c-TRAK TN: A clinical 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 - c-TRAK T

The Institute of Cancer Research0 sites150 target enrollmentMay 22, 2017

Overview

No summary available.

Registry

who.int

Start Date

May 22, 2017

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Inclusion criteria for all patients:
•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 the 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:
•Neoadjuvant chemotherapy (no adjuvant chemotherapy planned):
•High risk criteria \- Residual microscopic or macroscopic invasive cancer in the axillary nodes after chemotherapy
•Moderate risk criteria \- Residual invasive cancer in the breast, and axillary lymph node negative after chemotherapy

•Exclusion criteria for all patients:
•1\. Any concurrent or planned treatment for the current diagnosis of breast cancer other than surgery, locoregional adjuvant radiotherapy, standard neoadjuvant or 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 Tuberculosis Bacillus (TB).
•9\. Known history of Human Immunodeficiency Virus (HIV).