Rethinking clinical trial design: maximizing the results from each clinical trial participant

Breast cancer remains the most common cancer diagnosed in women. Triple negative breast cancers (TNBC) especially remain difficult to treat with poorer prognosis than hormone receptor and HER2-neu positive tumors. Although relatively responsive to neoadjuvant chemotherapy with pathological complete response (pCR) of up to 50%, for those who don’t achieve a pCR the outcome is poor (1). The hallmark of TNBC is the development of chemoresistant metastatic disease, with the highest frequency of metastases in the first 1–2 years after completing chemotherapy, a rate 2–3 times higher than non-TNBC subtypes (2). The median overall survival for women with metastatic TNBC remains a dismal 12 months, with worse outcomes in patients with CNS metastases (3). As such, the need for developing new therapies TNBC is particularly pressing.