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Trial record 1 of 1 for:    RnaDx -BRV-BC-01
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RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy (BREVITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03524430
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : March 22, 2024
Information provided by (Responsible Party):
Rna Diagnostics Inc.

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Female Procedure: Core needle biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 594 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy (BREVITY / BREVITY-02 in Germany)
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Pathological complete response (pCR) [ Time Frame: At surgery after completion of neoadjuvant therapy ]
    (ypT0,ypN0) / (ypTis,ypN0)

Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 5 years of survival follow-up ]
    Time between diagnosis and first event of progression or death

  2. Residual Cancer Burden [ Time Frame: At surgery ]
    RCB Class

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03524430

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Contact: Sanaa Noubir, PhD 1-416-333-2931
Contact: John Connolly 1-416-985-4361

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United States, Missouri
Siteman Cancer Center Recruiting
Saint Louis, Missouri, United States, 63129
Sunnybrook Health Sciences Center Recruiting
Toronto, Canada
Institut de Cancerologie de Strasbourg Recruiting
Strasbourg, France
Universitätsklinikum Münster Recruiting
Münster, Germany
SST di Cremona Multidisciplinare di Patologia Mammaria, Italy Recruiting
Cremona, Italy
NZOZ Neuromed Recruiting
Lublin, Poland
Hospital U. 12 de Octubre Recruiting
Madrid, Spain
Sponsors and Collaborators
Rna Diagnostics Inc.
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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
Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: Rna Diagnostics Inc. Identifier: NCT03524430    
Other Study ID Numbers: RnaDx-BRV-BC- 01
RnaDx-BRV-BC- 02 (for Germany) ( Other Identifier: Rna Diagnostics Inc. )
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: March 22, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rna Diagnostics Inc.:
Breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases