OncoMatch/Clinical Trials/NCT07492394
Dalpiciclib With or Without Entinostat and Letrozole in HR+/HER2- Early Breast Cancer
Is NCT07492394 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including entinostat and Dalpiciclib for breast cancer.
Treatment: entinostat · Dalpiciclib · Letrozole — Brief Summary This is an open-label, randomized, phase II clinical study designed to evaluate neoadjuvant treatment regimens in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer. A total of 60 premenopausal, perimenopausal, and postmenopausal patients with HR+/HER2- breast cancer who meet the inclusion criteria will be enrolled. During the study, clinical information will be collected according to standard practice, including demographic data, tumor imaging, and pathological results (e.g., Ki-67). Investigator-assessed outcomes will be used as the final results. After 14 days of treatment, patients who provide consent will undergo a second biopsy to evaluate the rate of complete cell-cycle arrest. Safety assessments and imaging evaluations will be performed at treatment completion or upon study withdrawal. Informed consent must be obtained at each study center before participation. Treatment arms: Arm A (30 patients): Dalpiciclib 125 mg orally once daily on Days 1-21 of each 28-day cycle (3 weeks on, 1 week off), for 6 cycles Letrozole 2.5 mg orally once daily continuously for 6 cycles Entinostat 3 mg orally once weekly (Days 1-28 of each 28-day cycle), for 6 cycles Arm B (30 patients): Dalpiciclib 150 mg orally once daily on Days 1-21 of each 28-day cycle, for 6 cycles Letrozole 2.5 mg orally once daily continuously for 6 cycles Premenopausal and perimenopausal women will also receive ovarian function suppression (OFS), such as with a GnRHa agent. After signing informed consent, patients will begin neoadjuvant therapy with dalpiciclib plus entinostat and letrozole ± OFS. Ultrasound assessments will be conducted every two treatment cycles and before surgery under the same imaging conditions as baseline. Bone scans will be performed at the end of neoadjuvant treatment. MRI of the breast will be performed at baseline, after two cycles, and before surgery to assess treatment efficacy. Treatment discontinuation will occur if toxicity is intolerable, consent is withdrawn, or the investigator determines it is necessary. Adjuvant therapy: After surgery, patients will receive physician's choice of therapy (TPC). Safety follow-up: Patients will be followed until they start another anticancer therapy, all adverse events have resolved to Grade 0-1 or baseline level, or death-whichever occurs first.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (>10%)
estrogen receptor (ER)-positive (>10%)
Required: HER2 (ERBB2) negative (IHC 0+ or IHC 2+ with ISH-negative, amplification ratio <2.0)
HER2-negative according to the 2018 ASCO/CAP HER2 testing guidelines (IHC 0+ or IHC 2+ with ISH-negative, amplification ratio <2.0)
Disease stage
Required: Stage T1C-T2, CN1-2, T3-T4, CN0-2
Excluded: Stage IV
clinical stage T1c-T2, cN1-2, or T3-T4, cN0-2. Stage IV (metastatic) breast cancer at initial diagnosis [excluded].
Prior therapy
Cannot have received: chemotherapy
Exception: except diagnostic biopsy for primary breast cancer
No prior anticancer therapy for breast cancer, including chemotherapy, endocrine therapy, or targeted therapy. Prior chemotherapy, endocrine therapy, or biologic therapy for breast cancer (except diagnostic biopsy for primary breast cancer) [excluded].
Cannot have received: endocrine therapy
Exception: except diagnostic biopsy for primary breast cancer
No prior anticancer therapy for breast cancer, including chemotherapy, endocrine therapy, or targeted therapy. Prior chemotherapy, endocrine therapy, or biologic therapy for breast cancer (except diagnostic biopsy for primary breast cancer) [excluded].
Cannot have received: targeted therapy
Exception: except diagnostic biopsy for primary breast cancer
No prior anticancer therapy for breast cancer, including chemotherapy, endocrine therapy, or targeted therapy. Prior chemotherapy, endocrine therapy, or biologic therapy for breast cancer (except diagnostic biopsy for primary breast cancer) [excluded].
Lab requirements
Blood counts
ANC ≥1.5 × 10⁹/L; WBC ≥3.0 × 10⁹/L; Platelet count ≥90 × 10⁹/L; Hemoglobin ≥90 g/L
Kidney function
BUN and creatinine ≤1.5 × ULN, with creatinine clearance ≥60 mL/min (Cockcroft-Gault formula)
Liver function
Total bilirubin (TBIL) ≤ upper limit of normal (ULN); ALT and AST ≤1.5 × ULN; significant liver disease such as acute or fulminant hepatitis, impaired coagulation factor synthesis, or other severe hepatic dysfunction [excluded]
Cardiac function
Baseline left ventricular ejection fraction (LVEF) ≥50%; Corrected QT interval ≤470 ms (12-lead ECG); history of congestive heart failure, unstable angina, significant arrhythmia, or myocardial infarction [excluded]
Adequate organ function: Hematology (within 1 week): ANC ≥1.5 × 10⁹/L, WBC ≥3.0 × 10⁹/L, Platelet count ≥90 × 10⁹/L, Hemoglobin ≥90 g/L; Liver and kidney function (within 1 week): TBIL ≤ ULN, ALT and AST ≤1.5 × ULN, BUN and creatinine ≤1.5 × ULN, with creatinine clearance ≥60 mL/min (Cockcroft-Gault formula); ECG: Corrected QT interval ≤470 ms (12-lead ECG); Baseline LVEF ≥50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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