RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy (BREVITY / BREVITY-02 in Germany)
Rna Diagnostics Inc.
Summary
The current study aims to provide validation results of RNA Disruption Assay (RDA) as a tumour response assessment tool that uses tumour core biopsies taken starting from 35 +/- 4 days after the initiation of neoadjuvant chemotherapy.
Description
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 aims to provide validation results of RDA as a tumor response assessment tool that uses tumor core biopsies starting fr…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria * Women aged at least 18 years; * Patients must be able to provide informed consent and sign the informed consent form to participate in the RDA study before any study procedures starts; * Newly diagnosed clinical stage I, II or III breast cancer with complete surgical excision of the breast cancer after neoadjuvant therapy as the treatment goal; * Tumour size at least 1 cm in one dimension by clinical or radiographic exam (WHO criteria); * Must have histological confirmation of invasive breast cancer of any subtype or grade; * Patient is scheduled for neoadjuvant chemother…
Interventions
- ProcedureCore needle biopsy
1st core needle biopsy for RDA (2 specimens): Time Point: 35 +/-4 days after initiation of chemotherapy. If no change is made to the therapy, a second biopsy (2 specimens) will be performed at 55 +/- 5 days after therapy initiation. If there is a change of drugs, the second biopsy (2 specimens) will be performed at \~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.
Locations (7)
- Siteman Cancer CenterSt Louis, Missouri
- Sunnybrook Health Sciences CenterToronto
- Institut de Cancerologie de StrasbourgStrasbourg
- Universitätsklinikum MünsterMünster
- SST di Cremona Multidisciplinare di Patologia Mammaria, ItalyCremona
- NZOZ NeuromedLublin