT05578053

Efficacy and Safety of Dalpiciclib in Hormone Receptor-positive Advanced Breast Cancer

Efficacy and Safety of Dalpiciclib in Hormone Receptor-positive Advanced Breast Cancer: a Multicenter, Observational, Real-world Study


Sponsor

Hebei Medical University Fourth Hospital

Enrollment

420 participants

Start Date

Sep 13, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This study is a multi-center, observational, real-world study. We planned to recruit 420 HR+ locally advanced or metastatic breast cancer patients who had received or had not received prior systemic therapy. All patients included in the analysis were receiving or planning to receive dalpiciclib-containing regimens without restrictions, completely following the physician 's clinical choice, to assess the efficacy and safety of dalpiciclib-containing regimens.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called dalpiciclib, combined with hormone-blocking therapy, can help treat hormone receptor-positive (HR+) breast cancer that has spread or come back and cannot be removed with surgery. **You may be eligible if...** - You are 18 or older - You have HR-positive breast cancer that has spread to other parts of the body or returned after treatment - Your cancer cannot be cured by surgery or radiation - You are male or female (women can be pre- or post-menopausal) - You are in good enough health to participate (able to carry out daily activities) - You have a negative pregnancy test if you can become pregnant, and are willing to use birth control **You may NOT be eligible if...** - You have a serious uncontrolled illness (like uncontrolled high blood pressure, active infection including hepatitis B/C or HIV, or major organ damage) - You still have significant side effects (grade 3 or higher) from previous cancer treatment - You are allergic to dalpiciclib or similar drugs - You are currently 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

DRUGDalpiciclib

a new, orally administered, selective CDK4/6 inhibitor


Locations(1)

The Fourth hospital of Hebei University

Shijiazhuang, Hebei, China

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NCT05578053


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