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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
EU CTIS ID: 2023-509598-22-01
What this study is testing
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).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Exclusion criteria for Ovarian & Breast Cancer - Patients with clinical conditions that, in the physician co-investigator opinion, could compromise the participation in the study and compliance with study procedures.
- Exclusion criteria for Ovarian & Breast Cancer - Patients pregnant or breastfeeding.
- Exclusion criteria for Ovarian & Breast Cancer - Patients currently enrolled in other clinical trials, under active treatment.
- Exclusion criteria for Ovarian & Breast Cancer - Patients that need urgent treatment (visceral crisis).
See the full eligibility criteria
- 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.
- Exclusion criteria for Ovarian & Breast Cancer - Patients with clinical conditions that, in the physician co-investigator opinion, could compromise the participation in the study and compliance with study procedures.
- Exclusion criteria for Ovarian & Breast Cancer - Patients pregnant or breastfeeding.
- Exclusion criteria for Ovarian & Breast Cancer - Patients currently enrolled in other clinical trials, under active treatment.
- Exclusion criteria for Ovarian & Breast Cancer - Patients that need urgent treatment (visceral crisis).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.