2023-509598-22-01RecruitingPhase 4
zAvatar test-guided therapeutic decision vs standard of care, in relapsed ovarian cancer and in metastatic breast cancer - A multicentric randomized clinical study with intervention
Source: EU CTIS (euclinicaltrials.eu) · Last updated 6 Feb 2026
Brief summary (registry, in English)
Evaluate the zAvatar-test as a predictive model of treatment efficacy to aid therapeutical decisions, in patients with relapsed ovarian cancer and in patients with metastatic breast cancer with malignant pleural effusion and/or ascites. To achieve this, we will compare: a) Progression Free Survival (PFS) of patients with relapsed ovarian cancer treated according to zAvatar-test-based therapeutic decision versus those treated according to clinical-choice (standard of care); b) Compare PFS of metastatic breast cancer patients treated according to zAvatar-test-based therapeutic decision versus those treated according to clinical-choice (standard of care).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 276 (estimated)
- First submitted
- 24 Jul 2024
- Start date
- 13 May 2025
- Lead sponsor
- Rita Fior
- Diseases
- Ovarian cancer
- EU CT number
- 2023-509598-22-01
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 276
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Ovarian cancer - Women aged ≥18 years, who are able to understand the study procedures and to provide a signed written Informed Consent Form (ICF) prior to study inclusion.
- Ovarian cancer - Measurable disease (at least one measurable lesion per RECIST 1.1 criteria or PERCIST 1.1 criteria)
- Ovarian cancer - ECOG performance status 0-2 (to enable treatment)
- Breast cancer - Women aged ≥18 years, who are able to understand the study procedures and to provide a signed written ICF prior to study inclusion.
- Breast cancer - Confirmed stage IV breast cancer (AJCC 8th edition classification), with high-volume of ascites or MPE which warrants drainage. All tumors should be HER2-negative metastatic breast cancer, independently of Estrogen Receptor (ER) status.
- Breast cancer - Patients for whom there is a decision for therapy treatment.
- Breast cancer - ECOG performance status 0-2 (to enable treatment).
- Breast cancer - Second line or following lines of treatment are accepted, however the patient should be included prior to starting a new line of treatment and should have at least 2 treatment options of therapy to be tested, according to guidelines.
- Breast cancer - Patients with adequate bone marrow and coagulation function, adequate liver, renal and cardiac functions to allow treatment.
- Breast cancer - Measurable disease (at least one measurable lesion per RECIST 1.1 criteria or PERCIST 1.1 criteria).
- Ovarian cancer - Inoperable high grade serous carcinoma (HGSC) or high grade endometrioid relapsed ovarian cancer, with high-volume of ascites or MPE, which warrants drainage: a. with platinum-sensitive disease: defined as disease progression ≥ 6 months following the last administered dose of platinum-based therapy. OR b. with platinum-resistant disease: defined as disease progression < 6 months following the last administered dose of platinum-based therapy. iii. ECOG performance status 0-2 (to enable treatment)
- Ovarian cancer - Patients for whom there is a decision for therapy treatment.
- Ovarian cancer - First line or following lines of treatment upon relapse are accepted, however the patient should be included prior to starting a new line of treatment and should have at least 2 treatment options to be tested, according to guidelines.
- Ovarian cancer - Patients with adequate bone marrow and coagulation function, adequate liver, renal and cardiac functions to allow treatment.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E. | Coimbra | Portugal | Recruiting |
| Unidade Local De Saude Lisboa Ocidental E.P.E. | Lisbon | Portugal | Recruiting |
| Unidade Local De Saude De Santa Maria E.P.E. | Lisbon | Portugal | Recruiting |
| Champalimaud Clinical Centre | Lisbon | Portugal | Recruiting |
| Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. | Lisbon | Portugal | Recruiting |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. | Porto | Portugal | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.