NCT02239315

Brief Summary

The purpose of this study is to find out if the pathological complete response (pCR) to chemotherapy given before surgery (neoadjuvant chemotherapy) could be predicted by the evaluation of the RNA (ribonucleic acids) disruption pattern (RNA Disruption Assay or RDA score) obtained from a biopsy of the tumor 7 - 14 days after the first, second and third cycles of chemotherapy treatment. If we can determine the optimal time during neoadjuvant chemotherapy to measure the RDA score for the prediction of pCR, we can optimize breast cancer management.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

4 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

September 2, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

1.4 years

First QC Date

September 2, 2014

Last Update Submit

October 25, 2017

Conditions

Breast Neoplasms

Keywords

Breast cancersNeoadjuvant chemotherapyRNA Disruption Assay™ (RDA) scorePathological Complete Response (pCR)Fine Needle Aspiration Biopsy

Outcome Measures

Primary Outcomes (1)

  • The association between RDA score and pathological complete response (pCR)

    The association between tumor RDA score measured 7-14 days after the first, second and third cycles of chemotherapy and the pCR to neoadjuvant chemotherapy will be evaluated. pCR is defined as no evidence of invasive carcinoma in the breast and lymph nodes (ypT0/Tis ypN0/N0itc) on histology at the time of surgery (lumpectomy or mastectomy).

    An expected average of 6 months

Secondary Outcomes (5)

  • The prognostic ability of RDA score

    An expected average of 6 months

  • The association between RDA score and clinical response (cR)

    An expected average of 6 months

  • Patients' perception of fine needle aspiration biopsy (FNAB) and of breast cancer care

    An expected average of 12 months

  • The cost-effectiveness of using RDA score

    An expected average of 6 months

  • The association between RDA score and Disease-Free Survival (DFS)

    An expected average of 5 years

Study Arms (1)

Tumor RNA Disruption Assay™ (RDA)

EXPERIMENTAL

Tumor RNA Disruption Assay™ (RDA) to generate RDA score from fine needle aspiration biopsy samples of breast cancer obtained 7-14 days after the first, second and third cycles of neoadjuvant chemotherapy; and, if there is a change of chemotherapy regimen, after the first cycle of the new chemotherapy.

Other: Tumor RNA Disruption Assay™ (RDA)

Interventions

Tumor RNA Disruption Assay™ (RDA)OTHER

Tumor RNA Disruption Assay™ (RDA) to generate RDA score from fine needle aspiration biopsy samples of breast cancer obtained 7-14 days after the first, second and third cycles of neoadjuvant chemotherapy; and, if there is a change of chemotherapy regimen, after the first cycle of the new chemotherapy.

Also known as: Biomarker
Tumor RNA Disruption Assay™ (RDA)

Eligibility Criteria

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

You may qualify if:

  • Female,18 years or older;
  • Able to read and write in English:
  • With palpable cancer \> 2cm (T2, T3) on clinical examination or clinical diagnosis of locally advanced breast cancer (LABC) (T3 or T4; or N2 or N3, according to TNM cancer staging including inflammatory breast cancer);
  • Must have histological proof of breast cancer (invasive ductal or infiltrating lobular);
  • Scheduled to receive neoadjuvant chemotherapy as part of their treatment plan;
  • Agree to have FNAB after the first, second and third cycle of chemotherapy, and if the chemotherapy regimen is changed, an additional FNAB after the first cycle of the new chemotherapy.

You may not qualify if:

  • Subjects who have had surgery, neoadjuvant chemotherapy or radiotherapy for the current breast cancer;
  • Subjects who are pregnant or breast feeding;
  • Subjects with Stage IV breast cancer;
  • Psychiatric or addictive disorders that may limit the ability to give informed consent or complete the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hamilton Health Sciences Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

Sunnybrook Health Sciences Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (3)

  • 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

  • Schroeder A, Mueller O, Stocker S, Salowsky R, Leiber M, Gassmann M, Lightfoot S, Menzel W, Granzow M, Ragg T. The RIN: an RNA integrity number for assigning integrity values to RNA measurements. BMC Mol Biol. 2006 Jan 31;7:3. doi: 10.1186/1471-2199-7-3.

    PMID: 16448564BACKGROUND

  • Guidance for Industry- Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval (May 2012). US DHHS FDA CDER; Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM305501.pdf

    BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

  • Murray Krahn, MD,MSc,FRCPC

    Director of THETA Collaborative, the F. Norman Hughes Chair in Pharmacoeconomics and Social and Administrative Pharmacy Division Head in the Faculty of Pharmacy, Professor at the University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc, FRCPC

Study Record Dates

First Submitted

September 2, 2014

First Posted

September 12, 2014

Study Start

December 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

CA(4)