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OpenTrials
Completed

NCT Number: NCT03709134

Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cancer, Breast Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must give appropriate written informed consent prior to participation in the study.
  • Subjects must be women or men age 18+.
  • 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).
  • Biopsy-confirmed diagnosis of invasive breast cancer (i.e. ER+/-, PR+/-, HER2+/-).
  • Stage I-III disease according to the AJCC v7 criteria.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Genomic Markers (CTC/ctDNA)

Diagnostic Test

This is a non-interventional study.

Primary outcomes

  1. Pathologic complete response (pCR)

    Time frame: Up to 60 months

    Evaluating the degree of absence of residual cancer cells

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 17, 2018
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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