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Active, not recruiting Not applicable

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

NCT03524430 · tracked via the Priya Life Science Italy tracker
Sponsor
Rna Diagnostics Inc
Phase
Not applicable
Started
2018-04-26
Last updated
2026-05-28

Condition(s) studied

Breast Neoplasm Female

Investigational drug(s) / intervention(s)

Core needle biopsy

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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria * 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 Criteria * 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;

Primary outcome measure(s)

  • Pathological complete response (pCR) — At surgery after completion of neoadjuvant therapy
    (ypT0,ypN0) / (ypTis,ypN0)

Trial sites (7)

FacilityCityRegionStatus
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

Official registry record

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