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

May 25, 2026 updated by: Rna Diagnostics Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Rationale:

There is some evidence that identifying non-responders early in neoadjuvant treatment and offering alternative agents (response-guided therapy) increased pathological complete response (pCR) rates and/or survival resulting in improved care and incremental cost effectiveness.

Differentiating non-responders to chemotherapy from responders with reliable guidance tools early during therapy is crucial to the success of response-guided therapy.

The current study aims to provide validation results of RDA as a tumor response assessment tool that uses tumor core biopsies starting from 35 +/- 4 days after the initiation of neoadjuvant chemotherapy.

Study Objectives and Endpoints:

The primary objective of the study is to determine the 2 RDI cut-offs to have a diagnostic test optimized in terms of both negative and positive predictive values NPV and PPV (in a training set of patients i.e. phase 1 of the study) for predicting nopCR/pCR and to establish the performance characteristics for the first cut-off (test result "zone 1") in terms of NPV as primary endpoint (in a validation set i.e. phase 2).

The secondary objective is to assess the test's NPV in the different cancer subtypes and the test's PPV in Her2+ patients; also to assess and compare pCR prevalence, residual cancer burden (RCB class at surgery) and DFS (secondary endpoints) in zones 1-3 for all patients and each cancer subtype.

Patient Population:

The study aims to enroll approximately 801 patients in centers in the US, Canada, Italy, Germany, Spain and France and Poland.

The population consists of patients diagnosed with invasive breast cancer and scheduled to receive neoadjuvant chemotherapy as part of standard of care treatment. Throughout the study, patients will receive standard of care neoadjuvant chemotherapy treatments including taxanes, anthracyclines or other targeted drugs and drug combinations as prescribed based on the investigators' / clinicians' choice. Adjuvant therapies (e.g. radiotherapy, hormonal treatment … etc.) may be prescribed to patients according to standard of care and independently of the RDI score results.

RDA is presently in an experimental stage and clinicians will not receive or use the RDA results in this study.

Biopsy Collection:

  • 1st core needle biopsy for RDA (2 specimens): Time Point: 35 +/- days after initiation of neoadjuvant chemotherapy;
  • 2nd core needle biopsy for RDA (2 specimens): Time Point: if therapy is changed (as part of SoC), a second biopsy ~2-3 weeks after initiation of new drugs; Timing by type of drug schedule 3-weekly: at 16 days +/- 2 days, Bi-weekly: at day of 2nd dose preferably before drug admin., Weekly: at day of 4th dose preferably before drug admin. If Therapy is not changed (as part of SoC), a second biopsy is taken at 55 +/- 5 days after the first initiation of neoadjuvant therapy.

Statistical Plan:

The study consists of a training set / phase 1 (80 fully evaluable patients) to determine response zone cut-offs using pCR outcomes and RDA's predictive values, and a validation set / phase 2 (454 fully evaluable patients) to validate the performance characteristics of the RDA test. The study aims to enroll 801 patients in order to achieve an accrual of 534 fully evaluable patients (phase 1 and 2) which is the number required to adequately statistically power the trial. Recruitment per subgroup of cancer subtypes will be closed when the target number of fully evaluable patients per subgroup is reached for both phase 1 and 2. Combined statistical analysis and various subgroup analyses will be performed for the primary and secondary objectives.

Duration and Follow-up:

There will be an active patient accrual until last patient is accrued (to achieve the required fully evaluable patient numbers) in addition to 60 months of patient follow-up.

Study Type

Interventional

Enrollment (Estimated)

801

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Toronto, Canada
        • Sunnybrook Health Sciences Center
  • France
      • Strasbourg, France
        • Institut de Cancérologie de Strasbourg
  • Germany
      • Münster, Germany
        • Universitätsklinikum Münster
  • Italy
      • Cremona, Italy
        • SST di Cremona Multidisciplinare di Patologia Mammaria, Italy
  • Poland
      • Lublin, Poland
        • NZOZ Neuromed
  • Spain
      • Madrid, Spain
        • Hospital U. 12 de Octubre
  • United States
    • Missouri
      • St Louis, Missouri, United States, 63129
        • Siteman Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Interventional Study Arm
There will be 2 biopsy collection time points with 2 core needle biopsy specimens taken at each biopsy collection time point for RDA analysis during neoadjuvant chemotherapy.
Procedure: Core needle biopsy

1st core needle biopsy for RDA (2 specimens): Time Point: 35 +/-4 days after initiation of chemotherapy.

If no change is made to the therapy, a second biopsy (2 specimens) will be performed at 55 +/- 5 days after therapy initiation.

If there is a change of drugs, the second biopsy (2 specimens) will be performed at ~2-3 weeks after initiation of new drugs; Timing by type of drug schedule 3-weekly: at 16 days +/- 2 days, Bi-weekly: at day of 2nd dose preferably before drug admin., Weekly: at day of 4th dose preferably before drug admin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete response (pCR)
Time Frame: At surgery after completion of neoadjuvant therapy
(ypT0,ypN0) / (ypTis,ypN0)
At surgery after completion of neoadjuvant therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 5 years of survival follow-up
Time between diagnosis and first event of progression or death
5 years of survival follow-up
Residual Cancer Burden
Time Frame: At surgery
RCB Class
At surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rna Diagnostics Inc.

Investigators

  • Principal Investigator: Maureen Trudeau, MD, Sunnybrook Health Sciences Center, Toronto, Canada
  • Principal Investigator: Daniele Generali, MD, SST di Cremona Multidisciplinare di Patologia Mammaria, Italy
  • Principal Investigator: Foluso Ademuyiwa, MD, Washington University School of Medicine, St Louis, USA
  • Principal Investigator: Thierry Petit, MD, Institut de Cancérologie, Strasbourg, France
  • Principal Investigator: Joke Tio, MD, Munster, Germany
  • Principal Investigator: Eva Ciruelos, MD, Madrid, Spain
  • Principal Investigator: Tomasz Jankowski, MD, NZOZ Neuromed, Lublin, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2018

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

May 22, 2031

Study Registration Dates

First Submitted

May 2, 2018

First Submitted That Met QC Criteria

May 2, 2018

First Posted (Actual)

May 14, 2018

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RnaDx-BRV-BC- 01
  • RnaDx-BRV-BC- 02 (for Germany) (Other Identifier: Rna Diagnostics Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe