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 (Sep 2026). This Phase 2 trial studies multiple treatments including Giredestrant and Abemaciclib for breast cancer.
Treatment: Giredestrant · Abemaciclib · Inavolisib · Standard ET followed by change in treatment — 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
Treatments studied
Targeted therapy
Endocrine / hormonal
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (positive)
HR-positive according to the updated ASCO/CAP 2020 guidelines
Required: HER2 (ERBB2) wild-type (absence)
HER2-negative BC as per ASCO/CAP 2018 criteria
Required: PIK3CA mutation
Central confirmation of biomarker eligibility (detection of specified PIK3CA mutation(s) via Qiagen therascreen® PIK3CA RGQ PCR kit [CE-IVD]) in tumor tissue sample.
Performance status
ECOG 0–1(Restricted strenuous activity)
ECOG performance status 0 or 1
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 six months prior to enrolment on the same ET treatment with AI or tamoxifen (LHRH agonist is mandatory for male and premenopausal participants receiving AI or tamoxifen, except in cases of bilateral oophorectomy).
Cannot have received: selective estrogen receptor degrader
No prior treatment with selective estrogen receptor degraders (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
WBC > 3.0 x 10^9/L, ANC ≥ 1.5 x 10^9/L, platelet count ≥ 100.0 x10^9/L, hemoglobin ≥ 9.0 g/dL (≥ 5.6 mmol/L)
Kidney function
serum creatinine level ≤ 1.5x ULN or eGFR ≥ 30 mL/min/1.73 m² (CKD-EPI 2021 equation)
Liver function
Serum albumin ≥ 3 g/dL; Bilirubin ≤ 1.5x ULN (≤ 3x ULN in the case of Gilbert's disease); AST and ALT ≤ 2.5x ULN; ALP ≤ 2 × ULN.
Cardiac function
QTcF ≤ 450 ms for women and ≤ 470 ms for men by at least three ECGs > 30 minutes apart; no history of idiopathic bradycardia, angina pectoris, symptomatic coronary heart disease, ventricular dysrhythmias, or risk factors for ventricular dysrhythmias; no clinically significant electrolyte abnormalities
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, RBC transfusion, and/or G-CSF support within seven days before first Study treatment dose): WBC > 3.0 x 10^9/L, 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 ≤ 1.5x ULN (≤ 3x ULN in the case of Gilbert's disease); AST and ALT ≤ 2.5x ULN; ALP ≤ 2 × ULN. Renal: serum creatinine level ≤ 1.5x ULN or eGFR ≥ 30 mL/min/1.73 m² (CKD-EPI 2021 equation). Cardiac: QTcF ≤ 450 ms for women and ≤ 470 ms for men by at least three ECGs > 30 minutes apart; no history of idiopathic bradycardia, angina pectoris, symptomatic coronary heart disease, ventricular dysrhythmias, or risk factors for ventricular dysrhythmias; no clinically significant electrolyte abnormalities.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05708235 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior selective estrogen receptor degrader, phosphatidylinositol 3-kinase inhibitor, Akt inhibitor disqualifies patients from enrollment.
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.
Does this trial require PIK3CA?
Yes, PIK3CA mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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