Breast Neoplasm FemaleBREVITYNCT03524430
RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy
A study testing Core needle biopsy in people with Breast Neoplasm Female, run by Rna Diagnostics Inc. at 7 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm Female
- What is being tested?
- Core needle biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 801 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 26 Apr 2018to 22 May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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;
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
Italy1 site
SST di Cremona Multidisciplinare di Patologia Mammaria, Italy
Cremona
About this study
Official title: RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy (BREVITY / BREVITY-02 in Germany)
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.
Read the 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 tumor response assessment tool that uses tumor 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 enroll approximately 801 patients in centers in the US, Canada, Italy, Germany, Spain and France and Poland.
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:
- 1st core needle biopsy for RDA (2 specimens): Time Point: 35 +/- days after initiation of neoadjuvant chemotherapy;
- 2nd core needle biopsy for RDA (2 specimens): Time Point: if therapy is changed (as part of SoC), a second biopsy ~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. If Therapy is not changed (as part of SoC), a second biopsy is taken at 55 +/- 5 days after the first initiation of neoadjuvant therapy.
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 enroll 801 patients in order to achieve an accrual of 534 fully evaluable patients (phase 1 and 2) which is the number required to adequately statistically power the trial. Recruitment per subgroup of cancer subtypes will be closed when the target number of fully evaluable patients per subgroup is reached for both phase 1 and 2. Combined statistical analysis and various subgroup analyses will be performed for the primary and secondary objectives.
Duration and Follow-up:
There will be an active patient accrual until last patient is accrued (to achieve the required fully evaluable patient numbers) in addition to 60 months of patient follow-up.
- Conditions
- Breast Neoplasm Female
- Being tested
- Core needle biopsy
- Keywords
- Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core needle biopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Interventional Study Arm | Experimental | 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. Receives: Procedure: Core needle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR)
(ypT0,ypN0) / (ypTis,ypN0)
Measured: At surgery after completion of neoadjuvant therapy
Secondary outcomes (2)
Disease-free survival
Time between diagnosis and first event of progression or death
Measured: 5 years of survival follow-up
Residual Cancer Burden
RCB Class
Measured: At surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start26 Apr 2018
- Primary completion30 Oct 2026 (estimated)
- Study completion22 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 801 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rna Diagnostics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maureen Trudeau, MD, Principal investigator, Sunnybrook Health Sciences Center, Toronto, CanadaDaniele Generali, MD, Principal investigator, SST di Cremona Multidisciplinare di Patologia Mammaria, ItalyFoluso Ademuyiwa, MD, Principal investigator, Washington University School of Medicine, St Louis, USAThierry Petit, MD, Principal investigator, Institut de Cancérologie, Strasbourg, FranceJoke Tio, MD, Principal investigator, Munster, GermanyEva Ciruelos, MD, Principal investigator, Madrid, SpainTomasz Jankowski, MD, Principal investigator, NZOZ Neuromed, Lublin, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524430
- Sponsor's protocol ID
- RnaDx-BRV-BC- 01
- Other IDs
- RnaDx-BRV-BC- 02 (for Germany)
- Acronym
- BREVITY
- Status last verified
- May 2026
- First submitted
- 2 May 2018
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parissenti AM, Guo B, Pritzker LB, Pritzker KP, Wang X, Zhu M, Shepherd LE, Trudeau ME. Tumor RNA disruption predicts survival benefit from breast cancer chemotherapy. Breast Cancer Res Treat. 2015 Aug;153(1):135-44. doi: 10.1007/s10549-015-3498-9. Epub 2015 Jul 25.
PubMed 26208483Narendrula R, Mispel-Beyer K, Guo B, Parissenti AM, Pritzker LB, Pritzker K, Masilamani T, Wang X, Lanner C. RNA disruption is associated with response to multiple classes of chemotherapy drugs in tumor cell lines. BMC Cancer. 2016 Feb 24;16:146. doi: 10.1186/s12885-016-2197-1.
PubMed 26911141Toomey S, Eustace AJ, Pritzker LB, Pritzker KP, Fay J, O'Grady A, Cummins R, Grogan L, Kennedy J, O'Connor D, Young L, Kay EW, O'Donovan N, Gallagher WM, Kalachand R, Crown J, Hennessy BT. RE: RNA Disruption Assay as a Biomarker of Pathological Complete Response in Neoadjuvant Trastuzumab-Treated Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer. J Natl Cancer Inst. 2016 Jul 4;108(8):djw111. doi: 10.1093/jnci/djw111. Print 2016 Aug. No abstract available.
PubMed 27377904Pritzker K, Pritzker L, Generali D, Bottini A, Cappelletti MR, Guo B, Parissenti A, Trudeau M. RNA Disruption and Drug Response in Breast Cancer Primary Systemic Therapy. J Natl Cancer Inst Monogr. 2015 May;2015(51):76-80. doi: 10.1093/jncimonographs/lgv015.
PubMed 26063893Cazzaniga ME, Ademuyiwa F, Petit T, Tio J, Generali D, Ciruelos EM, Califaretti N, Poirier B, Ardizzoia A, Hoenig A, Lex B, Mouret-Reynier MA, Giesecke D, Isambert N, Masetti R, Pitre L, Wrobel D, Augereau P, Milani M, Rask S, Solbach C, Pritzker L, Noubir S, Parissenti A, Trudeau ME. Low RNA disruption during neoadjuvant chemotherapy predicts pathologic complete response absence in patients with breast cancer. JNCI Cancer Spectr. 2024 Jan 4;8(1):pkad107. doi: 10.1093/jncics/pkad107.
