Real World Study Using Comprehensive Genomic Data on the Next Treatment Decision Making in Metastatic Breast Cancer
Real World Study Using Comprehensive Genomic Data on the Next Treatment Decision Making in Metastatic Breast Cancer
SOLTI 1903 HOPE is a national, real world clinical practice study conducted in patients
 diagnosed with metastatic breast cancer who are receiving, have just received or will receive
 treatment for its advanced disease. Patients will lead their inclusion, participation and
 follow-up in the study through a digital tool, but they are encouraged to include their
 physician's in this study. Tissue samples from metastatic (preferred) or primary tumor will
 be collected for analyses, together with blood samples. A Molecular Advisory Board (MAB) will
 assess and give recommendations according patient's molecular profile.

 The primary objective is to assess the real-world clinical practice of integration of
 molecular profiling in the Standard of Care (SoC) management of mBC patients connected
 through a digital tool.
Eligible patients are those who are 18 or older, either female or male, confirmed locally
 advanced or metastatic breast cancer of any subtype and who have received, are receiving, or
 will receive any line of treatment from metastatic disease.

 Demographic data, disease characteristics, treatment history, and quality of life data will
 be collected through a digital tool by the patient. The data are de-identified and will be
 used to advance multiple areas of research into mBC. The study will be complemented by a
 patient empowerment program that will include informative workshops and video-tutorials about
 precision medicine and the HOPE study itself. Tumor tissue samples must be submitted for
 genomic profiling using FoundationOne CDx. Blood samples for circulating tumor DNA (ctDNA)
 profiling using Guardant360 also will be collected.

 Molecular reports will be reviewed by the Molecular Advisory Board (MAB) and recommendations
 according to the molecular profile will be sent to the patients and physicians through the
 digital tool to let them know these treatment options and also notified about clinical trials
 for which they may be eligible.

 The primary objective is to assess the real-world clinical practice of integration of
 molecular profiling in the Standard of Care (SoC) management of mBC patients connected
 through a digital tool. Secondary objectives include: to describe genetic mutational profile
 from both tests, to evaluate if a patient-centric strategy could achieve better enrollment
 than the classical approach site-physician-patient, and to assess the efficacy of the program
 to allocate patients in clinical trials.
Inclusion Criteria:

 1. Female or Male patients.

 2. Age ≥18 years.

 3. Signed informed consent prior to any screening procedure.

 4. Locally advanced or metastatic breast cancer of any subtype confirmed both
 pathologically and radiologically (stage IIIb- IV disease).

 5. The subjects must be about to receive, or receiving, or will have completed treatment
 for their metastatic disease with any line of treatment in either a clinical trial or
 the healthcare setting.

 6. Availability of one metastatic (preferably), primary tumor sample or blood sample.

 7. Measurable or non-measurable disease.

 8. Quality of life score according to ECOG scale ≤ 3.

 9. Minimal life expectancy of 6 months.

 Exclusion Criteria:

 1. Inability to consent or conform to the processes involved in a clinical study.

 2. Presence of a condition or abnormality that in the opinion of the Investigator would
 compromise the safety of the patient or the quality of the data.