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Recruiting Phase 2

Neoadjuvant Culmerciclib Combined With Endocrine Therapy for Hormone Receptor-Positive， Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer

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About this study

This is a single-center, open-label, randomized phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant Culmerciclib combined with aromatase inhibitor versus aromatase-inhibitor monotherapy in patients with Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative early-stage breast cancer.

Condition
Hormone Receptor-Positive Breast Cancer, HER2 Low Breast Carcinoma, Early-Stage Breast Cancer
Tested
Culmerciclib, Aromatase Inhibitor (AI)
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Who can join

Age
18 to 70 years
Sex
Female only
Healthy volunteers
Not accepted

Inclusion 15

  • Minimum age: 18 years
  • Maximum age: 70 years
  • Eligible sex: Female
  • Study condition: Hormone Receptor-Positive Breast Cancer, HER2 Low Breast Carcinoma, Early-Stage Breast Cancer
  • Able to understand study procedures, voluntarily participate in the study, and provide written informed consent.
  • Female patients aged ≥18 and ≤70 years with histopathologically confirmed untreated unilateral primary invasive breast cancer.
  • Hormone-receptor positive (estrogen receptor immunohistochemical expression ≥10%), and HER2-negative (IHC 0-1+, or IHC 2+ with negative FISH test).
  • Tumor size \>2 cm or positive regional lymph nodes (TNM stage II-IIIA).
  • At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Adequate cardiac function meeting all of the following criteria:
  • i. 12-lead electrocardiogram shows no abnormality or clinically insignificant changes requiring no medical intervention; ii. QTc interval ≤480 ms; iii. No history of torsades de pointes or other symptomatic QTc abnormalities; iv. Left-ventricular ejection fraction (LVEF) ≥50%.
  • Adequate bone-marrow reserve: white blood cell count ≥3.0×10⁹/L; absolute neutrophil count ≥1.5×10⁹/L; platelet count ≥100×10⁹/L; hemoglobin ≥90 g/L.
  • Adequate hepatic and renal function: AST and ALT ≤2.5 × upper limit of normal (ULN); alkaline phosphatase ≤2.5 × ULN; total bilirubin ≤1.5 × ULN; serum creatinine ≤1.5 × ULN.
  • For pre-menopausal females or females without surgical sterilization: agree to use effective contraception during study treatment and for at least 6 months after the last dose of study treatment.

Exclusion 16

  • Occult breast cancer, inflammatory breast cancer, Paget's disease of the breast, stage IV (metastatic) breast cancer, or bilateral breast cancer.
  • Known hypersensitivity to active ingredients or other excipients of study drugs.
  • Requirement for additional anti-tumor therapy (excluding ovarian function suppression) during neoadjuvant treatment, as judged by the investigator.
  • Prior hormone-replacement therapy that has not been discontinued for at least 2 weeks before study treatment initiation.
  • Previous history of anti-tumor chemotherapy, selective estrogen-receptor modulators, or aromatase inhibitor therapy.
  • Severe cardiac diseases or conditions that would preclude tolerability of study treatment, including but not limited to:
  • Life-threatening arrhythmias or higher-grade atrioventricular block (Mobitz type II second-degree or third-degree atrioventricular block); ii.
  • Unstable angina pectoris; iii.
  • Clinically significant valvular heart disease; iv.
  • Electrocardiogram evidence of transmural myocardial infarction; v.
  • Poorly controlled hypertension.
  • Major surgery unrelated to breast cancer within 4 weeks prior to enrollment, or incomplete recovery from such surgical procedures.
  • Severe or uncontrolled infections that may interfere with study treatment or outcome assessment, including but not limited to active viral hepatitis, positive human immunodeficiency virus antibody, pulmonary infection.
  • History of other malignancies within the past 5 years (except cured carcinoma in-situ of cervix or basal-cell carcinoma of skin).
  • Underlying gastrointestinal disorders (especially chronic diarrhea or constipation), inability to swallow, intestinal obstruction, or other conditions interfering with drug intake and absorption.
  • Any other condition rendering the patient unsuitable for study participation, in the investigator's opinion

Where

1 site, 1 recruiting

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.