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ABSTRACT
Introduction
Triple negative breast cancer (TNBC) was once thought to be an insurmountable disease marked by a lack of targeted treatments. However, we are now witnessing the dawn of targeted therapies for TNBC in which progress has stemmed from an improved understanding of the components that make TNBC unique. The identification of biomarkers, such as BRCA1/2, PIK3CA and RSK2, have advanced the field remarkably and there is considerable interest in finding novel therapeutics for TNBC that offer durable clinical benefit with fewer adverse events.
Areas covered
We discuss phase I/II trials of new and emerging targeted therapies for TNBC, according to ClinicalTrials.gov up to June 2020. Although the emphasis is on ongoing and completed early phase trials, we also highlight pivotal studies that have led to the approval of new targeted classes of drugs for TNBC, with a focus on outcomes and common adverse events of each class of therapy.
Expert opinion
The way forward for TNBC treatment is through precision medicine. The use of novel agents matched with biomarkers to identify patients with the best chance of sustainable response offers new hope. We now have great potential for improving the outcomes for patients with TNBC.
Acknowledgement
We thank Dr Nick Sharp for his constructive criticism of the drafts and his suggestions that substantially improved the manuscript.
Article highlights
Triple negative breast cancer (TNBC) has the worst prognosis of all the breast cancer subtypes; it is histologically defined as lacking estrogen and progesterone receptors (ER/PR) and human epidermal growth factor receptor 2 (HER2) amplification. TNBC is further divided into subtypes which respond differently to treatment; however, the clinical significance of these differences has not yielded definitive therapeutic benefits.
Despite approved novel therapeutics, metastatic triple negative breast cancer (mTNBC) remains an aggressive heterogeneous disease that devastates lives.
Antibody-drug conjugates (ADCs), immuno-oncology (I/O) therapies, and poly (ADP-ribose) polymerase (PARP) inhibitors have joined the armamentarium against specific types of TNBC but have limited durable efficacy in patients.
Emerging targeted therapies in phase I/II have shown promise primarily in combination with standard of care and as single agents. Treatment sequence and timing is critical to maximize the effect of combination therapies and requires an understanding of unique tumor characteristics and signaling pathways.
Precision medicine is being further established with biomarkers, which decipher how to match patient populations to their optimal treatment regimen.
Selected kinase inhibitors are the next likely class of novel targeted therapy to enter the TNBC treatment armamentarium.
This box summarizes key points contained in the article.
Declaration of interest
M Huynh, MR Pambid, A Jayanthan and SE Dunn are employed by Phoenix Molecular Designs. A Dorr is contracted to Phoenix Molecular Designs as CMO. G Los is contracted to Phoenix Molecular Designs as CSO. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewer disclosures
One reviewer has advisory roles in and has received research grants and speaker fees from Roche, Lilly, Amgen, EISAI, BMS, Pfizer, Novartis, MSD, Genomic Health, Ipsen, AstraZeneca, Bayer, Leo Pharma, Merck, Daiichi, and Seattle Genetics. Peer reviewers on this manuscript have no other relevant financial or other relationships to disclose