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

Tumor RNA Disruption Assay as a Tool to Predict Response to Neoadjuvant Chemotherapy in Breast Cancer: Optimizing Timing of Biopsy

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.

Study Overview

• Status: Completed
• Conditions: Invasive Breast Cancer
• Intervention / Treatment: Device: Tumor RDA biopsy

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathologic complete response (pCR).	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.	At time of surgery (4-8 months after first dose of neoadjuvant therapy).

Collaborators and Investigators

• Sponsor: Jewish General Hospital
• Collaborators: Laurentian University
• Investigators: Principal Investigator: Jean-Francois Boileau, MD MSc FRCSC, McGill University, Montreal, Quebec, Canada

Publications and helpful links

General Publications

• Parissenti AM, Chapman JA, Kahn HJ, Guo B, Han L, O'Brien P, Clemons MP, Jong R, Dent R, Fitzgerald B, Pritchard KI, Shepherd LE, Trudeau ME. Association of low tumor RNA integrity with response to chemotherapy in breast cancer patients. Breast Cancer Res Treat. 2010 Jan;119(2):347-56. doi: 10.1007/s10549-009-0531-x.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: July 10, 2014
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (Estimate): July 15, 2014

Study Record Updates

• Last Update Posted (Estimate): February 4, 2015
• Last Update Submitted That Met QC Criteria: February 2, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Breast Cancer; Chemotherapy; Response; Neoadjuvant; RNA Disruption Assay; Biopsies
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: MJGH-RDA