2024-513934-40-00RecruitingPhase 2
Clinical utility of a next generation sequencing-based “oncochip” for therapeutic decision in metastatic breast cancer. Study SHARP
Source: EU CTIS (euclinicaltrials.eu) · Last updated 18 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To compare progression-free-survival in the experimental group compared to standard chemotherapy
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 11 Oct 2024
- Start date
- 20 Sept 2019
- Lead sponsor
- Istituto Europeo Di Oncologia S.r.l.
- Diseases
- Metastatic breast cancer
- EU CT number
- 2024-513934-40-00
- EudraCT number
- 2017-003216-39
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 400
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with breast cancer that has spread or cannot be removed by surgery, whose disease has grown again and whose tumour has certain documented molecular changes.
- Age
- Over 18 years
- Sex
- Women only
- Disease stage
- Breast adenocarcinoma confirmed by tissue examination; inoperable locally advanced or metastatic disease, with documented progression and at least one lesion that can be measured by RECIST v1.1. Performance status 0 or 1.
- Earlier treatment
- There is no limit on earlier cancer treatments for the advanced disease. People with HER2+ disease must have had 2 or more lines of anti-HER2 treatment.
- Biomarker or test result
- Documented presence of specific molecular alterations. A tumour sample is needed: a biopsy of a metastasis or an archived sample taken no more than 6 months ago.
Main reasons for not taking part
- Known or suspected brain metastases or spinal cord compression, unless treated and stable for at least 2 weeks without corticosteroids or anti-convulsant drugs
- Clinically significant or uncontrolled heart disease
- Uncontrolled high blood pressure
- Taking part in another trial with an investigational product in the last 30 days
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- History of clinically significant or uncontrolled cardiac disease
- Uncontrolled arterial hypertension
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Europeo di Oncologia s.r.l | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.