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Recruiting NCT03524430

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

Trial Parameters

Condition Breast Neoplasm Female
Sponsor Rna Diagnostics Inc.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 801
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2018-04-26
Completion 2026-07-30
Interventions
Core needle biopsy

Brief 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 Criteria

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 ano

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