RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy
RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy (BREVITY / BREVITY-02 in Germany)
Rna Diagnostics Inc.
801 participants
Apr 26, 2018
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria10
- 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;
Interventions
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.
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT03524430