Clinical trial · Interventional
Culmerciclib Combined With Letrozole and Dual HER2 Blockade as Neoadjuvant Therapy for HR+/HER2+ Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| HR Positive, HER2 Positive Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Culmerciclib | Drug | — | UNRESOLVED |
| Letrozole | Drug | Letrozole | ALIAS |
| Pertuzumab (TQB2440) | Drug | Pertuzumab | ALIAS |
| Trastuzumab (TQB211) | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Culmerciclib + Letrozole + TQB211 + TQB2440
- description
- Patients receive Culmerciclib plus letrozole, trastuzumab (TQB211) and pertuzumab (TQB2440) as neoadjuvant therapy for 5 cycles, followed by definitive breast cancer surgery.
- interventionNames
- Drug: Culmerciclib
- Drug: Letrozole
- Drug: Trastuzumab (TQB211)
- Drug: Pertuzumab (TQB2440)
Primary outcomes (1)
- measure
- Breast Pathological Complete Response Rate (bpCR)
- timeFrame
- At time of surgery, after completion of 5 cycles of neoadjuvant therapy (approximately 5 months from treatment start)
- description
- Proportion of patients achieving ypT0/is ypN0 (no invasive cancer in the breast and no involved axillary lymph nodes), assessed by postoperative pathology.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed HR-positive (ER \>=50%, PR \>=10%) and HER2-positive (IHC 3+ or ISH+) breast cancer; * Clinical stage II-III (AJCC 8th edition); * Treatment-naive: no prior systemic anti-tumor therapy for breast cancer; * ECOG performance status 0-1; * Adequate organ function; * Signed informed consent. Exclusion Criteria: * Distant metastasis (stage IV disease); * Prior chemotherapy, endocrine therapy, or anti-HER2 therapy for the current breast cancer; * Severe cardiac dysfunction or left ventricular ejection fraction (LVEF) below the institutional lower limit of normal; * Pregnancy or lactation; * Any other condition that, in the investigator's opinion, makes the patient unsuitable for the study.
References
Publications (0)
Data not yet available