RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy
RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy (BREVITY / BREVITY-02 in Germany)
Rna Diagnostics Inc.
801 participants
Apr 26, 2018
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
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)
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NCT03524430