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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06259929 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 overexpression (ER ≥ 10% by IHC) is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Does this trial require MKI67?
Yes, MKI67 overexpression (Ki67 ≥10%) is a required biomarker for enrollment.
What disease stage is eligible?
Stage CT1C or CT4B or CT4C is required.
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