Evaluating RNA Disruption Assay for Breast Cancer Treatment Response

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

This study is testing a new method to see if it can help doctors tell how well chemotherapy is working for women with breast cancer before surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 801 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Rna Diagnostics Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 7 sites (St Louis, Missouri and 6 other locations)
• Trial ID: NCT03524430 on ClinicalTrials.gov

What this trial studies

This study aims to validate the RNA Disruption Assay (RDA) as a tool for assessing tumor response in women undergoing neoadjuvant chemotherapy for breast cancer. By analyzing tumor core biopsies taken approximately 35 days after treatment initiation, the study seeks to differentiate between responders and non-responders to chemotherapy. The primary objective is to establish diagnostic cut-offs for predicting pathological complete response (pCR) and to evaluate the assay's performance across different breast cancer subtypes. The study will enroll around 801 patients to achieve these goals.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with newly diagnosed clinical stage I, II, or III breast cancer who are scheduled for neoadjuvant chemotherapy.

Not a fit: Patients who have received prior treatment for their breast cancer or those with non-invasive breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized treatment strategies for breast cancer patients, improving outcomes and survival rates.

How similar studies have performed: Other studies have shown promise in using similar response-guided approaches in cancer treatment, suggesting potential for success in this novel application.

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;

Where this trial is running

St Louis, Missouri and 6 other locations

• Siteman Cancer Center — St Louis, Missouri, United States (Recruiting)
• Sunnybrook Health Sciences Center — Toronto, Canada (Recruiting)
• Institut de Cancerologie de Strasbourg — Strasbourg, France (Recruiting)
• Universitätsklinikum Münster — Münster, Germany (Recruiting)
• SST di Cremona Multidisciplinare di Patologia Mammaria, Italy — Cremona, Italy (Recruiting)
• NZOZ Neuromed — Lublin, Poland (Recruiting)
• Hospital U. 12 de Octubre — Madrid, Spain (Recruiting)

Study contacts

• Principal investigator: Maureen Trudeau, MD — Sunnybrook Health Sciences Center, Toronto, Canada
• Study coordinator: Sanaa Noubir, PhD

Conditions Breast Neoplasm Female; Breast cancer