Trial details

Trial short name: BREVITY

Official title: RNA Disruption Assay (RDA) - Breast cancer Response EValuation for Individualized TherapY

Principal Investigator: Dr. Andrea Eisen

Cancer type: Breast
Cancer location: Breast
Disease stage: Early and Advanced Cancer
Trial phase: Other
Intervention: Procedure: Core Needle Biopsy

Registration #: NCT03524430

Contact name: Tammy Taite

Contact phone: (416) 480-5000 x7934

Trial description:
The purpose of this study is to validate the results of an RNA Disruption Assay (RDA) as a cancer response assessment tool in patients with breast cancer. All patients participating in this study will have a core needle biopsy performed at 2-3 weeks after the initiation of chemotherapy or at other relevant time points.

Inclusion Criteria: • Must be 18 years of age or older; • Willing and able to provide informed consent to participate in the RDA study; • Newly diagnosed clinical stage II or III breast cancer with complete surgical excision of the breast cancer after neoadjuvant therapy as the treatment goal (stage I included in participating German sites); • Tumour size at least 1 cm in one dimension by clinical or radiographic exam (WHO criteria). Tumour size requirement differs by country in compliance with local standard of care and the approved local protocol; • Must have histological confirmation of invasive breast cancer of any subtype or grade; • Patient is scheduled for neoadjuvant chemotherapy +/- antibodies by the multidisciplinary tumour board of the center; • Patient willing to take a research core needle biopsy after the first cycle of chemotherapy - if the chemotherapy drugs will be changed as part of the planned treatment, patient agrees that a second biopsy will be taken after the first cycle of the new chemotherapy. 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; • Concurrent treatment with other experimental drugs and/or participation in another interventional clinical trial ; • Stage I or IV breast cancer (Stage I not excluded in participating German sites); • 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.