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

Invasive Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190227
• Other study ID #: MJGH-RDA
• Status: Completed
• Phase: Phase 2
• First received: July 10, 2014
• Last updated: February 2, 2015
• Start date: May 2013
• Est. completion date: September 2014

Study information

• Verified date: February 2015
• Source: Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Neoplasms
• Invasive Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Jewish General Hospital	Laurentian University

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No