A Prospective, Phase II, Exploratory Study Protocol of a Chemotherapy Sensitivity-based Culmerciclib Combination Regimen in Neoadjuvant Therapy for HR+/HER2- Breast Cancer.

Sex: Female

Ages: 18 Years – 75 Years

Healthy volunteers: No

Phase: PHASE2

Enrollment: 48

Sponsor: The First Affiliated Hospital with Nanjing Medical University

Location: The First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu

Summary

To explore the efficacy and safety of Culmerciclib combined with chemotherapy as neoadjuvant therapy for HR+/HER2- breast cancer patients who are insensitive to neoadjuvant TAC (docetaxel, doxorubicin, cyclophosphamide) chemotherapy.

Eligibility Criteria

Inclusion Criteria: 1. Initially diagnosed with stage II-III breast cancer according to the AJCC 8th edition staging system. 2. Premenopausal or perimenopausal patients (who must receive ovarian function suppression \[OFS\], including bilateral oophorectomy or GnRHa \[GnRH agonists\]), or postmenopausal patients. 3. Histopathologically confirmed HR+/HER2- breast cancer: estrogen receptor (ER)-positive (\>10%), regardless of progesterone receptor (PR) expression level; HER2-negative invasive breast carcinoma as per the 2018 ASCO-CAP HER2-negative interpretation guidelines, confirmed by the pathology laboratory as immunohistochemistry (IHC) 0, 1+, or 2+ with negative in situ hybridization (ISH) (HER2/CEP17 ratio \=1.5×10⁹/L; platelet count (PLT) ≥100×10⁹/L; hemoglobin (Hb) \>=90 g/L. Blood biochemistry: total bilirubin (TBIL) =\

Source: ClinicalTrials.gov (NCT07900516). StuddyBuddy aggregates publicly available trial information.