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

  • STATUS
    Recruiting
  • End date
    Oct 26, 2025
  • participants needed
    594
  • sponsor
    Rna Diagnostics Inc.
Updated on 28 May 2021
cancer
breast cancer
adjuvant therapy
invasive breast cancer

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.

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 and DFS (secondary endpoint) 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, Ireland 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:

  • 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 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.

Details
Condition Breast Neoplasm Female
Treatment core needle biopsy
Clinical Study IdentifierNCT03524430
SponsorRna Diagnostics Inc.
Last Modified on28 May 2021

Eligibility

Yes No Not Sure

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
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