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
Key facts
- Where
- Coimbra, Lisbon és Porto, PortugáliaSee the 6 sites
- Phase
- 4. fázis
Where in Portugália
- Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.Coimbra, PortugáliaTaking people
- Champalimaud Clinical CentreLisbon, PortugáliaTaking people
- Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.Lisbon, PortugáliaTaking people
- Unidade Local De Saude De Santa Maria E.P.E.Lisbon, PortugáliaTaking people
- Unidade Local De Saude Lisboa Ocidental E.P.E.Lisbon, PortugáliaTaking people
- Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.Porto, PortugáliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Rita Fior
- Trial code
- EU 2023-509598-22-01
- Record updated
- 2026. február 6.
- Original description
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).Read full original descriptionShow less
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).
Inclusion: 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.