RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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
Primary outcome measure(s)
- Pathological complete response (pCR) — At surgery after completion of neoadjuvant therapy
(ypT0,ypN0) / (ypTis,ypN0)
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Siteman Cancer Center | St Louis | Missouri | |
| 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 |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03524430 on ClinicalTrials.gov ↗ ← All trials in Italy