A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjent musi wyrazić zgodę na udział w badaniu.
- •Wiek 18 lat lub więcej.
- •Rak piersi (typ HR-dodatni, HER2-ujemny) zdiagnozowany w przeszłości i leczony operacyjnie w ciągu ostatnich pięciu lat.
- •Rak piersi we wczesnym stadium, uznany za mający wysokie ryzyko nawrotu.
- •Pacjent musi znajdować się w dobrym ogólnym stanie zdrowia (sprawność 0 lub 1 według skali ECOG).
- •Pacjent musi być w trakcie leczenia hormonalnego (ET) od co najmniej dwóch lat.
✗ Disqualifies
- •Obecność choroby nowotworowej w innych miejscach organizmu (przerzuty odległe) lub nawrót miejscowy/przerzuty do drugiego sutka.
- •Niedawne lub trwające inne leczenie przeciwnowotworowe, które mogłoby wpłynąć na wyniki badania.
- •Niektóre istniejące choroby współistniejące, które mogą stanowić ryzyko dla pacjenta podczas badania.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- March 5, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (41)
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, Spain
Hospital General Universitario Dr. Balmis
Alicante, Spain
Hospital Marina Salud de Denia
Alicante, Spain
Hospital Virgen de los Lirios
Alicante, Spain
Fundació Althaia
Barcelona, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain
Hospital Universitari Dexeus
Barcelona, Spain
Hospital Universitario de Basurto
Bilbao, Spain
Hospital Provincial de Castellón
Castellon, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital del Vinalopó
Elche, Spain
Institut Català d' Oncologia Girona (ICO)
Girona, Spain
Hospital Universitario Clínico San Cecilio de Granada
Granada, Spain
Complejo Hospitalario de Jaén
Jaén, Spain
Hospital Universitario de León
León, Spain
Hospital Universitario Arnau de Vilanova de Lleida
Lleida, Spain
Clínica Universidad de Navarra
Madrid, Spain
Hospital Beata María Ana
Madrid, Spain
Hospital Universitario de Torrejón
Madrid, Spain
Hospital Universitario Doce de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Sanchinarro-START-CIOCC
Madrid, Spain
Hospital Regional Universitario de Málaga (Hospital Carlos Haya)
Málaga, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain
Hospitalario Universitario de Navarra
Pamplona, Spain
Hospital de Sagunto
Sagunto, Spain
Hospital Quirónsalud Sagrado Corazón
Seville, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Universitari Sant Joan de Reus
Tarragona, Spain
Hospital Arnau de Vilanova de Valencia
Valencia, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Spain
Hospital Universitario La Ribera, Alzira
Valencia, Spain
Complejo Hospitalario Universitario de Vigo
Vigo, Spain
Hospital de Xativa
Xàtiva, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
University Hospital Coventry
Coventry, United Kingdom
Royal Surrey County Hospital NHS Foundation Trust
Guildford, United Kingdom
Barts Cancer Institute
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Trial contact
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.