SOLTI Breast Cancer Molecular Screening Program (AGATA)

NCT02445482 | Completed

• 1 other identifier: SOLTI-1301
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 10

Brief 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. 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

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

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

  30 months

Secondary Outcomes (5)

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

  30 months

• List of the potential barriers of the program

  30 months

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

  30 months

• 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

  30 months

• 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

  30 motnhs

Interventions

Biopsy PROCEDURE

archival tissue or fresh biospsy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SOLTI Breast Cancer Research Group: lead

Study Sites (10)

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

Location

Institut Català d' Oncologia

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Hospital Universitari Vall d' Hebrón

Barcelona, Spain

Location

Institut Català d' Oncologia de Girona

Girona, Spain

Location

Complejo Integral Oncologico Clara Campal

Madrid, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, Spain

Location

Hoapital Universitario Arnau de Vilanova

Valencia, Spain

Location

Hospital Universitario Clinic de Valencia

Valencia, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Collection of the archived initial or metastatic tumor sample (one 60 μm formalin-fixed, paraffin-embedded tumor block). If archived material is not available, a biopsy of the metastatic cancer should be performed to obtain such material

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Eva Ciruelos, MD

  SOLTI Breast Cancer Research Group

  PRINCIPAL INVESTIGATOR

• Sonia Pernas, MD

  SOLTI Breast Cancer Research Group

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: May 15, 2015
• Study Start: October 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2018
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

ES (10)