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Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03709134
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Katarzyna Jerzak, Sunnybrook Health Sciences Centre

Brief Summary:
The primary aim of the study is to identify genomic markers (circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), transcriptomic markers) as biomarkers of response to neoadjuvant chemotherapy (NAC) among patients with invasive breast cancer.

Condition or disease Intervention/treatment
Breast Cancer Breast Neoplasms Cancer, Breast Diagnostic Test: Genomic Markers (CTC/ctDNA)

Detailed Description:
The study aims to evaluate genetic markers (i.e. CTCs and ctDNA) in breast tumors to predict therapy response and metastatic risk. We aim to investigate genomic markers of treatment response and outcomes in breast cancer patients treated with neoadjuvant chemotherapy. The role of CTCs and ctDNA in predicting response to NAC will also be investigated.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Intervention Details:
  • Diagnostic Test: Genomic Markers (CTC/ctDNA)
    This is a non-interventional study.


Primary Outcome Measures :
  1. Pathologic complete response (pCR) [ Time Frame: Up to 60 months ]
    Evaluating the degree of absence of residual cancer cells


Secondary Outcome Measures :
  1. Time to distant breast cancer recurrence (months) [ Time Frame: Up to 60 months ]
    Evaluating the time until a recurrence event has occurred in the breast.

  2. Time to any recurrence (months) [ Time Frame: Up to 60 months ]
    Evaluating the time until a local, regional, or distant recurrence event has occurred.

  3. Time to death [ Time Frame: Up to 60 months ]
    Evaluating time to cancer-related death


Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study will enroll women and men with a pathologically-confirmed diagnosis of invasive breast cancer that is stage I-III according to the AJCC v7 criteria.
Criteria

Inclusion Criteria:

  1. Subjects must give appropriate written informed consent prior to participation in the study.
  2. Subjects must be women or men age 18+.
  3. Subjects must be receiving neoadjuvant chemotherapy for breast cancer. All chemotherapy types and regimens are acceptable (systemic therapy will determined by the overseeing medical oncologist).
  4. Biopsy-confirmed diagnosis of invasive breast cancer (i.e. ER+/-, PR+/-, HER2+/-).
  5. Stage I-III disease according to the AJCC v7 criteria.

Exclusion Criteria:

  1. Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g. silicone/saline implants) involving either breast, exclusive of the lesion at issue.
  2. Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study, such as significant anxiety.

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): NCT03709134


Contacts
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Contact: Katarzyna J Jerzak, MD, MSc, FRCPC 416-480-6100 ext 5248 katarzyna.jerzak@sunnybrook.ca
Contact: William T Tran, MSc, PhD, MRT(T) 416-480-6100 ext 3746 william.tran@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Katarzyna J Jerzak, MD, MSc, FRCPC    416-480-6100 ext 5248    katarzyna.jerzak@sunnybrook.ca   
Contact: William T Tran, MSc, PhD, MRT(T)    416-480-6100 ext 3746    william.tran@sunnybrook.ca   
Principal Investigator: Kasia J Jerzak, MD, MSc         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Katarzyna J Jerzak, MD, MSc, FRCPC Sunnybrook Health Sciences Centre
Additional Information:

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Responsible Party: Dr. Katarzyna Jerzak, Medical Oncologist & Associate Scientist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03709134    
Other Study ID Numbers: 178-2018
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Katarzyna Jerzak, Sunnybrook Health Sciences Centre:
Circulating tumor cells
CTC
Circulating tumor DNA
ctDNA
Genomics
Transcriptomics
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases