BREVITY-02

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

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

 

Minimum Age: 18 Years

Sex: Female

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;
• Stage IV breast cancer;
• Bilateral, multifocal or multicentric breast tumour;
• Prior malignant disease except curatively treated basalioma of the skin or pTis of the cervix uteri;
• 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

Specifications

• Sponsor: Rna Diagnostics Inc.