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

Launched by RNA DIAGNOSTICS INC. · May 2, 2018

Keywords

ClinConnect Summary

This clinical trial, called the RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy, is studying a new way to assess how well breast cancer treatment is working. Specifically, it looks at tumor samples taken from women with newly diagnosed breast cancer after they have started a specific type of chemotherapy known as neoadjuvant therapy. The goal is to see if the RNA Disruption Assay can help doctors better understand each patient’s response to treatment and make more personalized decisions moving forward.

To participate in this trial, women must be at least 18 years old, have confirmed invasive breast cancer that is stage I, II, or III, and be scheduled to start neoadjuvant chemotherapy. Participants will need to undergo two special biopsies (a procedure to take small samples of the tumor) during their treatment. This study is actively recruiting, so if someone meets the eligibility criteria, they can learn more about how to participate. It’s important to note that women who have previously received treatment for their breast cancer or are pregnant cannot join the trial.

Gender

FEMALE

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 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;