Clinical utility of a next generation sequencing-based “oncochip” for therapeutic decision in metastatic breast cancer. Study SHARP
Key facts
- Where
- Milan, OlaszországSee the site
- Phase
- 2. fázis
Where in Olaszország
- Istituto Europeo di Oncologia s.r.lMilan, OlaszországTaking 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
- Istituto Europeo Di Oncologia S.r.l.
- Trial code
- EU 2024-513934-40-00
- Record updated
- 2024. november 18.
- Original description
To compare progression-free-survival in the experimental group compared to standard chemotherapyRead full original descriptionShow less
To compare progression-free-survival in the experimental group compared to standard chemotherapy
Inclusion: Signed informed consent form; Life expectancy =3 months; For women with childbearing potential, a negative pregnancy test within 14 days prior to initiation of the study drug; Ability to swallow oral capsules; Ecocardiogramma normale al baseline ( LVEF >50% e SF >15%); Patients with histologically confirmed breast adenocarcinoma; Patients with documented presence of specific molecular alterations; Patient has radiologic evidence of inoperable locally advanced, or metastatic BC; 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; 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; Age > 18 years; PS 0/1; 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: 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; Participation in another clinical study with an investigational product (IP) during the last 30 days; History of clinically significant or uncontrolled cardiac disease; Uncontrolled arterial hypertension.