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Metastatic Breast CancerAGATANCT02445482

SOLTI Breast Cancer Molecular Screening Program (AGATA)

An observational study of Metastatic Breast Cancer, run by SOLTI Breast Cancer Research Group at 10 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In recent years, the advance in high-throughput techniques, such as microarrays and next gen sequencing (NGS) technologies, have allowed a more precise classification of the breast cancer molecular subtypes and a more personalized approach to anti-cancer therapy. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Biopsy
Type of treatment
Surgery or procedure
How many people
260 participants
Where
10 sitesSpain
Study dates
Oct 2014to Dec 2018
Phase
Observational
Are there results?
None posted in the registry

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study will be conducted in eight sites located in Spain, and up to 260 patients with advanced or metastatic breast cancer will be screened. These patients will be about to receive, or receiving, or will have received treatment for their disease in either a clinical trial or the healthcare setting

Who may be able to join

  • Female or Male patients
  • Between 18 and 70 years of age
  • Signed informed consent prior to any screening procedure
  • Advanced or Metastatic breast cancer of any subtype confirmed both pathologically and radiologically (stage IIIb- IV disease)
  • The patient may present with a responding, stable or progressive 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
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  • Availability of one archived initial or metastatic tumor sample. If archived material were not available, a biopsy of the metastatic cancer should be performed to obtain such material.
  • Measurable or non-measurable disease
  • Quality of life score according to ECOG scale ≤ 2
  • Minimal life expectancy of 3 months

Who cannot join

  • Presence of progressive disease at the time of inclusion requiring treatment initiation before genomic profile results are obtained
  • LVEF<50% (MUGA)
  • Inadequate bone marrow reserve or organ dysfunction shown by any of the following laboratory values:
  • Absolute neutrophil count
  • Platelet count< 100 x 109/L
  • Hemoglobin < 90 g/dL
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  • AST/ALT > 2.5 times the upper limit of normality if no demonstrable hepatic metastases, or > 5 times the upper limit of normality in the presence of hepatic metastases
  • Total bilirubin > 1.5 times the upper limit of normality
  • Creatinine>1.5 times the upper limit of normal
  • Corrected calcium > upper limit of normality
  • Phosphate > upper limit of normality
  • Presence of any other type of cancer, except suitably

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Spain10 sites

  • Hospital Clínic de Barcelona

    Barcelona

  • Hospital Universitari Vall d' Hebrón

    Barcelona

  • Institut Català d' Oncologia de Girona

    Girona

  • Institut Català d' Oncologia

    L'Hospitalet de Llobregat, Barcelona

  • Complejo Integral Oncologico Clara Campal

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands

  • Hospital Universitario Virgen del Rocio

    Seville

  • Hoapital Universitario Arnau de Vilanova

    Valencia

  • Hospital Universitario Clinic de Valencia

    Valencia

Other trials in Spain

About this study

Official title: SOLTI Molecular Screening Program: a Pilot Study to Implement Personalized Therapy for Patients With Advanced or Metastatic Breast Cancer

In recent years, the advance in high-throughput techniques, such as microarrays and next gen sequencing (NGS) technologies, have allowed a more precise classification of the breast cancer molecular subtypes and a more personalized approach to anti-cancer therapy. To date, conventional methods to select patients for clinical trials with anti-targeted agents according to molecular criteria are generally limited to the analysis of a few biomarkers. Recent studies have shown how this strategy is inappropriate in case of infrequent molecular alterations and that the ideal strategy would consist in simultaneous examination of large numbers of actionable genomic alterations.

This is the first genomic screening platform ever attempted in Spain. By this molecular platform SOLTI aims to increase the likelihood of a patient being included in a trial designed specifically for her molecular tumor type. Thus, the primary objective of this pilot study is to determine the Platform's effectiveness to include patients in clinical trials with targeted agents based on the tumor molecular profiling.

Read the detailed description

This is a prospective, multicenter, pilot study conducted in eight sites located in Spain. Up to 260 female or male patients, between 18-70 years with advanced or metastatic breast cancer will be screened. These patients will be about to receive, or receiving, or will have received treatment for their disease in either a clinical trial or the healthcare setting. Quality of life score according to ECOG scale ≤ 2 and a minimal life expectancy of 3 months. Upon signed inform consent and confirmation of eligibility criteria, tumor samples will be obtained from the patients either by biopsy of metastatic cancer or from archived tissue previously available at the site, and their genomic profile will be analyzed. It will be assessed the mutational status of a panel of genes considered relevant to the tumor biology and treatment. Detected variants /mutations in samples will not be classified according to their origin somatic or germline, since no normal paired DNA will be analyzed. Should any clinical trial match the patient's molecular profile, she/he will be offered to participate in it and the available samples left after sequencing will be supplied when a central confirmation would be requested. The patient's clinical data will be collected on a quarterly basis until death or consent withdrawal.

Mutation testing will be carried out at three laboratories experienced in high-throughput sequencing techniques: the VHIO Cancer Genomics Core laboratory of Barcelona, at Genomics Laboratory of the Research Institute of the Doce de Octubre University Hospital of Madrid and at the Genomics laboratory of the University Clinical Hospital of Valencia. There is a need to join efforts, set standards and optimize procedures for the benefit of all patients, so that the opportunity to participate in a genomic screening program can be offered to the great majority of hospitals that lack the technology required for these tests.

Being tested
Biopsy
Medical subject headings
Breast Neoplasms

What participants receive

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

  • BiopsyProcedure or surgery

    archival tissue or fresh biospsy

What is being measured

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

  1. Platform's effectiveness mesured as the proportion of patients included in clinical trials with targeted agents based on the tumor molecular profiling

    Measured: 30 months

Secondary outcomes (5)

  1. Characterization of the genomic profiles of the breast cancer patients included in the program listing the percentage of mutations deemed potentially actionable

    Measured: 30 months

  2. List of the potential barriers of the program

    Measured: 30 months

  3. Comparison of the percentage of patients included in clinical trials according to their genomic profile between the different panels and sequencing methods.

    Measured: 30 months

  4. Percentage of the patients alive and without progression (PFS) and percentage of patients alive (OS) of the patients receiving any targeted therapy based on molecular profiling

    Measured: 30 months

  5. Comparison of the PFS and OS percentages of patients included in clinical trials according to the genomic profile of their tumor with those of patients not assigned to these clinical trials

    Measured: 30 motnhs

Timeline

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

  1. First posted15 May 2015 (estimated)
  2. Study startOct 2014
  3. Primary completionJun 2017
  4. Study completionDec 2018

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
Cohort
Time perspective
Prospective
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02445482
Sponsor's protocol ID
SOLTI-1301
Acronym
AGATA
Status last verified
Jan 2019
First submitted
13 Jan 2015
Last updated
9 Jan 2019
Results posted
No
Data monitoring committee
No

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 10 sites 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 10 inclusion and 12 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: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Platform's effectiveness mesured as the proportion of patients included in clinical trials with targeted agents based on the tumor molecular profiling (time frame: 30 months). 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 NCT02445482.

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 9 Jan 2019.

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