Trial Details

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.

Official Title

RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy (BREVITY / BREVITY-02 in Germany)

Selection Criteria

Eligibility 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.

Eligibility 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;