RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy
Running, not enrolling · Not applicable
Conditions studied: Breast Neoplasm Female
In brief
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.
Key facts
- Study ID
- NCT03524430
- Run by
- Rna Diagnostics Inc.
- People needed
- 801
- Starts
- 2018-04-26
- Expected to finish
- 2031-05-22
- Last updated by the study team
- 2026-05-28
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women aged at least 18 years;
- Patients must be able to provide informed consent and sign the informed consent form to participate in the RDA study before any study procedures starts;
- Newly diagnosed clinical stage I, II or III breast cancer with complete surgical excision of the breast cancer after neoadjuvant therapy as the treatment goal;
- Tumour size at least 1 cm in one dimension by clinical or radiographic exam (WHO criteria);
- Must have histological confirmation of invasive breast cancer of any subtype or grade;
- Patient is scheduled for neoadjuvant chemotherapy +/- antibodies and +/- other drugs according to Standard of Care;
- Patient willing to have 2 research core needle biopsies (for RDA) taken at 2 collection timepoints during neoadjuvant chemotherapy treatment.
You may not qualify if…
- Patient who has had prior local (i.e. surgery or radiotherapy) or systemic (i.e. endocrine or cytotoxic) therapy for the current breast cancer;
- Participation in another interventional clinical trial with concurrent treatment with experimental drugs to treat the current breast cancer during the period of neoadjuvant therapy (from diagnosis until surgery);
- Stage IV breast cancer;
- Bilateral or multicentric breast tumour;
- Prior malignant disease except curatively treated in-situ maligancies;
- Concurrent pregnancy;
- Breast feeding woman;
- Concurrent medical, psychiatric or addictive disorders that may limit the ability to give informed consent or complete the trial;
- Reasons indicating risk of poor compliance with study procedures;
- Patient not able to consent;
Where it is running
- 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
Full record on ClinicalTrials.gov
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