NCT07795424Not yet recruitingPhase 2
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 · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- First submitted
- 26 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Mar 2028
- Lead sponsor
- Shengjing Hospital
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07795424
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 33
- From 1 Sept 2026 to the primary completion date, 30 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior chemotherapy, endocrine therapy, or anti-HER2 therapy for the current breast cancer;
Other illness
- Distant metastasis (stage IV disease);
- Any other condition that, in the investigator's opinion, makes the patient unsuitable for the study.
Lab values
- Severe cardiac dysfunction or left ventricular ejection fraction (LVEF) below the institutional lower limit of normal;
Other
- Pregnancy or lactation;
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liaoning Cancer Hospital & Institute Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.