Status:
COMPLETED
RNA Disruption Assay (RDA) Response Prediction in Neoadjuvant Chemotherapy Breast Cancer Treatment
Lead Sponsor:
Jewish General Hospital
Collaborating Sponsors:
Laurentian University
Conditions:
Invasive Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the optimal time to use the Tumor RNA Disruption Assay (RDA) as a predictor of pathological complete response (pCR) in patients with breast cancer treated wit...
Detailed Description
This prospective clinical trial will determine if the tumor RDA score can predict for pCR after the first, second, and third cycles of chemotherapy in women with breast cancer treated with neoadjuvant...
Eligibility Criteria
Inclusion
- Patients must be female.
- Patients must be 18 years of age or older.
- Patients with stage I, II, or III breast cancer that is greater or equal to 2 cm on clinical examination.
- Patients that have biopsy proven invasive breast cancer diagnosed by core needle biopsy
- Patients who are chemotherapy and radiotherapy naïve for the treatment of the current breast cancer.
- Patients that accept to undergo neoadjuvant chemotherapy.
- Patients with bilateral breast cancer are eligible.
- Patients that understand, accept, and have signed the approved written consent form.
- Patients will need to consent to be part of the study.
Exclusion
- Patients with one or more of the following conditions are ineligible for this study:
- Patients who have had previous surgery, chemotherapy or radiotherapy for the current breast cancer
- Patients who are pregnant or breast feeding.
- Psychiatric or addictive disorders or conditions or social factors that may preclude the patient from meeting study requirements.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02190227
Start Date
May 1 2013
End Date
September 1 2014
Last Update
February 4 2015
Active Locations (1)
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1
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2