Culmerciclib Combined With Letrozole and Dual HER2 Blockade as Neoadjuvant Therapy for HR+/HER2+ Breast Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Breast Pathological Complete Response Rate (bpCR) — At time of surgery, after completion of 5 cycles of neoadjuvant therapy (approximately 5 months from treatment start)
  Proportion of patients achieving ypT0/is ypN0 (no invasive cancer in the breast and no involved axillary lymph nodes), assessed by postoperative pathology.

Trial sites (1)

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