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Clinical utility of a next generation sequencing-based “oncochip” for therapeutic decision in metastatic breast cancer. Study SHARP
EU CTIS ID: 2024-513934-40-00
What this study is testing
To compare progression-free-survival in the experimental group compared to standard chemotherapy
- Therapeutic exploratory (Phase II)
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
- 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.
You likely can't join if
- 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.
- History of clinically significant or uncontrolled cardiac disease
- Uncontrolled arterial hypertension
- Participation in another clinical study with an investigational product (IP) during the last 30 days
See the full eligibility criteria
- 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).
- 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.
- History of clinically significant or uncontrolled cardiac disease
- Uncontrolled arterial hypertension
- Participation in another clinical study with an investigational product (IP) during the last 30 days
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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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.