NCT06276868

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. 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, with all patients receiving 8 cycles of treatment. After starting treatment and before surgery, subjects will be monitored through breast MRI to evaluate clinical tumor remission. The primary endpoint was the pCR rate in the group receiving darcilib+letrozole+HP treatment, defined as the proportion of patients who achieved pCR after surgery after neoadjuvant therapy.

Conditions

• Breast Cancer
• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Dalcilib+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.

Timeline

• Start date: 2024-01-20
• Primary completion: 2025-07-01
• Completion: 2029-06-01
• First posted: 2024-02-26
• Last updated: 2024-12-17

Locations

1 site across 1 country: China