c-TRAK TN: A randomised trial utilising ctDNA mutation tracking to detect minimal residual disease and trigger intervention in patients with moderate and high risk early stage triple negative breast cancer

Institute of Cancer Research0 sites208 target enrollmentJune 19, 2017

ConditionsBreast cancer Cancer

Overview

Phase: 未知
Intervention: Not specified
Conditions: Breast cancer
Sponsor: Institute of Cancer Research
Enrollment: 208
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36423745/ (added 04/01/2023)

Registry

who.int

Start Date

June 19, 2017

End Date

March 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Institute of Cancer Research

Eligibility Criteria

Inclusion Criteria

•Current inclusion criteria as of 31/10/2019:
•1\. Signed Informed Consent Form for Registration
•2\. Male or female patients ages 16 years or older
•3\. ECOG performance status 0, 1 or 2
•4\. Histologically proven primary triple negative breast cancer as defined as oestrogen receptor (ER) negative, progesterone receptor (PgR) negative (if available, otherwise PgR unknown), (as defined by Allred score 0/8 or 2/8 or stain in \<1% of cancer cells) and HER2 negative (immunohistochemistry 0/1\+ or negative by in situ hybridization) as determined by local laboratory
•5\. Availability of tissue from two archival tumour tissue samples (either from diagnostic biopsy, and/or primary surgery). If only one tumour sample is available, the site should inform the ICR\-CTSU who will discuss eligibility with the Chief Investigator (or designated TMG member). Patients who have tumours previously sequenced outside the c\-TRAK TN trial must provide one archival tumour tissue sample and the report that confirms the mutations detected
•6\. Patients with moderate or high\-risk early\-stage triple\-negative breast cancer according to the following risk of relapse criteria:
•6\.1\. Neoadjuvant chemotherapy (no adjuvant chemotherapy planned):
•6\.1\.1\. High\-risk criteria \- Residual microscopic or macroscopic invasive cancer in the axillary nodes after chemotherapy
•6\.1\.2\. Moderate risk criteria \- Residual invasive cancer in the breast, and axillary lymph node negative after chemotherapy

Exclusion Criteria

•Current exclusion criteria as of 26/10/2018:
•1\. Any concurrent or planned treatment for the current diagnosis of breast cancer other than surgery, locoregional adjuvant radiotherapy, standard adjuvant chemotherapy, or a bisphosphonate/denosumab
•2\. Prior treatment with a PDL1, PD1, or other immunomodulatory therapy
•3\. Prior diagnosis of cancer including prior diagnosis of breast cancer in the previous 5 years, other than for basal cell carcinoma of the skin or cervical carcinoma in situ
•4\. Patients previously entered into a therapeutic trial during or after neoadjuvant chemotherapy where experimental therapy is continued post\-surgery
•5\. Treatment with an unlicensed or investigational product within 4 weeks of trial entry
•6\. Active autoimmune disease requiring systemic therapy in the last two years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of such systemic treatment
•7\. Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab
•8\. Known history of active TB (Tuberculosis Bacillus)
•9\. Known history of Human Immunodeficiency Virus (HIV)