Real World Study Using Comprehensive Genomic Data on the Next Treatment Decision Making in Metastatic Breast Cancer (HOPE)

SOLTI

Status: Active, not recruiting

Conditions: Metastatic Breast Cancer

Treatments: Other: blood sample collection and collection of tumor tissue block

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04497285

SOLTI-1903

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.