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NCT03524430

RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy

Active, Not Recruiting
NAAges 18+InterventionalDiagnostic
Rna Diagnostics Inc.
~801 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:Core needle biopsy

At a glance

Recruiting sites
0 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pathological complete response (pCR)
Measured over At surgery after completion of neoadjuvant therapy

Conditions

Breast Neoplasm Female

Explore related trials

Breast Carcinoma

Where it's being run

7 sites across 7 states
Missouri1
Canada1
France1
Germany1
Italy1
Poland1
Spain1

Study leadership

  • Maureen Trudeau, MD · PRINCIPAL_INVESTIGATOR · Sunnybrook Health Sciences Center, Toronto, Canada
  • Daniele Generali, MD · PRINCIPAL_INVESTIGATOR · SST di Cremona Multidisciplinare di Patologia Mammaria, Italy
  • Foluso Ademuyiwa, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine, St Louis, USA
  • Thierry Petit, MD · PRINCIPAL_INVESTIGATOR · Institut de Cancérologie, Strasbourg, France
  • Joke Tio, MD · PRINCIPAL_INVESTIGATOR · Munster, Germany
  • Eva Ciruelos, MD · PRINCIPAL_INVESTIGATOR · Madrid, Spain
  • Tomasz Jankowski, MD · PRINCIPAL_INVESTIGATOR · NZOZ Neuromed, Lublin, Poland

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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;

What this trial measures

  • Pathological complete response (pCR)At surgery after completion of neoadjuvant therapy

    (ypT0,ypN0) / (ypTis,ypN0)