A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population
Recruiting now · Phase 2
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT05708235
- Run by
- MedSIR
- People needed
- 976
- Starts
- 2024-04-01
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2026-03-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Complejo Hospitalario Universitario A Coruña (CHUAC) — A Coruña, Spain (enrolling)
- Hospital General Universitario Dr. Balmis — Alicante, Spain (enrolling)
- Hospital Marina Salud de Denia — Alicante, Spain (enrolling)
- Hospital Virgen de los Lirios — Alicante, Spain (enrolling)
- Fundació Althaia — Barcelona, Spain (enrolling)
- Hospital Clínic i Provincial de Barcelona — Barcelona, Spain (enrolling)
- Hospital Universitari Dexeus — Barcelona, Spain (enrolling)
- Hospital Universitario de Basurto — Bilbao, Spain (enrolling)
- Hospital Provincial de Castellón — Castellon, Spain (enrolling)
- Hospital Universitario Reina Sofía — Córdoba, Spain (enrolling)
- Hospital del Vinalopó — Elche, Spain (enrolling)
- Institut Català d' Oncologia Girona (ICO) — Girona, Spain (enrolling)
- Hospital Universitario Clínico San Cecilio de Granada — Granada, Spain (enrolling)
- Complejo Hospitalario de Jaén — Jaén, Spain (enrolling)
- Hospital Universitario de León — León, Spain (enrolling)
- Hospital Universitario Arnau de Vilanova de Lleida — Lleida, Spain (enrolling)
- Clínica Universidad de Navarra — Madrid, Spain (enrolling)
- Hospital Beata María Ana — Madrid, Spain (enrolling)
- Hospital Universitario de Torrejón — Madrid, Spain (enrolling)
- Hospital Universitario Doce de Octubre — Madrid, Spain (enrolling)
- Hospital Universitario La Paz — Madrid, Spain (enrolling)
- Hospital Universitario Sanchinarro-START-CIOCC — Madrid, Spain (enrolling)
- Hospital Regional Universitario de Málaga (Hospital Carlos Haya) — Málaga, Spain (enrolling)
- Hospital Universitario Virgen de la Victoria — Málaga, Spain (enrolling)
- Hospital Clínico Universitario Virgen de la Arrixaca — Murcia, Spain (enrolling)
Full record on ClinicalTrials.gov
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