SELUMETINIB for Metastatic breast cancer

Inclusion criteria

• {"criterion_text":"- Signed informed consent form.\n- Life expectancy =3 months\n- For women with childbearing potential, a negative pregnancy test within 14 days prior to initiation of the study drug.\n- Ability to swallow oral capsules\n- Ecocardiogramma normale al baseline ( LVEF >50% e SF >15%)\n- Patients with histologically confirmed breast adenocarcinoma.\n- Patients with documented presence of specific molecular alterations.\n- Patient has radiologic evidence of inoperable locally advanced, or metastatic BC\n- Presence of measurable lesions according to RECIST criteria v1.1. Lytic bone lesions or mixed lytic-blastic lesions , that can be evaluated by MRI , can be considered as measurable lesions.\n- Presence of an accessible metastatic lesion for biopsy or at least one archived metastatic tumour sample collected no longer than 6 months earlier. For patients with only bone lesions the biopsy is not mandatory but an available tumor sample (including primitive tumor) is requested\n- Age > 18 years\n- PS 0/1\n- Patients should have documented disease progression. There are not limits to previous systemic anticancer therapy for the metastatic or locally recurrent disease. Patients with HER2+ disease must have received 2 or more line of antiHER2 treatment (including dual blockade with pertuzumab/trastuzumab and T-DM1 or other anti HER2 agents that my impact OS)."}

Exclusion criteria

• {"criterion_text":"- Patients with known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, has been treated with surgery and / or radiation, and has been stable without requiring corticosteroids nor anti-convulsant medications for at least 2 weeks prior to the first dose of study medication.\n- History of clinically significant or uncontrolled cardiac disease\n- Uncontrolled arterial hypertension\n- Participation in another clinical study with an investigational product (IP) during the last 30 days"}

Primary endpoints

• {"endpoint_text":"- progression free-survival","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":""}

Italy

Earliest CTIS Part Ii Submission Date

19-04-2024

Latest Decision Or Authorization Date

18-11-2024

Processing Time Days

213

Number Of Sites

1

Number Of Participants

400

Primary sponsor

Full Name

Istituto Europeo Di Oncologia S.r.l.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"","full_name":"Ministero della Salute","duties_or_roles":"Source of monetary support / funder","organisation_type":""}
• {"country":"","full_name":"Fondazione AIRC per la Ricerca sul Cancro","duties_or_roles":"Source of monetary support / funder","organisation_type":""}