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RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy
Sponsor: 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.
Official title: RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy (BREVITY / BREVITY-02 in Germany)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
801
Start Date
2018-04-26
Completion Date
2031-03-31
Last Updated
2025-10-14
Healthy Volunteers
No
Conditions
Interventions
Core 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 Center
St Louis, Missouri, United States
Sunnybrook Health Sciences Center
Toronto, Canada
Institut de Cancerologie de Strasbourg
Strasbourg, France
Universitätsklinikum Münster
Münster, Germany
SST di Cremona Multidisciplinare di Patologia Mammaria, Italy
Cremona, Italy
NZOZ Neuromed
Lublin, Poland
Hospital U. 12 de Octubre
Madrid, Spain