Clinical trial NCT04497285: Real World Study Using Comprehensive Genomic Data on the Next Treatment Decision Making in Metastatic Breast Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Breast Cancer
Lead sponsor: SOLTI Breast Cancer Research Group
Sponsor class: OTHER
Collaborators: name: Novartis
name: Roche Pharma AG
name: Guardant Health, Inc.
First posted: 2020-08-04
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Metastatic breas cancer

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Metastatic breast cancer management based on tumor molecular profile
timeFrame: 1 year after end of accrual
Secondary outcomes:
measure: Description of the genetic mutational profile in tumor tissue.
timeFrame: Ongoing basis during 3 years' patient recruitment
measure: Description of the genetic mutational profile in blood samples
timeFrame: Ongoing basis during 3 years' patient recruitment
measure: Description of the enrollment rate of the study
timeFrame: Ongoing basis during 3 years' patient recruitment
measure: Feasibility of implementing the program for metastatic breast cancer
timeFrame: 1 year after end of accrual and subsequently during follow up period of 5 years
measure: Correlation between efficacy endpoints among patients enrolled in clinical trials according to the tumor's genomic profile and among patients receiving SoC.
timeFrame: 1 year after end of accrual and subsequently during follow up period of 5 years
measure: Quality of life assessment using EuroQol-5D (EQ-5D) in patients with metastatic breast cancer
timeFrame: Ongoing basis during 3 years' patient recruitment
measure: Quality of life assessment using Functional Assessment of Cancer Therapy FACT-B in patients with metastatic breast cancer
timeFrame: Ongoing basis during 3 years' patient recruitment
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Translational Genomics and Targeted Therapeutics in Solid Tumours Lab in August Pi i Sunyer Biomedical Research Institute (IDIBAPS)
state: Please Select
Study officials:
References: