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

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 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;

Conditions3

Locations1 site

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