Culmerciclib plus aromatase inhibitors for early ER-positive/HER2-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase II, prospective trial using a response-adapted neoadjuvant approach in early breast cancer. All eligible patients receive initial treatment with culmerciclib plus an aromatase inhibitor, followed by on-treatment response assessment. Patients with an adequate response continue the same regimen; those with a suboptimal response switch to alternative strategies before surgery. The goal is to tailor neoadjuvant therapy to early tumor response, potentially improving efficacy and reducing exposure to ineffective treatments. The study uses an adaptive algorithm to guide subsequent management within a defined protocol framework.

Why it matters

Who can join: the full rules

Inclusion Criteria Female patients aged ≥18 and ≤75 years. Histologically confirmed estrogen receptor (ER)-positive (≥10%) and HER2-negative breast cancer, according to the 2018 ASCO/CAP guidelines. HER2-negative status is defined as immunohistochemistry (IHC) 0 or 1+, or IHC 2+ with negative in situ hybridization (ISH) (ISH ratio \<2.0), as confirmed by a certified pathology laboratory.

Ki-67 ≥20% assessed on core needle biopsy samples. Newly diagnosed, treatment-naïve patients with stage I-IIIA disease according to the AJCC 8th edition.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Adequate bone marrow function:

1. Absolute neutrophil count ≥1.5 × 10⁹/L (without growth factor support within 14 days);
2. Platelet count ≥100 × 10⁹/L (without transfusion or supportive therapy within 7 days);
3. Hemoglobin ≥100 g/L (without transfusion within 7 days).

Adequate hepatic and renal function:

1. Total bilirubin ≤1 × upper limit of normal (ULN);
2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN (≤5 × ULN in patients with liver metastases);
3. Blood urea nitrogen and serum creatinine ≤1.5 × ULN, and creatinine clearance ≥50 mL/min (calculated using the Cockcroft-Gault formula).

Left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiography. QT interval ≤480 ms on 12-lead electrocardiogram (ECG). Ability and willingness to undergo tumor biopsy. Provision of written informed consent. Exclusion Criteria Prior receipt of any anticancer therapy, including chemotherapy, radiotherapy, targeted therapy, or endocrine therapy.

Concurrent treatment with other anticancer agents. Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer. Stage IV breast cancer. Breast cancer not confirmed by histopathology. History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix.

Severe dysfunction of major organs, including heart, liver, or kidneys. Conditions affecting oral drug administration or absorption, including inability to swallow, chronic diarrhea, or intestinal obstruction.

Participation in another interventional clinical trial within 4 weeks prior to enrollment.

Known hypersensitivity to any component of the study drugs; history of immunodeficiency, including HIV infection, active hepatitis B or C infection, other acquired or congenital immunodeficiency disorders, or history of organ transplantation.

History of significant cardiovascular disease, including but not limited to clinically significant arrhythmias requiring treatment, myocardial infarction, heart failure, or any other cardiac condition deemed unsuitable by the investigator.

Pregnant or breastfeeding women; women of childbearing potential with a positive pregnancy test at baseline, or unwilling to use effective contraception during the study period.

Any serious concomitant disease that, in the investigator's judgment, may compromise patient safety or compliance with the study, including but not limited to uncontrolled hypertension, severe diabetes, or active infection.

History of neurological or psychiatric disorders, including epilepsy or dementia.

Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in the study.

Where it's running

• 2nd Affiliated Hospital, School of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Yiding Chen — Second Affiliated Hospital, Zhejiang University, School of Medicine
• Study coordinator: Yunxiang Zhou
• Email: yxzhou@zju.edu.cn
• Phone: 15868131018

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.