Clinical utility of a next generation sequencing-based oncochip” for therapeutic decision in metastatic breast cancer. Study SHARP
- Conditions
- Metastatic breast cancerMedDRA version: 20.0Level: LLTClassification code 10006285Term: Breast neoplasm NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-003216-39-IT
- Lead Sponsor
- ISTITUTO EUROPEO DI ONCOLOGIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 400
Screening
1.Provision of signed, written and dated informed consent for genetic research.
2.Patients with histologically confirmed breast adenocarcinoma.
3.Patient has radiologic evidence of inoperable locally advanced, or metastatic BC
4.Presence of an accessible metastatic lesion for biopsy or at least one archived metastatic tumour sample collected no longer than 6 months earlier.
5.Presence of measurable target lesion according to RECIST criteria v1.1.
6.Age > 18 years and <75 years.
7.PS 0/1
8.Patient must have received a minimum of 1 line of chemotherapy and\or endocrine therapies in the metastatic setting. Patients with HER2+ disease must have received 3 or more line of antiHER2 treatment (including dual blockade with pertuzumab/trastuzumab if reimbursed, TDM1 and lapatinib).
9.Life expectancy =3 months.
10.For women with childbearing potential, a negative pregnancy test within 14 days prior to initiation of the study drug.
11.Ability to swallow oral capsules
12.Normal echocardiogram at baseline (left ventricular ejection fraction [LVEF] >50% and shortening fraction [SF] >15%).
PATIENT RANDOMIZATION IN THE THERAPEUTIC PHASE
1) Patients who still meet the screening phase inclusion criteria
2) Patients will have had a minimum of 21 days gap from last chemotherapy or biological therapy administration prior to therapy modification.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
1. 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.
2. History of clinically significant or uncontrolled cardiac disease, including angina, coronary artery bypass graft, angioplasty, vascular stent , myocardial infarction, atrial fibrillation within 6 months or history of ventricular arrhythmia, Congestive Cardiac Failure (CCF) or Ischaemic Heart Disease (IHD) with no limit of time (New York Heart Association [NYHA] functional classification = 3. Uncontrolled arterial hypertension (defined as systolic blood pressure = 140mmHg and/or diastolic blood pressure = 90mmHg with optimized antihypertensive therapy or patient treated with more than 2 antihypertensive agents) or systolic blood pressure = 160mmHg and/or diastolic blood pressure = 100mmHg :
4. Participation in another clinical study with an investigational product (IP) during the last 30 days.
5. Bone metastases as the only site of biopsiable disease
6. Previous treatment with the study drugs or drugs of this class (e.g. Everolimus)
PATIENT RANDOMIZATION IN THE THERAPEUTIC PHASE
1) Patients who still meet the screening phase exclusion criteria
2) Residual toxicities of grade > 2 from previous treatments, with the exception of alopecia.
3) Major surgery within 30 days prior to entry into the study (excluding placement of vascular access or minor surgery within 14 days of entry into the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method