RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy (BREVITY)
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ClinicalTrials.gov Identifier: NCT03524430 |
Recruitment Status :
Recruiting
First Posted : May 14, 2018
Last Update Posted : March 22, 2024
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Condition or disease | Intervention/treatment | Phase |
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Breast Neoplasm Female | Procedure: Core needle biopsy | Not Applicable |
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 |
Arm | Intervention/treatment |
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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.
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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. |
- Pathological complete response (pCR) [ Time Frame: At surgery after completion of neoadjuvant therapy ](ypT0,ypN0) / (ypTis,ypN0)
- Disease-free survival [ Time Frame: 5 years of survival follow-up ]Time between diagnosis and first event of progression or death
- Residual Cancer Burden [ Time Frame: At surgery ]RCB Class
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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;
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
Contact: Sanaa Noubir, PhD | 1-416-333-2931 | snoubir@rnadiagnostics.com | |
Contact: John Connolly | 1-416-985-4361 | jconnolly@rnadiagnostics.com |
United States, Missouri | |
Siteman Cancer Center | Recruiting |
Saint Louis, Missouri, United States, 63129 | |
Canada | |
Sunnybrook Health Sciences Center | Recruiting |
Toronto, Canada | |
France | |
Institut de Cancerologie de Strasbourg | Recruiting |
Strasbourg, France | |
Germany | |
Universitätsklinikum Münster | Recruiting |
Münster, Germany | |
Italy | |
SST di Cremona Multidisciplinare di Patologia Mammaria, Italy | Recruiting |
Cremona, Italy | |
Poland | |
NZOZ Neuromed | Recruiting |
Lublin, Poland | |
Spain | |
Hospital U. 12 de Octubre | Recruiting |
Madrid, Spain |
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 of Results:
Other Publications:
Responsible Party: | Rna Diagnostics Inc. |
ClinicalTrials.gov 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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Breast cancer |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |