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Culmerciclib Combined With Letrozole and Dual HER2 Blockade as Neoadjuvant Therapy for HR+/HER2+ Breast Cancer
Sponsor: Shengjing Hospital
Summary
This is a single-arm, prospective, multicenter, phase II clinical study evaluating the efficacy and safety of a chemotherapy-free neoadjuvant regimen in patients with HR-positive/HER2-positive (HR+/HER2+) early or locally advanced breast cancer. Approximately 33 treatment-naive patients with stage II-III (AJCC 8th edition) HR+/HER2+ breast cancer will receive 5 cycles of neoadjuvant treatment with culmerciclib (a CDK4/6 inhibitor) plus letrozole, trastuzumab (TQB211) and pertuzumab (TQB2440), followed by definitive breast surgery. The primary endpoint is breast pathological complete response rate (bpCR, ypT0/is ypN0). Secondary endpoints include objective response rate (ORR), residual cancer burden (RCB), Ki67 change rate, patient-reported outcomes, and safety assessed per CTCAE v5.0.
Official title: A Single-Arm, Prospective, Multicenter Phase II Study of Culmerciclib Plus Letrozole and Trastuzumab (TQB211)/Pertuzumab (TQB2440) as Neoadjuvant Therapy in Patients With HR-Positive/HER2-Positive Early or Locally Advanced Breast Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
33
Start Date
2026-09-01
Completion Date
2028-06-30
Last Updated
2026-08-31
Healthy Volunteers
No
Interventions
Culmerciclib
180 mg orally once daily, in 28-day cycles, for a total of 5 cycles.
Letrozole
2.5 mg orally once daily, in 28-day cycles, for a total of 5 cycles.
Trastuzumab (TQB211)
8 mg/kg intravenous loading dose, followed by 6 mg/kg intravenously every 3 weeks, for a total of 6 doses.
Pertuzumab (TQB2440)
840 mg intravenous loading dose, followed by 420 mg intravenously every 3 weeks, for a total of 6 doses
Locations (1)
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China