zAvatar test to guide treatment in relapsed ovarian cancer and metastatic breast cancer
Tests a lab-based test guiding treatment choice in relapsed ovarian and metastatic breast cancer.
Key facts
- Who runs it
- Rita Fior
- Where
- Coimbra, Lisbon, and Porto, PortugalSee the 6 sites
- Trial code
- EU 2023-509598-22-01
- U1111-1308-0481
- Registry title
- 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
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 276 people, planned
- Started
- 13 May 2025
- Expected to end
- 31 Dec 2031
- Type of study
- Interventional
- Record updated
- 6 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with ovarian cancer that has come back, or with stage IV breast cancer with fluid build-up that needs draining. It tests a lab test (zAvatar) to guide treatment choice.
- Age
- 18 years or older.
- Sex
- Women only.
- Disease stage
- Ovarian cancer: inoperable high grade serous or high grade endometrioid cancer that has relapsed, with a large amount of fluid in the belly or around the lungs that needs draining. Breast cancer: confirmed stage IV, HER2-negative, with a large amount of fluid in the belly or around the lungs that needs draining. All need measurable disease and ECOG performance status 0-2.
- Earlier treatment
- First or later lines of treatment are accepted. People must join before starting a new line of treatment. At least 2 treatment options must be available to test, according to guidelines. For ovarian cancer, both platinum-sensitive and platinum-resistant disease can join.
- Biomarker or test result
- Breast cancer must be HER2-negative, whatever the Estrogen Receptor (ER) status.
Main reasons for not taking part
- Pregnant or breastfeeding
- Currently in another clinical trial with active treatment
- Needs urgent treatment (visceral crisis)
- Health conditions that could make taking part or following the study steps difficult, in the study doctor's opinion
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Where in Portugal
- Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.Coimbra, PortugalTaking people
- Champalimaud Clinical CentreLisbon, PortugalTaking people
- Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.Lisbon, PortugalTaking people
- Unidade Local De Saude De Santa Maria E.P.E.Lisbon, PortugalTaking people
- Unidade Local De Saude Lisboa Ocidental E.P.E.Lisbon, PortugalTaking people
- Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.Porto, PortugalTaking people
About the trial
What the trial wants to find out
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).
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- zAvatar test to guide treatment in relapsed ovarian cancer and metastatic breast cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 6 February 2026