Status:
TERMINATED
Study of Tumor RNA Disruption Assay™ (RDA)
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
University Health Network, Toronto
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to find out if the pathological complete response (pCR) to chemotherapy given before surgery (neoadjuvant chemotherapy) could be predicted by the evaluation of the RNA (ri...
Detailed Description
When administering neoadjuvant chemotherapy, the current practice of monitoring response to treatment is by measuring the size of the breast tumor after each cycle of chemotherapy. The drawback to thi...
Eligibility Criteria
Inclusion
- Female,18 years or older;
- Able to read and write in English:
- With palpable cancer \> 2cm (T2, T3) on clinical examination or clinical diagnosis of locally advanced breast cancer (LABC) (T3 or T4; or N2 or N3, according to TNM cancer staging including inflammatory breast cancer);
- Must have histological proof of breast cancer (invasive ductal or infiltrating lobular);
- Scheduled to receive neoadjuvant chemotherapy as part of their treatment plan;
- Agree to have FNAB after the first, second and third cycle of chemotherapy, and if the chemotherapy regimen is changed, an additional FNAB after the first cycle of the new chemotherapy.
Exclusion
- Subjects who have had surgery, neoadjuvant chemotherapy or radiotherapy for the current breast cancer;
- Subjects who are pregnant or breast feeding;
- Subjects with Stage IV breast cancer;
- Psychiatric or addictive disorders that may limit the ability to give informed consent or complete the trial.
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT02239315
Start Date
December 1 2015
End Date
May 1 2017
Last Update
October 26 2017
Active Locations (4)
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1
Hamilton Health Sciences Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
2
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
3
Sunnybrook Health Sciences Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
4
St Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8