OncoMatch/Clinical Trials/NCT06259929
NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer
Is NCT06259929 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Abemaciclib 150 MG + Giredestrant 30 MG for breast cancer.
Treatment: Abemaciclib 150 MG + Giredestrant 30 MG — The objective of the study is to evaluate the efficacy and the safety of abemaciclib and giredestrant before surgery in participants with early stage, oestrogen receptor-positive (ER+), human epidermal receptor 2 negative (HER2-) breast cancer (BC). Primary objective: ● To evaluate the efficacy of abemaciclib and giredestrant in complete cell cycle arrest (CCCA) rate at Week 2. Secondary objectives: * To evaluate the efficacy of abemaciclib and giredestrant in reducing the relative Ki67 expression from baseline to Week 2 * To evaluate the efficacy of abemaciclib and giredestrant in risk of recurrence (ROR) score reduction, clinical and radiological tumor response; * To evaluate the safety of abemaciclib and giredestrant. Exploratory objectives: * To evaluate the mechanisms of response and resistance to therapy; * To evaluate the correlation between Ki-67% reduction and 18- Fluorothymidine (FLT) uptake reduction; * To evaluate the pathological complete response (pCR) rate (ypT0/is, ypN0) of giredestrant plus abemaciclib
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (ER ≥ 10% by IHC) (≥10% by IHC)
Confirmed ER+ disease by local testing on primary disease specimen: tumor must be ER ≥ 10% defined by immunohistochemistry (IHC) according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines for hormone receptor testing
Required: HER2 (ERBB2) negative (HER2- by ASCO/CAP 2023 guidelines)
Confirmed HER2- disease by local testing on primary disease specimen: tumor must be HER2- according to ASCO/CAP 2023 guidelines for HER2 testing
Required: MKI67 overexpression (Ki67 ≥10%) (Ki67 ≥10%)
Ki67 score ≥10% analyzed locally and centrally confirmed
Disease stage
Required: Stage CT1C, CT4B, CT4C (AJCC TNM)
Patients with cT1c (≥1.0 cm)-cT4a-c BC at presentation; a-c primary tumor must be ≥ 1.0 cm in longest diameter by ultrasound
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
No previous treatment of the disease by chemotherapy
Cannot have received: hormone therapy (aromatase inhibitors, tamoxifen, selective estrogen receptor down regulator)
No previous treatment of the disease by hormone therapy; history of any prior treatment with aromatase inhibitors (AIs), tamoxifen, selective estrogen receptor down regulator
Cannot have received: cyclin-dependent kinase 4 and 6 inhibitor
history of any prior treatment with...cyclin-dependent kinase 4 and 6 inhibitors
Cannot have received: surgery
No previous treatment of the disease by...surgery
Cannot have received: radiotherapy
No previous treatment of the disease by...radiotherapy
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; Platelets count ≥100x 10^9/L; Haemoglobin ≥9 g/dL (90 g/L)
Kidney function
Serum creatinine≤1.5 x ULN or estimated creatinine clearance≥60 ml/min
Liver function
Total serum bilirubin ≤1.5 x ULN (Gilbert's syndrome ≤2.0 x ULN and direct bilirubin within normal limits allowed); AST and/or ALT ≤3 x ULN; Alkaline phosphatase ≤2.5 x ULN
Cardiac function
QTcF ≤470 ms for women; no history of NYHA Class III/IV CHF, significant arrhythmias, or other significant cardiac disease
Adequate bone marrow and coagulation and adequate organ function defined as follows: ANC ≥ 1.5 x 10^9/L; Platelets count ≥100x 10^9/L; Haemoglobin ≥9 g/dL (90 g/L); Serum creatinine≤1.5 x ULN or estimated creatinine clearance≥60 ml/min; Total serum bilirubin ≤1.5 x ULN (Gilbert's syndrome ≤2.0 x ULN and direct bilirubin within normal limits allowed); AST and/or ALT ≤3 x ULN; Alkaline phosphatase ≤2.5 x ULN; cardiac exclusion criteria as listed
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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