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

NCT04497285 | Active Not Recruiting

• 1 other identifier: SOLTI-1903
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Description of the genetic mutational profile in tumor tissue.

  Ongoing basis during 3 years' patient recruitment

• Description of the genetic mutational profile in blood samples

  Ongoing basis during 3 years' patient recruitment

• Description of the enrollment rate of the study

  Ongoing basis during 3 years' patient recruitment

• Feasibility of implementing the program for metastatic breast cancer

  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.

  1 year after end of accrual and subsequently during follow up period of 5 years

Interventions

blood sample collection and collection of tumor tissue block OTHER

blood sample collection and collection of tumor tissue block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Metastatic breas cancer

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SOLTI Breast Cancer Research Group: lead
• Novartis: collaborator
• Roche Pharma AG: collaborator
• Guardant Health, Inc.: collaborator

Study Sites (1)

Translational Genomics and Targeted Therapeutics in Solid Tumours Lab in August Pi i Sunyer Biomedical Research Institute (IDIBAPS)

Barcelona, Please Select, 08008, Spain

Location

Related Publications (1)

• Olivera-Salguero R, Segui E, Cejalvo JM, Oliveira M, Tolosa P, Vidal M, Malumbres M, Gavila J, Saura C, Pernas S, Lopez R, Margeli M, Balmana J, Munoz M, Blancas I, Boni V, Ciruelos E, Galve E, Perello A, Sanchez-Bayona R, de la Cruz S, de la Hoya M, Galvan P, Sanfeliu E, Gonzalez-Farre B, Sirenko V, Blanch-Torras A, Canes J, Masanas H, Olmos R, Forns M, Prat A, Casas A, Pascual T. HOPE (SOLTI-1903) breast cancer study: real-world, patient-centric, clinical practice study to assess the impact of genomic data on next treatment decision-choice in patients with locally advanced or metastatic breast cancer. Front Oncol. 2023 Apr 28;13:1151496. doi: 10.3389/fonc.2023.1151496. eCollection 2023.

  PMID: 37188177 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood sample collection and collection of tumor tissue block

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: August 4, 2020
• Study Start: October 20, 2020
• Primary Completion: July 30, 2023
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

ES (1)