Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Recruiting
CT.gov ID
NCT03709134
Collaborator
(none)
100
1
35
2.9

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy
Actual Study Start Date :
Oct 1, 2019
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Pathologic complete response (pCR) [Up to 60 months]

    Evaluating the degree of absence of residual cancer cells

Secondary Outcome Measures

  1. Time to distant breast cancer recurrence (months) [Up to 60 months]

    Evaluating the time until a recurrence event has occurred in the breast.

  2. Time to any recurrence (months) [Up to 60 months]

    Evaluating the time until a local, regional, or distant recurrence event has occurred.

  3. Time to death [Up to 60 months]

    Evaluating time to cancer-related death

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5

Sponsors and Collaborators

  • Sunnybrook Health Sciences Centre

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Oct 17, 2018
Last Update Posted:
Oct 14, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Katarzyna Jerzak, Medical Oncologist & Associate Scientist, Sunnybrook Health Sciences Centre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2021