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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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HOPE: Real World Clinical Practice Study to Assess the Impact of Using Comprehensive Genomic Data on the Next Treatment Decision Making Choice in Patients With Locally Advanced or Metastatic Breast Cancer in Spain

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Other: blood sample collection and collection of tumor tissue block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or Male patients. Age ≥18 years. Signed informed consent prior to any screening procedure. Locally advanced or metastatic breast cancer of any subtype confirmed both pathologically and radiologically (stage IIIb- IV disease). 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. Availability of one metastatic (preferably), primary tumor sample or blood sample. Measurable or non-measurable disease. Quality of life score according to ECOG scale ≤ 3. Minimal life expectancy of 6 months. Exclusion Criteria: Inability to consent or conform to the processes involved in a clinical study. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: blood sample collection and collection of tumor tissue block|blood sample collection and collection of tumor tissue block|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metastatic breast cancer management based on tumor molecular profile | The number of patients assigned to different treatments based on the genomic profile. | 1 year after end of accrual | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the genetic mutational profile in tumor tissue. | To describe the genetic mutational profile of the patients using Foundation One CDx. | Ongoing basis during 3 years' patient recruitment | 
| Description of the genetic mutational profile in blood samples | To describe the genetic mutational profile of the patients using liquid biopsy (Guardant360 test). | Ongoing basis during 3 years' patient recruitment | 
| Description of the enrollment rate of the study | To describe the enrollment rate using the HOPE patient centric strategy (videotutorials and user experience of different technologies as the digital tool). | Ongoing basis during 3 years' patient recruitment | 
| Feasibility of implementing the program for metastatic breast cancer | To describe number of patients who are allocated to clinical trials and number of patients allocated on on-label therapies considering tumor genomic profile. | 1 year after end of accrual and subsequently during follow up period of 5 years | 
| Correlation between efficacy endpoints among patients enrolled in clinical trials according to the tumor's genomic profile and among patients receiving SoC. | To describe of PFS and OS among the patients enrolled in clinical trials according to the tumor's genomic profile, and among the patients receiving SoC. | 1 year after end of accrual and subsequently during follow up period of 5 years | 
| Quality of life assessment using EuroQol-5D (EQ-5D) in patients with metastatic breast cancer | The EuroQol EQ-5D is designed to assess health status in terms of a single index value or utility score. It contains 5 descriptors of current health state (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with each dimension having 5 levels of function (1=no problem, 2=slight problem, 3=moderate problem, 4=severe problem, and 5=unable/extreme). The scores on the 5 descriptors are summarized to create a single summary score. The EQ-5D also includes a visual analog scale (VAS), in which the patients self-rate their overall health status on a scale from 0 (worst imaginable) to 100 (best imaginable). | Ongoing basis during 3 years' patient recruitment | 
| Quality of life assessment using Functional Assessment of Cancer Therapy FACT-B in patients with metastatic breast cancer | The FACT-B consists of the Functional Assessment of Cancer Therapy-General (FACT-G) (27-items) and a breast-specific module: a 10-item instrument designed to assess patient concernsrelating to BC. The FACT-G is a 27-item compilation of general questions divided into 4 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Patients are asked to respond to a Likert scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. | Ongoing basis during 3 years' patient recruitment |