RecruitingPhase 2NCT06276868

Darsilide Combined With AI, Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HR+/HER2+ Breast Cancer

A Clinical Study of Darsilide Combined With AI, Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HR Positive HER2 Positive Breast Cancer

Sponsor

Henan Cancer Hospital

Enrollment

71 participants

Start Date

Jan 20, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer HER2-positive Breast Cancer

Summary

This study is intended to carry out a single arm, prospective, open clinical study, and use Darsilide combined with endocrine therapy, Trastuzumab and Patuzumab to treat early or locally advanced breast cancer of TPBC before surgery. It is intended to further explore the efficacy and safety of the new adjuvant treatment for TPBC patients with step-down therapy.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug combination before surgery (neoadjuvant treatment) for women with early-stage breast cancer that is both hormone receptor-positive and HER2-positive. The combination includes a CDK inhibitor called darsilide plus hormone-blocking therapy and two HER2-targeting drugs (trastuzumab and pertuzumab). **You may be eligible if...** - You are a woman between 18 and 70 years old with no prior treatment for this cancer - Your breast cancer is confirmed as invasive, hormone receptor-positive, and HER2-positive - Your cancer is Stage II to IIIA - Your heart, liver, kidney, and blood counts are within acceptable ranges - You agree to use effective contraception during and for at least 7 months after treatment **You may NOT be eligible if...** - Your cancer has spread to other parts of the body (Stage IV/metastatic) - You have inflammatory breast cancer - You have received prior anti-cancer therapy for any malignancy - You have significant heart problems 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

DRUGDalcilib+letrozole+HP treatment group

All participants received 150mg of darcilib once a day. Take it continuously for 21 days, then stop taking it for 7 days, with a treatment cycle of 28 days. Letrozole 2.5mg once daily (premenopausal patients treated with OFS); Trastuzumab (8mg/kg first dose, 6mg/kg sequential) and Patuzumab (840mg first dose, 420mg/kg sequential) were administered intravenously every 3 weeks, or fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (1200 mg pertuzumab plus 600 mg trastuzumab loading dose in 15 mL, followed by 600 mg pertuzumab plus 600 mg trastuzumab maintenance doses in 10 mL), both administered every 3 weeks.

Locations(1)

Henan cacer hospital

Henan, Henan, China

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NCT06276868

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