Clinical trial · Interventional
RNA Disruption Assay (RDA) Response Prediction in Neoadjuvant Chemotherapy Breast Cancer Treatment
Tumor RNA Disruption Assay as a Tool to Predict Response to Neoadjuvant Chemotherapy in Breast Cancer: Optimizing Timing of Biopsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the optimal time to use the Tumor RNA Disruption Assay (RDA) as a predictor of pathological complete response (pCR) in patients with breast cancer treated with neoadjuvant chemotherapy. This is important because the earlier non-responders are identified, the greater is the impact of reducing side effects of ineffective treatments. The study hypothesis is that the RDA score will accurately predict for tumor response after one cycle of chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor RDA biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Tumor RDA biopsy
- description
- Tumor RDA score measured from an FNA biopsy after cycle 1-2-3 of neoadjuvant chemotherapy and after first cycle of second chemotherapy agent if palpable tumour present.
- interventionNames
- Device: Tumor RDA biopsy
Primary outcomes (1)
- measure
- Pathologic complete response (pCR).
- timeFrame
- At time of surgery (4-8 months after first dose of neoadjuvant therapy).
- description
- Determine the optimal time at which Tumor RNA Disruption Assay (RDA) can predict pathological complete response (pCR) in patients with breast cancer treated with neoadjuvant chemotherapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be female. * Patients must be 18 years of age or older. * Patients with stage I, II, or III breast cancer that is greater or equal to 2 cm on clinical examination. * Patients that have biopsy proven invasive breast cancer diagnosed by core needle biopsy * Patients who are chemotherapy and radiotherapy naïve for the treatment of the current breast cancer. * Patients that accept to undergo neoadjuvant chemotherapy. * Patients with bilateral breast cancer are eligible. * Patients that understand, accept, and have signed the approved written consent form. * Patients will need to consent to be part of the study. Exclusion Criteria: Patients with one or more of the following conditions are ineligible for this study: * Patients who have had previous surgery, chemotherapy or radiotherapy for the current breast cancer * Patients who are pregnant or breast feeding. * Psychiatric or addictive disorders or conditions or social factors that may preclude the patient from meeting study requirements.
References
Publications (1)
- BACKGROUNDParissenti AM, Chapman JA, Kahn HJ, Guo B, Han L, O'Brien P, Clemons MP, Jong R, Dent R, Fitzgerald B, Pritchard KI, Shepherd LE, Trudeau ME. Association of low tumor RNA integrity with response to chemotherapy in breast cancer patients. Breast Cancer Res Treat. 2010 Jan;119(2):347-56. doi: 10.1007/s10549-009-0531-x. PMID 19771508