Status:
ACTIVE_NOT_RECRUITING
Real World Study Using Comprehensive Genomic Data on the Next Treatment Decision Making in Metastatic Breast Cancer
Lead Sponsor:
SOLTI Breast Cancer Research Group
Collaborating Sponsors:
Novartis
Roche Pharma AG
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 20 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04497285
Start Date
October 20 2020
End Date
November 30 2026
Last Update
August 6 2025
Active Locations (1)
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1
Translational Genomics and Targeted Therapeutics in Solid Tumours Lab in August Pi i Sunyer Biomedical Research Institute (IDIBAPS)
Barcelona, Please Select, Spain, 08008