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Study of Tumor RNA Disruption Assay™ (RDA) (RnaDx)

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ClinicalTrials.gov Identifier: NCT02239315
Recruitment Status : Terminated (Lack of funding)
First Posted : September 12, 2014
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Murray Krahn, University of Toronto

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Other: Tumor RNA Disruption Assay™ (RDA) Not Applicable

Detailed Description:

When administering neoadjuvant chemotherapy, the current practice of monitoring response to treatment is by measuring the size of the breast tumor after each cycle of chemotherapy. The drawback to this method is, it will take several weeks before we can actually measure a significant change in size; and the initial response to chemotherapy is often evident as a softening of the tumor without an apparent decrease of the tumor size. Finding a reliable way to identify early response to chemotherapy would be helpful to enable matching of chemotherapy to an individual's need.

In a previous trial of breast cancer treated with neoadjuvant chemotherapy, researchers have identified that the pCR to a full treatment of chemotherapy could be predicted by the change in RNA pattern obtained from a biopsy of the tumor half way through the chemotherapy course. [Parissenti et al. 2010] The purpose of this study is to determine if we can predict the pCR to neoadjuvant chemotherapy by examining the pattern of RNA disruption (RNA Disruption Assay or RDA score) from breast biopsy tissue obtained 7 to 14 days after the first, second and third cycle of chemotherapy. 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. For example, if RDA score can identify non-responders earlier, we can switch to other chemotherapy agents and reduce the exposure to the unnecessary side-effects of ineffective treatment.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of Tumor RNA Disruption Assay™ (RDA) and Its Association With a Response to Neoadjuvant Chemotherapy in Breast Cancer - A Prospective Mixed-Methods Study
Study Start Date : December 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Tumor RNA Disruption Assay™ (RDA)
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)
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 Name: Biomarker




Primary Outcome Measures :
  1. The association between RDA score and pathological complete response (pCR) [ Time Frame: An expected average of 6 months ]
    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).


Secondary Outcome Measures :
  1. The prognostic ability of RDA score [ Time Frame: An expected average of 6 months ]
    The capacity of RDA score to predict pCR to neoadjuvant chemotherapy will be assessed by exploring for a cut point on the RDA score to differentiate subjects with a high likelihood of achieving pCR versus those who are less likely to achieve pCR.

  2. The association between RDA score and clinical response (cR) [ Time Frame: An expected average of 6 months ]
    The association between tumor RDA score measured 7-14 days after the first, second and third cycles of chemotherapy and clinical response to neoadjuvant chemotherapy treatment will be evaluated.

  3. Patients' perception of fine needle aspiration biopsy (FNAB) and of breast cancer care [ Time Frame: An expected average of 12 months ]
    We shall seek to understand the experiences of patients with the FNAB procedure and with the cancer care they received while participating in the study by conducting qualitative interviews of study subjects.

  4. The cost-effectiveness of using RDA score [ Time Frame: An expected average of 6 months ]
    The cost-effectiveness of using RDA score to guide neoadjuvant chemotherapy will be evaluated by measuring the cost-effectiveness of monitoring pCR to neoadjuvant chemotherapy through the RDA score and in modifying the neoadjuvant chemotherapy regimen for non-pCR patients accordingly.

  5. The association between RDA score and Disease-Free Survival (DFS) [ Time Frame: An expected average of 5 years ]
    The association between tumor RDA score measured 7-14 days after the first, second and third cycles of chemotherapy and DFS will be evaluated. DFS will be measured as the time from patient's enrollment to the event of cancer metastasis or recurrence, or death, whatever comes first.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239315


Locations
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Canada, Ontario
Hamilton Health Sciences Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
Sunnybrook Health Sciences Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
St Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
University of Toronto
University Health Network, Toronto
Investigators
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Principal Investigator: 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

Publications:
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Responsible Party: Murray Krahn, MD, MSc, FRCPC, University of Toronto
ClinicalTrials.gov Identifier: NCT02239315     History of Changes
Other Study ID Numbers: 495462
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by Murray Krahn, University of Toronto:
Breast cancers
Neoadjuvant chemotherapy
RNA Disruption Assay™ (RDA) score
Pathological Complete Response (pCR)
Fine Needle Aspiration Biopsy

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases