As a leader in precision oncology, we are constantly expanding innovation with challenging new studies and prestigious collaborations. We drive further research in the clinical applications of genomics and champion the value of Big Data.
These are just some of the clinical trials that we’re involved with right now.
We’re proud to be part of the groundbreaking I-SPY2 trial, which looks at whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR)* over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry.
So far, findings support the use of residual cancer burden (RCB)† as a prognostic indicator for 3-year outcomes in patients pre-selected as high risk for recurrence, and the importance of MammaPrint in identifying these patients.
A next-gen adaptive platform
I-SPY2 breaks from the traditional randomized form of trial, employing an ‘adaptive’ model that allows multiple treatments (up to six different agents) to be studied in parallel. This master framework also allows new agents to enter and leave the study without having to halt enrollment or resubmit the entire clinical trial protocol for regulatory review.
I-SPY2’s innovative design sets a new benchmark for efficiency in phase II clinical trials, by minimizing the number of participants and time required to evaluate each experimental agent. Widely regarded as a pioneer of the ‘platform’ trial, I-SPY2 is a major influence on the development of next-generation trial designs in oncology and beyond.
We have launched a new ten-year clinical trial for patients in the US, known as the FLEX Study.
FLEX is a large-scale, prospective, observational breast cancer study that links full genome profiling, including MammaPrint and BluePrint, with complete clinical data. FLEX creates a comprehensive patient database with the potential to identify new gene associations with prognostic and/or predictive value in breast cancer.
Our first milestone is to capture genomic and clinical data for 10,000 breast cancer patients and follow them over 10 years.
Open to both women and men diagnosed with stage I, II, or III cancer, including all molecular subtypes, the dataset will be a true representation of the entire patient population. By capturing data from all ethnicities, ages, genders, and from patients with co-morbidities, the FLEX database provides valuable opportunities to accelerate breast cancer research.
FLEX will enable researchers to investigate the differences and trends between breast cancer sub-groups. Importantly, it also allows a focus on smaller, more diverse, patient populations which have traditionally been challenging to recruit in sufficient numbers for clinical trials.
“FLEX has the potential to become one of the most valuable and impactful national datasets in breast cancer research–a veritable \’Google\’ for combined clinical and genomic breast cancer information.”
—Joyce O’Shaughnessy, MD
Chair of the Breast Cancer Program for US Oncology Research, Texas Oncology and Celebrating Women Chair in Breast Cancer Research at Baylor University Medical Center, Dalls, TX
Where to next?
*Pathological complete response (pCR) predicts event-free survival (EFS)‡ and distant recurrence–free survival (DRFS) in the setting of a multiple agent platform trial and enables rapid evaluation of novel therapy combinations and can accelerate the identification of effective and potentially less toxic regimens.
†Residual cancer burden is how much cancer is left after neoadjuvant treatment. Characteristics such as the tumor’s size, histological features, and number of positive lymph nodes are used to determine the residual cancer burden.
‡After primary treatment for a cancer ends, event-free survival (EFS) is achieved when the patient remains free of certain complications or events that the treatment was originally intended to prevent or delay.