PubMed 38113421
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy (BREVITY / BREVITY-02 in Germany)
- ClinicalTrials.gov ID
- NCT03524430
- Acronym / sponsor ID
- BREVITY / RnaDx-BRV-BC- 01
- Conditions
- Breast Neoplasm Female
- Keywords
- Breast cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 801 participants (estimated)
- Lead sponsor
- Rna Diagnostics Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 22 May 2031 (estimated)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 tumor response assessment tool that uses tumor 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 enroll approximately 801 patients in centers in the US, Canada, Italy, Germany, Spain and France and Poland.
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:
- 1st core needle biopsy for RDA (2 specimens): Time Point: 35 +/- days after initiation of neoadjuvant chemotherapy;
- 2nd core needle biopsy for RDA (2 specimens): Time Point: if therapy is changed (as part of SoC), a second biopsy ~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. If Therapy is not changed (as part of SoC), a second biopsy is taken at 55 +/- 5 days after the first initiation of neoadjuvant therapy.
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 enroll 801 patients in order to achieve an accrual of 534 fully evaluable patients (phase 1 and 2) which is the number required to adequately statistically power the trial. Recruitment per subgroup of cancer subtypes will be closed when the target number of fully evaluable patients per subgroup is reached for both phase 1 and 2. Combined statistical analysis and various subgroup analyses will be performed for the primary and secondary objectives.
Duration and Follow-up:
There will be an active patient accrual until last patient is accrued (to achieve the required fully evaluable patient numbers) in addition to 60 months of patient follow-up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Interventional Study Arm | Experimental | Procedure: Core needle biopsyThere 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core needle biopsy1st 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. | Procedure or surgery | Single Interventional Study Arm |
Primary outcome
Pathological complete response (pCR)
Time frame: At surgery after completion of neoadjuvant therapy
(ypT0,ypN0) / (ypTis,ypN0)
2 secondary outcomes
Disease-free survival
Time frame: 5 years of survival follow-up
Residual Cancer Burden
Time frame: At surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Background: PubMed 26208483Parissenti AM, Guo B, Pritzker LB, Pritzker KP, Wang X, Zhu M, Shepherd LE, Trudeau ME. Tumor RNA disruption predicts survival benefit from breast cancer chemotherapy. Breast Cancer Res Treat. 2015 Aug;153(1):135-44. doi: 10.1007/s10549-015-3498-9. Epub 2015 Jul 25.
- Background: PubMed 26911141Narendrula R, Mispel-Beyer K, Guo B, Parissenti AM, Pritzker LB, Pritzker K, Masilamani T, Wang X, Lanner C. RNA disruption is associated with response to multiple classes of chemotherapy drugs in tumor cell lines. BMC Cancer. 2016 Feb 24;16:146. doi: 10.1186/s12885-016-2197-1.
- Background: PubMed 27377904Toomey S, Eustace AJ, Pritzker LB, Pritzker KP, Fay J, O'Grady A, Cummins R, Grogan L, Kennedy J, O'Connor D, Young L, Kay EW, O'Donovan N, Gallagher WM, Kalachand R, Crown J, Hennessy BT. RE: RNA Disruption Assay as a Biomarker of Pathological Complete Response in Neoadjuvant Trastuzumab-Treated Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer. J Natl Cancer Inst. 2016 Jul 4;108(8):djw111. doi: 10.1093/jnci/djw111. Print 2016 Aug. No abstract available.
- Background: PubMed 26063893Pritzker K, Pritzker L, Generali D, Bottini A, Cappelletti MR, Guo B, Parissenti A, Trudeau M. RNA Disruption and Drug Response in Breast Cancer Primary Systemic Therapy. J Natl Cancer Inst Monogr. 2015 May;2015(51):76-80. doi: 10.1093/jncimonographs/lgv015.
- Results publication: PubMed 38113421Cazzaniga ME, Ademuyiwa F, Petit T, Tio J, Generali D, Ciruelos EM, Califaretti N, Poirier B, Ardizzoia A, Hoenig A, Lex B, Mouret-Reynier MA, Giesecke D, Isambert N, Masetti R, Pitre L, Wrobel D, Augereau P, Milani M, Rask S, Solbach C, Pritzker L, Noubir S, Parissenti A, Trudeau ME. Low RNA disruption during neoadjuvant chemotherapy predicts pathologic complete response absence in patients with breast cancer. JNCI Cancer Spectr. 2024 Jan 4;8(1):pkad107. doi: 10.1093/jncics/pkad107.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maureen Trudeau, MD principal investigator
Sunnybrook Health Sciences Center, Toronto, Canada
Daniele Generali, MD principal investigator
SST di Cremona Multidisciplinare di Patologia Mammaria, Italy
Foluso Ademuyiwa, MD principal investigator
Washington University School of Medicine, St Louis, USA
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core needle biopsy in people with Breast Neoplasm Female, run by Rna Diagnostics Inc. at 7 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada, France, Germany, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) (time frame: At surgery after completion of neoadjuvant therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03524430, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.