NCT02190227

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

1.3 years

First QC Date

July 10, 2014

Last Update Submit

February 2, 2015

Conditions

Invasive Breast Cancer

Keywords

Breast CancerChemotherapyNeoadjuvantRNA Disruption AssayBiopsiesResponse

Outcome Measures

Primary Outcomes (1)

  • 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).

Study Arms (1)

Tumor RDA biopsy

OTHER

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

Interventions

Tumor RDA biopsyDEVICE

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.

Tumor RDA biopsy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related 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.

    PMID: 19771508BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jean-Francois Boileau, MD MSc FRCSC

    McGill University, Montreal, Quebec, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgical Oncologist and Clinician-Researcher

Study Record Dates

First Submitted

July 10, 2014

First Posted

July 15, 2014

Study Start

May 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations

CA(1)