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

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ClinicalTrials.gov Identifier: NCT03524430
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Rna Diagnostics Inc.

Brief Summary:
The current study (BREVITY) 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)
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : April 26, 2025
Estimated Study Completion Date : October 26, 2025

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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;
  • Stage IV breast cancer;
  • Bilateral, multifocal or multicentric breast tumour;
  • Prior malignant disease except curatively treated basalioma of the skin or pTis of the cervix uteri;
  • 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 ClinicalTrials.gov identifier (NCT number): NCT03524430


Contacts
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Contact: Sanaa Noubir, PhD 1-416-333-2931 snoubir@rnadiagnostics.com

Locations
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United States, Missouri
Washington University School of Medicine-Siteman Cancer Center Suspended
Saint Louis, Missouri, United States, 63130
Canada, Ontario
Sunnybrook Research Institute Suspended
Toronto, Ontario, Canada
Italy
ASST ddi Cremona U.O. Multidisciplinare die Patologia Mammaria Recruiting
Cremona, Italy
Sponsors and Collaborators
Rna Diagnostics Inc.
Investigators
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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: Maureen Trudeau, MD Sunnybrook Health Sciences Center, Toronto, Canada
Publications:

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Responsible Party: Rna Diagnostics Inc.
ClinicalTrials.gov Identifier: NCT03524430    
Other Study ID Numbers: RnaDx-BRV-BC- 01
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
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
Neoplasms
Breast Diseases
Skin Diseases