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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Invasive Breast Cancer

Intervention / Treatment
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* Device: Tumor RDA biopsy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tumor RDA biopsy<br>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<br>* 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.<br>|

What is the study measuring?
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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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Chemotherapy, Neoadjuvant, RNA Disruption Assay, Biopsies, Response