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RNA Disruption Assay for Breast Cancer (BREVITY Trial)

N/A

Recruiting

Led By Joke Tio

Research Sponsored by Rna Diagnostics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years of survival follow-up

Awards & highlights

BREVITY Trial Summary

This trial validates the RNA Disruption Assay as a tool to measure tumor response to neoadjuvant chemotherapy, using biopsies taken 35 days after treatment starts.

Who is the study for?

This trial is for women over 18 with stage I-III breast cancer, aiming to have surgery after chemotherapy. They must be able to consent and agree to two core needle biopsies during treatment. Excluded are those with stage IV cancer, concurrent serious conditions, prior treatments for current cancer, or in another drug trial.Check my eligibility

What is being tested?

The study tests the RNA Disruption Assay (RDA) as a tool to assess tumor response from biopsy samples taken during neoadjuvant chemotherapy. It aims to validate RDA's effectiveness in predicting treatment outcomes before surgical excision.See study design

What are the potential side effects?

While not directly related to medication side effects, undergoing core needle biopsies may result in pain at the biopsy site, bruising, bleeding or infection.

BREVITY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have stage I, II, or III breast cancer and aim for surgery after initial treatment.

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My tumor is at least 1 cm big.

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My breast cancer diagnosis was confirmed through tissue examination.

BREVITY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years of survival follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years of survival follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years of survival follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pathological complete response (pCR)

Secondary outcome measures

Disease-free survival

Residual Cancer Burden

BREVITY Trial Design

1Treatment groups

Experimental Treatment

Group I: Single Interventional Study ArmExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rna Diagnostics Inc.Lead Sponsor

Joke TioPrincipal InvestigatorMunster, Germany

Eva Ciruelos, MDPrincipal InvestigatorMadrid, Spain

4 Previous Clinical Trials

443 Total Patients Enrolled

1 Trials studying Breast Cancer

60 Patients Enrolled for Breast Cancer

Media Library

Core needle biopsy Clinical Trial Eligibility Overview. Trial Name: NCT03524430 — N/A

Breast Cancer Research Study Groups: Single Interventional Study Arm

Breast Cancer Clinical Trial 2023: Core needle biopsy Highlights & Side Effects. Trial Name: NCT03524430 — N/A

Core needle biopsy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03524430 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study open to participants at this time?

"This medical study, which was initially posted on April 26th 2018, is still looking for participants according to clinicaltrials.gov. The details of the trial were last updated on June 22nd 2022."

Answered by AI

How many individuals are currently eligible to participate in this research?

"Affirmative. According to the information held on clinicaltrials.gov, this experimental trial is proactively searching for 594 participants from 2 locations. This listing was initially published on April 26th 2018 and has been modified most recently on June 22nd 2022."

Answered by AI

Recent research and studies

Breast Cancer Research and TreatmentJournal

Tumor RNA Disruption Predicts Survival Benefit from Breast Cancer Chemotherapy

Parissenti, Amadeo M., Baoqing Guo, Laura B. Pritzker, Kenneth P. H. Pritzker, Xiaohui Wang, Mu Zhu, Lois E. Shepherd, and Maureen E. Trudeau. 2015. “Tumor RNA Disruption Predicts Survival Benefit from Breast Cancer Chemotherapy”. Breast Cancer Research and Treatment. Springer Science and Business Media LLC. doi:10.1007/s10549-015-3498-9.

BMC CancerJournal

RNA Disruption Is Associated with Response to Multiple Classes of Chemotherapy Drugs in Tumor Cell Lines

Narendrula, Rashmi, Kyle Mispel-Beyer, Baoqing Guo, Amadeo M. Parissenti, Laura B. Pritzker, Ken Pritzker, Twinkle Masilamani, Xiaohui Wang, and Carita Lannér. 2016. “RNA Disruption Is Associated with Response to Multiple Classes of Chemotherapy Drugs in Tumor Cell Lines”. BMC Cancer. Springer Science and Business Media LLC. doi:10.1186/s12885-016-2197-1.

Journal of the National Cancer InstituteJournal

RE: RNA Disruption Assay as a Biomarker of Pathological Complete Response in Neoadjuvant Trastuzumab-treated Human Epidermal Growth Factor Receptor 2–positive Breast Cancer

Toomey, Sinead, Alex J. Eustace, Laura B. Pritzker, Ken P. H. Pritzker, Joanna Fay, Anthony O’Grady, Robert Cummins, et al.. 2016. “RE: RNA Disruption Assay as a Biomarker of Pathological Complete Response in Neoadjuvant Trastuzumab-treated Human Epidermal Growth Factor Receptor 2–positive Breast Cancer”. Journal of the National Cancer Institute. Oxford University Press (OUP). doi:10.1093/jnci/djw111.

JNCI MonographsJournal