Triple Negative breast cancer Trial (TNT)

Disease site: Breast Cancer

Treatment Modality: Chemotherapy

Status: Open to recruitment

TNT is a randomised phase III trial of carboplatin compared to docetaxel for patients with metastatic or recurrent locally advanced ER-, PR- and HER2- or known BRCA1 or BRCA 2 mutation associated breast cancer.

Approximately 15-25% of breast cancers have an ER, PR and HER2 negative (Triple Negative) phenotype.  This equates to approximately 8000 - 11000 new “Triple Negative” cases per year in the UK. Data suggest there may be particular enrichment in premenopausal women and women from ethnic minorities in urban areas of the UK.

There is a need for a proof of principle/translational research study to both test current and define new biology driven therapy hypotheses within the “Triple Negative” sub-type.  TNT has been developed to achieve these aims by determining whether there is greater activity for carboplatin than a taxane standard of care (docetaxel) in women with ER-, PR- and HER2- or BRCA1 or BRCA2 mutation associated breast cancer and facilitating translational research to optimise existing chemotherapeutics and find new targets for therapy in this breast cancer sub-types.

TNT is co-ordinated by the ICR - Clinical Trials & Statistics Unit and is supported by the NCRI Breast Clinical Studies Group.  Approximately 370-450 patients will be randomised.  

The trial opened to recruitment in January 2008 and is actively recruiting new centres.

Chief Investigator: Dr Andrew Tutt, Consultant Oncologist, Guy’s Hospital Breast Unit/ Director Breakthrough Breast Cancer Research Unit, King’s College London

Sponsor: The Institute of Cancer Research and King's College Hospital London

Source of funding: Cancer Research UK and Breakthrough Breast Cancer

ISRCTN: 97330959