Clinical trial · Observational
SOLTI Breast Cancer Molecular Screening Program (AGATA)
SOLTI Molecular Screening Program: a Pilot Study to Implement Personalized Therapy for Patients With Advanced or Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Platform's effectiveness mesured as the proportion of patients included in clinical trials with targeted agents based on the tumor molecular profiling
- timeFrame
- 30 months
Secondary outcomes (5)
- measure
- Characterization of the genomic profiles of the breast cancer patients included in the program listing the percentage of mutations deemed potentially actionable
- timeFrame
- 30 months
- measure
- List of the potential barriers of the program
- timeFrame
- 30 months
- measure
- Comparison of the percentage of patients included in clinical trials according to their genomic profile between the different panels and sequencing methods.
- timeFrame
- 30 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available