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RNA Disruption Assay (RDA) Response Prediction in Neoadjuvant Chemotherapy Breast Cancer Treatment

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Laurentian University
Information provided by (Responsible Party):
Jean-Fancois Boileau, Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT02190227
First received: July 10, 2014
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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 with neoadjuvant chemotherapy.

This is important because the earlier non-responders are identified, the greater is the impact of reducing side effects of ineffective treatments.

The study hypothesis is that the RDA score will accurately predict for tumor response after one cycle of chemotherapy.


Condition Intervention Phase
Invasive Breast Cancer
Device: Tumor RDA biopsy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Tumor RNA Disruption Assay as a Tool to Predict Response to Neoadjuvant Chemotherapy in Breast Cancer: Optimizing Timing of Biopsy

Resource links provided by NLM:


Further study details as provided by Jewish General Hospital:

Primary Outcome Measures:
  • Pathologic complete response (pCR). [ Time Frame: At time of surgery (4-8 months after first dose of neoadjuvant therapy). ] [ Designated as safety issue: No ]
    Determine the optimal time at which Tumor RNA Disruption Assay (RDA) can predict pathological complete response (pCR) in patients with breast cancer treated with neoadjuvant chemotherapy.


Enrollment: 30
Study Start Date: May 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tumor RDA biopsy
Tumor RDA score measured from an FNA biopsy after cycle 1-2-3 of neoadjuvant chemotherapy and after first cycle of second chemotherapy agent if palpable tumour present.
Device: Tumor RDA biopsy
Tumor RDA score measured from an FNA biopsy after cycle 1-2-3 of neoadjuvant chemotherapy and after first cycle of second chemotherapy agent if palpable tumour present.

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 therapy. Tumor RDA score will also be measured after the first dose of any new chemotherapy agent if residual palpable disease is present.

Data will be collected until accrual target of 30 patients is met. All patients will undergo core needle biopsy of the breast tumor and analysis of ER, PR, and HER-2-Neu receptors. Patients will receive neoadjuvant therapy as recommended by their treating physicians. All chemotherapy regimens will be acceptable for participation in this study. Usually, these regimens are between 6 to 8 cycles, often with a switch of chemotherapy regimens after 3 to 4 cycles.

Evaluation of tumor size will be determined by 2 axis tumor measurement performed prior to, and after each chemotherapy treatment. The Tumor RDA score will be evaluated by performing fine needle aspiration (FNA) biopsies under local anesthetic, if the tumor is clinically palpable, after the first, second, and third cycles of chemotherapy. Tumor RDA score will also be determined if palpable tumor is present after the first cycle of any second chemotherapy agent.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02190227

Locations
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Jewish General Hospital
Laurentian University
Investigators
Principal Investigator: Jean-Francois Boileau, MD MSc FRCSC McGill University, Montreal, Quebec, Canada
  More Information

Publications:
Responsible Party: Jean-Fancois Boileau, Surgical Oncologist and Clinician-Researcher, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT02190227     History of Changes
Other Study ID Numbers: MJGH-RDA
Study First Received: July 10, 2014
Last Updated: July 11, 2014
Health Authority: Canada: Institutional Review Board

Keywords provided by Jewish General Hospital:
Breast Cancer
Chemotherapy
Neoadjuvant
RNA Disruption Assay
Biopsies
Response

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 27, 2014