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

Sponsor
Henan Cancer Hospital
Study ID
NCT06276868
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Dalcilib+letrozole+HP treatment group — DRUG
    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.

Study Details

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.

Key Dates

First listed
Feb 26, 2024
Start date
Jan 20, 2024
Status verified
Nov 2024
Primary completion
Jul 1, 2025
Completion
Jun 1, 2029

Study Design

Enrollment
71 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dalcilib+letrozole+HP
    All subjects received Dalcilib 150mg qd, stopped for 1 week after 3 weeks，and letrozole (2.5mg qd) (premenopausal combined with OFS). The subjects received 2 cycles of preoperative treatment with darcilib combined with letrozole, trastuzumab, and patstuzumab. Then, MRI efficacy evaluation will be conducted, and patients who achieved PR continue to receive the original treatment regimen for 6 cycles, while those who did not achieve PR switched to the TCHP chemotherapy regimen for 6 cycles.

Primary Outcome Measure

pathologic complete response [ Time Frame: Immediately after surgery ]

Central Contacts

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