Clinical trial · Interventional
Study of Tumor RNA Disruption Assay™ (RDA)
Study of Tumor RNA Disruption Assay™ (RDA) and Its Association With a Response to Neoadjuvant Chemotherapy in Breast Cancer - A Prospective Mixed-Methods Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of funding
Summary
Brief summary (as posted)
The purpose of this study is to find out if the pathological complete response (pCR) to chemotherapy given before surgery (neoadjuvant chemotherapy) could be predicted by the evaluation of the RNA (ribonucleic acids) disruption pattern (RNA Disruption Assay or RDA score) obtained from a biopsy of the tumor 7 - 14 days after the first, second and third cycles of chemotherapy treatment. If we can determine the optimal time during neoadjuvant chemotherapy to measure the RDA score for the prediction of pCR, we can optimize breast cancer management.
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 |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor RNA Disruption Assay™ (RDA) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tumor RNA Disruption Assay™ (RDA)
- description
- Tumor RNA Disruption Assay™ (RDA) to generate RDA score from fine needle aspiration biopsy samples of breast cancer obtained 7-14 days after the first, second and third cycles of neoadjuvant chemotherapy; and, if there is a change of chemotherapy regimen, after the first cycle of the new chemotherapy.
- interventionNames
- Other: Tumor RNA Disruption Assay™ (RDA)
Primary outcomes (1)
- measure
- The association between RDA score and pathological complete response (pCR)
- timeFrame
- An expected average of 6 months
- description
- The association between tumor RDA score measured 7-14 days after the first, second and third cycles of chemotherapy and the pCR to neoadjuvant chemotherapy will be evaluated. pCR is defined as no evidence of invasive carcinoma in the breast and lymph nodes (ypT0/Tis ypN0/N0itc) on histology at the time of surgery (lumpectomy or mastectomy).
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female,18 years or older; * Able to read and write in English: * With palpable cancer \> 2cm (T2, T3) on clinical examination or clinical diagnosis of locally advanced breast cancer (LABC) (T3 or T4; or N2 or N3, according to TNM cancer staging including inflammatory breast cancer); * Must have histological proof of breast cancer (invasive ductal or infiltrating lobular); * Scheduled to receive neoadjuvant chemotherapy as part of their treatment plan; * Agree to have FNAB after the first, second and third cycle of chemotherapy, and if the chemotherapy regimen is changed, an additional FNAB after the first cycle of the new chemotherapy. Exclusion Criteria: * Subjects who have had surgery, neoadjuvant chemotherapy or radiotherapy for the current breast cancer; * Subjects who are pregnant or breast feeding; * Subjects with Stage IV breast cancer; * Psychiatric or addictive disorders that may limit the ability to give informed consent or complete the trial.
References
Publications (3)
- 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
- BACKGROUNDSchroeder A, Mueller O, Stocker S, Salowsky R, Leiber M, Gassmann M, Lightfoot S, Menzel W, Granzow M, Ragg T. The RIN: an RNA integrity number for assigning integrity values to RNA measurements. BMC Mol Biol. 2006 Jan 31;7:3. doi: 10.1186/1471-2199-7-3. PMID 16448564
- BACKGROUNDGuidance for Industry- Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval (May 2012). US DHHS FDA CDER; Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM305501.pdf