OncoMatch/Clinical Trials/NCT05708235
A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population
Is NCT05708235 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Giredestrant and Abemaciclib for breast cancer.
Treatment: Giredestrant · Abemaciclib · Inavolisib — This trial is a multicenter, open-label, non-comparative, phase II, biomarker-driven adjuvant treatment study involving the periodic collection and analysis of blood samples from patients with HR-positive/HER2-negative early-stage BC at higher risk of relapse, who have undergone surgery within the previous five years, with no evidence of locoregional, contralateral, or distant disease. The study design is composed by an initial pre-screening phase, a molecular follow-up phase (ctDNA surveillance phase), and an interventional therapeutic phase (treatment phase). After informed consent is obtained, a total of 976 eligible patients will enter a ctDNA surveillance in which primary tumor tissue and matched normal blood will be collected from each patient to obtain a patient-specific somatic mutations panel (tumor signature). At the event of ctDNA positivity, patients will be screened to enter the treatment phase of the study. Upon confirmed eligibility, a total of 40 patients will be allocated in one of the following trial's arms adopting a sequential recruitment strategy: Arm A: Control Arm (N=10) Arm B: Experimental Arm with giredestrant (N=10) Arm C: Experimental Arm with giredestrant + abemaciclib (N=10) Arm D: Experimental Arm with giredestrant + inavolisib (N=10) If the strategy of ctDNA monitoring enables physicians to identify patients at high risk of relapse and assess whether treatment at molecular relapse can improve outcome, new cohorts may be added to the study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 hormone receptor-positive
HR-positive according to the updated American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2020 guidelines
Required: HER2 (ERBB2) HER2-negative
HER2-negative BC as per ASCO/CAP 2018 criteria
Required: PIK3CA mutation
Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test: Qiagen therascreen PIK3CA RGQ PCR PCR kit - CE-IVD). This determination will be done in tumor tissue.
Disease stage
Required: Stage EARLY-STAGE
Excluded: Stage IV
Patients with high-risk early-stage BC according to at least one of the following criteria: ... Absence of metastatic disease by routine clinical assessment
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy (aromatase inhibitor, tamoxifen) — adjuvant
On adjuvant treatment with ET for at least two years and no more than seven years at the time of Study enrolment with an additional three years of ET planned, and at least 6 months prior to enrolment on the same ET treatment with AI or tamoxifen (LHRH is mandatory for men and premenopausal women receiving AI, as well as for premenopausal women treated with tamoxifen, except in cases of bilateral oophorectomy.)
Cannot have received: selective estrogen receptor degrader
No prior treatment with SERDs will be allowed.
Cannot have received: phosphatidylinositol 3-kinase inhibitor
No prior treatment with any phosphatidylinositol 3-kinase (PI3K), Akt, or mammalian target of rapamycin (mTOR) inhibitors, or any agent whose mechanism of action is to inhibit the PI3K/Akt/mTOR pathway.
Cannot have received: Akt inhibitor
No prior treatment with any phosphatidylinositol 3-kinase (PI3K), Akt, or mammalian target of rapamycin (mTOR) inhibitors, or any agent whose mechanism of action is to inhibit the PI3K/Akt/mTOR pathway.
Cannot have received: mTOR inhibitor
No prior treatment with any phosphatidylinositol 3-kinase (PI3K), Akt, or mammalian target of rapamycin (mTOR) inhibitors, or any agent whose mechanism of action is to inhibit the PI3K/Akt/mTOR pathway.
Lab requirements
Blood counts
White blood cell (WBC) count > 3.0 x 10^9/L, absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelet count ≥ 100.0 x10^9/L, and hemoglobin ≥ 9.0 g/dL (≥ 5.6 mmol/L)
Kidney function
serum creatinine level ≤ 1.5 × the upper limit of normal (ULN) or an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m², as calculated using the 2021 CKD-EPI creatinine equation
Liver function
Serum albumin ≥ 3 g/dL; Bilirubin ≤ 1.5 times the upper limit of normal (ULN) (≤ 3 x ULN in the case of Gilbert's disease); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN; alkaline phosphatase (ALP) ≤ 2 × ULN.
Cardiac function
QT interval corrected through use of Fridericia's formula (QTcF) > 450 ms for women and > 470 ms for men by at least three electrocardiograms (ECGs) > 30 minutes apart; no history of idiopathic bradycardia, angina pectoris, symptomatic coronary heart disease, ventricular dysrhythmias, or risk factors for ventricular dysrhythmias such as structural heart disease, coronary heart disease, clinically significant electrolyte abnormalities, or family history of long QT syndrome within 12 months.
Adequate hematologic and organ function within 14 days before the first Study treatment on Day 1 of Cycle 1, defined by the following: Hematological (without platelet, red blood cell (RBC) transfusion, and/or granulocyte colony-stimulating factor support within 7 days before first Study treatment dose): White blood cell (WBC) count > 3.0 x 10^9/L, absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelet count ≥ 100.0 x10^9/L, and hemoglobin ≥ 9.0 g/dL (≥ 5.6 mmol/L). Hepatic: Serum albumin ≥ 3 g/dL; Bilirubin ≤ 1.5 times the upper limit of normal (ULN) (≤ 3 x ULN in the case of Gilbert's disease); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN; alkaline phosphatase (ALP) ≤ 2 × ULN. Renal: serum creatinine level ≤ 1.5 × the upper limit of normal (ULN) or an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m², as calculated using the 2021 CKD-EPI creatinine equation (National Kidney Foundation, 2021).
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