Clinical trial in Ovarian cancer (relapsed) | Metastatic breast cancer

Inclusion criteria

• {"criterion_text":"- 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.\n- Ovarian cancer - Measurable disease (at least one measurable lesion per RECIST 1.1 criteria or PERCIST 1.1 criteria)\n- Ovarian cancer - ECOG performance status 0-2 (to enable treatment)\n- 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.\n- 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.\n- Breast cancer - Patients for whom there is a decision for therapy treatment.\n- Breast cancer - ECOG performance status 0-2 (to enable treatment).\n- 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.\n- Breast cancer - Patients with adequate bone marrow and coagulation function, adequate liver, renal and cardiac functions to allow treatment.\n- Breast cancer - Measurable disease (at least one measurable lesion per RECIST 1.1 criteria or PERCIST 1.1 criteria).\n- 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)\n- Ovarian cancer - Patients for whom there is a decision for therapy treatment.\n- 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.\n- Ovarian cancer - Patients with adequate bone marrow and coagulation function, adequate liver, renal and cardiac functions to allow treatment."}

Exclusion criteria

• {"criterion_text":"- 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.\n- Exclusion criteria for Ovarian & Breast Cancer - Patients pregnant or breastfeeding.\n- Exclusion criteria for Ovarian & Breast Cancer - Patients currently enrolled in other clinical trials, under active treatment.\n- Exclusion criteria for Ovarian & Breast Cancer - Patients that need urgent treatment (visceral crisis)."}

Primary endpoints

• {"endpoint_text":"- PFS of patients with relapsed ovarian cancer treated according to zAvatar-test-based therapeutic decision and those treated according to clinical-choice (standard of care).","definition_or_measurement_approach":"Progression-Free Survival (PFS) evaluated for relapsed ovarian cancer patients; disease measurable per RECIST 1.1 or PERCIST 1.1 (measurement approach per inclusion criteria)."}
• {"endpoint_text":"- PFS of metastatic breast cancer patients treated according to zAvatar-test-based therapeutic decision and those treated according to clinical-choice (standard of care).","definition_or_measurement_approach":"Progression-Free Survival (PFS) evaluated for metastatic breast cancer patients; disease measurable per RECIST 1.1 or PERCIST 1.1 (measurement approach per inclusion criteria)."}

Secondary endpoints

• {"endpoint_text":"- Response rate (RR) and overall survival (OS) of relapsed ovarian cancer patients treated according to zAvatar-based therapeutic decision and those treated according to clinical-choice (standard of care).","definition_or_measurement_approach":"Response rate (RR) and Overall Survival (OS) for relapsed ovarian cancer; RR likely assessed per imaging/RECIST criteria where applicable; OS measured as time to death (not otherwise detailed in source)."}
• {"endpoint_text":"- RR and OS of metastatic breast cancer patients treated according to zAvatar-based therapeutic decision and those treated according to clinical-choice (standard of care).","definition_or_measurement_approach":"Response rate (RR) and Overall Survival (OS) for metastatic breast cancer; RR likely assessed per imaging/RECIST criteria where applicable; OS measured as time to death (not otherwise detailed in source)."}
• {"endpoint_text":"- Describe HCS utilization between both treatment arms for both disease – relapsed ovarian cancer and metastatic breast cancer.","definition_or_measurement_approach":"Health Care Services (HCS) utilization measured by emergency room visits and hospitalizations as specified in secondary objectives/endpoints."}
• {"endpoint_text":"- Sequence selected multi-resistant/multi-sensitive responders/non-responders tumors, at the transcriptomic (single-cell) level (scRNAseq)","definition_or_measurement_approach":"Sequencing of selected tumors at single-cell transcriptomic level (scRNAseq) to study clonal and tumor microenvironment diversity (method specified: scRNAseq)."}

Portugal

Earliest CTIS Part Ii Submission Date

24-09-2024

Latest Decision Or Authorization Date

06-02-2026

Processing Time Days

500

Number Of Sites

11

Number Of Participants

276

Primary sponsor

Full Name

Rita Fior

Organisation Type

Health care

Country Of Registered Address

Portugal

Third parties

• {"country":"Portugal","full_name":"Evidenze Portugal Unipessoal Lda.","duties_or_roles":"codes: 1,5","organisation_type":"Pharmaceutical company"}

Co-sponsors

• Champalimaud Clinical Centre
• Rita Fior