Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy

• ClinicalTrials.gov Identifier: NCT03709134
• Recruitment Status: Unknown
• First Posted: October 17, 2018
• Last Update Posted: October 14, 2021
• Sponsor: Sunnybrook Health Sciences Centre
• Information provided by (Responsible Party): Dr. Katarzyna Jerzak, Sunnybrook Health Sciences Centre

Tracking Information

• First Submitted Date: October 12, 2018
• First Posted Date: October 17, 2018
• Last Update Posted Date: October 14, 2021
• Actual Study Start Date: October 1, 2019
• Estimated Primary Completion Date: September 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 15, 2018)

Pathologic complete response (pCR) [ Time Frame: Up to 60 months ]

Evaluating the degree of absence of residual cancer cells

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 6, 2020)

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

Original Secondary Outcome Measures (submitted: October 15, 2018)

• 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.
• Time to distant metastasis [ Time Frame: Up to 60 months ]
  Evaluating onset of distant metastasis
• Time to death [ Time Frame: Up to 60 months ]
  Evaluating time to cancer-related death

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy
• Official Title: Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy
• 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.
• 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.
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years

Biospecimen

Retention:   Samples With DNA

Description:

Blood samples

• 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.

Condition

• Breast Cancer
• Breast Neoplasms
• Cancer, Breast

Intervention

Diagnostic Test: Genomic Markers (CTC/ctDNA)

This is a non-interventional study.

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 15, 2018): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 1, 2022
• Estimated Primary Completion Date: September 1, 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03709134
• Other Study ID Numbers: 178-2018
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Dr. Katarzyna Jerzak, Sunnybrook Health Sciences Centre
• Original Responsible Party: Dr. William Tran, Sunnybrook Health Sciences Centre, Radiation Therapist Clinician Scientist
• Current Study Sponsor: Sunnybrook Health Sciences Centre
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Katarzyna J Jerzak, MD, MSc, FRCPC; Sunnybrook Health Sciences Centre

• PRS Account: Sunnybrook Health Sciences Centre
• Verification Date: October 2021