Clinical utility of a next generation sequencing-based oncochip” for therapeutic decision in metastatic breast cancer. Study SHARP - SHARP

ISTITUTO EUROPEO DI ONCOLOGIA0 sites400 target enrollmentOctober 18, 2021

DrugsCASODEX - 50 MG COMPRESSE RIVESTITE CON FILM 28 COMPRESSE LYNPARZA

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA
Enrollment: 400
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 18, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

ISTITUTO EUROPEO DI ONCOLOGIA

Eligibility Criteria

Inclusion Criteria

•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.
•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

Exclusion Criteria

•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.