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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
71
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.
Henan cacer hospital
Henan, Henan, China
RECRUITINGpathologic complete response
The proportion of patients in this group who achieved pCR after surgery after neoadjuvant therapy
Time frame: Immediately after surgery
Adverse event occurrence
The incidence and severity of adverse events (including serious adverse events)
Time frame: At the end of one Cycle (each cycle is 28 days)
objective response rate
The proportion of patients who achieved CR or PR before surgery after neoadjuvant therapy among all subjects
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Residual cancer burden
Proportion of patients with residual cancer burden score of 0-1 after surgery
Time frame: Immediately after surgery
Event free survival
The time interval between enrollment and the first recording of related events, including preoperative disease progression, postoperative disease recurrence, and death from any cause.
Time frame: 5 years after surgery
Disease free survival
The time interval between the first day without disease (surgery date) and the first recording of related events, including postoperative disease recurrence and death from any cause.
Time frame: 5 years after surgery
Distant disease/recurrence free survival
The time interval between the first day without disease ( surgery date) and the first occurrence of distant recurrence.
Time frame: 5 years after surgery
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