Active, not recruitingPhase IIEN originalBreast cancerHormone receptor positive (HR+)Early / localized

A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

This trial is no longer recruiting — here are similar active trials

Matched by cancer type/biomarker, currently recruiting.

RecruitingUnknown phase🇵🇱 PolandFemale onlyBreast cancerMetastatic / advanced

The overall aim of this project is to help improve the Health Related Quality of Life (HRQOL) of metastatic breast cancer (MBC) patients. There is currently an urgent and unmet need for specific tools to aid in the evaluation of HRQOL in MBC and this project aims to address these needs by developing a comprehensive EORTC questionnaire for assessing the HRQOL of this group. The new module will be used in conjunction with EORTC QLQ-C30 and will provide better measurement of the quality of life issues experienced by women with MBC. Interviews will be conducted with patients from several centres across Europe, guiding the development process in a patient centred way.

This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy. Enrollment for the main study is now complete.

RecruitingPhase III🇵🇱 PolandLung cancerEarly / localized

The main purpose of this study is to evaluate the efficacy of divarasib compared with investigator's choice of immunotherapy (pembrolizumab or nivolumab) or observation in participants with resected Kirsten rat sarcoma viral oncogene homolog glycine 12 to cysteine (KRAS G12C)-positive Stage II-IIIB NSCLC, regardless of tumor programmed death-ligand 1 (PD-L1) status, who have not achieved pathologic complete response (pCR) following neoadjuvant chemoimmunotherapy.

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)
September 24, 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

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Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.

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