RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy BREVITY

Titre officiel

RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy (BREVITY)

Sommaire:

L’étude actuelle (BREVITY) vise à fournir les résultats de validation de l’épreuve biologique de la destruction de l’acide ribonucléique (épreuve RDA) comme outil d’évaluation de la réponse tumorale qui utilise des biopsies du noyau tumoral environ deux à trois semaines après le début de la chimiothérapie néoadjuvante.

Description de l'essai

Primary Outcome:

  • Pathological complete response (pCR)
Secondary Outcome:
  • Disease-free survival
Study Rationale: There is some evidence that identifying non-responders early in neoadjuvant treatment and offering alternative agents (response-guided therapy) increased pathological complete response (pCR) rates and/or survival resulting in improved care and incremental cost effectiveness. Differentiating non-responders to chemotherapy from responders with reliable guidance tools early during therapy is crucial to the success of response-guided therapy. The current study (BREVITY) aims to provide validation results of RDA as a tumour response assessment tool that uses tumour core biopsies starting from 35 +/- 4 days after the initiation of neoadjuvant chemotherapy. Study Objectives and Endpoints: The primary objective of the BREVITY study is to determine the 2 RDI cut-offs to have a diagnostic test optimized in terms of both negative and positive predictive values NPV and PPV (in a training set of patients i.e. phase 1 of the study) for predicting nopCR/pCR and to establish the performance characteristics for the first cut-off (test result "zone 1") in terms of NPV as primary endpoint (in a validation set i.e. phase 2). The secondary objective is to assess the test's NPV in the different cancer subtypes and the test's PPV in Her2+ patients; also to assess and compare pCR prevalence and DFS (secondary endpoint) in zones 1-3 for all patients and each cancer subtype. Patient Population: The study aims to enrol approximately 594 patients in centres in the US, Canada, Italy, Germany, Ireland, France and Austria. The population consists of patients diagnosed with invasive breast cancer and scheduled to receive neoadjuvant chemotherapy as part of standard of care treatment. Throughout the study, patients will receive standard of care neoadjuvant chemotherapy treatments including taxanes, anthracyclines or other targeted drugs and drug combinations as prescribed based on the investigators' / clinicians' choice. Adjuvant therapies (e.g. radiation therapy, hormonal treatment … etc.) may be prescribed to patients according to standard of care and independently of the RDI score results. RDA is presently in an experimental stage and clinicians will not receive or use the RDA results in this study. Biopsy Collection:
  • 1st core needle biopsy for RDA (2 specimens): Time Point: 35 +/- days after initiation of neoadjuvant chemotherapy;
  • 2nd core needle biopsy for RDA (2 specimens): Time Point: if therapy is changed (as part of SoC), a second biopsy
  • 2-3 weeks after initiation of new drugs; Timing by type of drug schedule 3-weekly: at 16 days +/- 2 days, Bi-weekly: at day of 2nd dose preferably before drug admin., Weekly: at day of 4th dose preferably before drug admin. If Therapy is not changed (as part of SoC), a second biopsy is taken at 55 +/- 5 days after the first initiation of neoadjuvant therapy. Statistical Plan: The study consists of a training set / phase 1 (80 fully evaluable patients) to determine response zone cut-offs using pCR outcomes and RDA's predictive values, and a validation set / phase 2 (454 fully evaluable patients) to validate the performance characteristics of the RDA test. The study aims to enrol 594 patients in order to achieve an accrual of 534 fully evaluable patients which is the number required to adequately statistically power the trial. Combined statistical analysis and various subgroup analyses will be performed for the primary and secondary objectives. Duration and Follow-up: There will be an 18 months of active patient accrual (or until last patient is accrued) in addition to 60 months of patient follow-up.
  • Voir cet essai sur ClinicalTrials.gov

Intéressé(e) par cet essai?

Imprimez cette page et apportez-la chez votre médecin pour discuter de votre admissibilité à cet essai et des options de traitement. Seul votre médecin peut vous recommander pour un essai clinique.

Ressources

Société canadienne du cancer

Ces ressources sont fournies en partenariat avec Société canadienne du cancer