OncoMatch/Clinical Trials/NCT07796880
Neoadjuvant Culmerciclib Combined With Endocrine Therapy for Hormone Receptor-Positive， Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer
Official title: Neoadjuvant Culmerciclib Combined With Endocrine Therapy Versus Endocrine Therapy Alone for Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Breast Cancer: a Single-center, Open-label, Randomized-controlled Phase II Clinical Trial
Is NCT07796880 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Culmerciclib and Aromatase Inhibitor (AI) for hormone receptor-positive breast cancer.
Treatment: Culmerciclib · Aromatase Inhibitor (AI) — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (immunohistochemical expression ≥10%)
Hormone-receptor positive (estrogen receptor immunohistochemical expression ≥10%)
Required: HER2 (ERBB2) wild-type (IHC 0-1+, or IHC 2+ with negative FISH test)
HER2-negative (IHC 0-1+, or IHC 2+ with negative FISH test)
Disease stage
Required: Stage II, IIIA
Excluded: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: anti-tumor chemotherapy
Previous history of anti-tumor chemotherapy
Cannot have received: selective estrogen-receptor modulator
Previous history of selective estrogen-receptor modulators
Cannot have received: aromatase inhibitor
Previous history of aromatase inhibitor therapy
Lab requirements
Blood counts
white blood cell count ≥3.0×10⁹/L; absolute neutrophil count ≥1.5×10⁹/L; platelet count ≥100×10⁹/L; hemoglobin ≥90 g/L
Kidney function
serum creatinine ≤1.5 × ULN
Liver function
AST and ALT ≤2.5 × ULN; alkaline phosphatase ≤2.5 × ULN; total bilirubin ≤1.5 × ULN
Cardiac function
12-lead ECG shows no abnormality or clinically insignificant changes; QTc interval ≤480 ms; no history of torsades de pointes or other symptomatic QTc abnormalities; LVEF ≥50%
Adequate cardiac function...; Adequate bone-marrow reserve...; Adequate hepatic and renal function...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07796880 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or IIIA is required.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages