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Metastatic Breast CancerHOPENCT04497285

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

An observational study of Metastatic Breast Cancer, run by SOLTI Breast Cancer Research Group at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
blood sample collection and collection of tumor tissue block
How many people
600 participants
Where
1 siteSpain
Study dates
20 Oct 2020to 30 Nov 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Metastatic breas cancer

Who may be able to join

  • 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.
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  • Measurable or non-measurable disease.
  • Quality of life score according to ECOG scale ≤ 3.
  • Minimal life expectancy of 6 months.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

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

    Barcelona, Please Select, 08008

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
blood sample collection and collection of tumor tissue block
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood sample collection and collection of tumor tissue blockOther

    blood sample collection and collection of tumor tissue block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Metastatic breast cancer management based on tumor molecular profile

    The number of patients assigned to different treatments based on the genomic profile.

    Measured: 1 year after end of accrual

Secondary outcomes (7)

  1. Description of the genetic mutational profile in tumor tissue.

    To describe the genetic mutational profile of the patients using Foundation One CDx.

    Measured: Ongoing basis during 3 years' patient recruitment

  2. Description of the genetic mutational profile in blood samples

    To describe the genetic mutational profile of the patients using liquid biopsy (Guardant360 test).

    Measured: Ongoing basis during 3 years' patient recruitment

  3. 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).

    Measured: Ongoing basis during 3 years' patient recruitment

  4. 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.

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

  5. 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.

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

  6. 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).

    Measured: Ongoing basis during 3 years' patient recruitment

  7. 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.

    Measured: Ongoing basis during 3 years' patient recruitment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2020
  2. Study start20 Oct 2020
  3. Primary completion30 Jul 2023
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04497285
Sponsor's protocol ID
SOLTI-1903
Acronym
HOPE
Status last verified
Aug 2025
First submitted
3 Jul 2020
Last updated
6 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37188177

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Breast Cancer, run by SOLTI Breast Cancer Research Group at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metastatic breast cancer management based on tumor molecular profile (time frame: 1 year after end of accrual). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04497285, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.

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