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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Tracking Information | ||||||||||||||||||||||
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First Submitted Date ICMJE | May 2, 2018 | |||||||||||||||||||||
First Posted Date ICMJE | May 14, 2018 | |||||||||||||||||||||
Last Update Posted Date | March 22, 2024 | |||||||||||||||||||||
Actual Study Start Date ICMJE | April 26, 2018 | |||||||||||||||||||||
Estimated Primary Completion Date | June 30, 2024 (Final data collection date for primary outcome measure) | |||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
Pathological complete response (pCR) [ Time Frame: At surgery after completion of neoadjuvant therapy ] (ypT0,ypN0) / (ypTis,ypN0)
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Original Primary Outcome Measures ICMJE | Same as current | |||||||||||||||||||||
Change History | ||||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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Current Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||||||||
Descriptive Information | ||||||||||||||||||||||
Brief Title ICMJE | RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy | |||||||||||||||||||||
Official Title ICMJE | RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy (BREVITY / BREVITY-02 in Germany) | |||||||||||||||||||||
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. | |||||||||||||||||||||
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 tumour response assessment tool that uses tumour 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 enrol approximately 594 patients in centres in the US, Canada, Italy, Germany, Spain and France. 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:
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 enrol 594 patients in order to achieve an accrual of 534 fully evaluable patients which is the number required to adequately statistically power the trial. Combined statistical analysis and various subgroup analyses will be performed for the primary and secondary objectives. Duration and Follow-up: There will be an 18 months of active patient accrual (or until last patient is accrued) in addition to 60 months of patient follow-up. |
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Study Type ICMJE | Interventional | |||||||||||||||||||||
Study Phase ICMJE | Not Applicable | |||||||||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Breast Neoplasm Female | |||||||||||||||||||||
Intervention ICMJE | 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. |
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Study Arms ICMJE | 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.
Intervention: Procedure: Core needle biopsy
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||||||||
Recruitment Status ICMJE | Recruiting | |||||||||||||||||||||
Estimated Enrollment ICMJE |
594 | |||||||||||||||||||||
Original Estimated Enrollment ICMJE |
722 | |||||||||||||||||||||
Estimated Study Completion Date ICMJE | December 31, 2028 | |||||||||||||||||||||
Estimated Primary Completion Date | June 30, 2024 (Final data collection date for primary outcome measure) | |||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada, France, Germany, Italy, Poland, Spain, United States | |||||||||||||||||||||
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Administrative Information | ||||||||||||||||||||||
NCT Number ICMJE | NCT03524430 | |||||||||||||||||||||
Other Study ID Numbers ICMJE | RnaDx-BRV-BC- 01 RnaDx-BRV-BC- 02 (for Germany) ( Other Identifier: Rna Diagnostics Inc. ) |
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Has Data Monitoring Committee | Yes | |||||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Rna Diagnostics Inc. | |||||||||||||||||||||
Original Responsible Party | Same as current | |||||||||||||||||||||
Current Study Sponsor ICMJE | Rna Diagnostics Inc. | |||||||||||||||||||||
Original Study Sponsor ICMJE | Same as current | |||||||||||||||||||||
Collaborators ICMJE | Not Provided | |||||||||||||||||||||
Investigators ICMJE |
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PRS Account | Rna Diagnostics Inc. | |||||||||||||||||||||
Verification Date | March 2024 | |||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |