Key Projects


 

APHINITY is a large, randomised phase III, double-blind, placebo-controlled study that compares the efficacy and safety of chemotherapy plus trastuzumab and placebo with that of chemotherapy plus trastuzumab and pertuzumab as adjuvant therapy in approximately 4800 patients with operable, HER2-positive, primary breast cancer. Pertuzumab and trastuzumab are two drugs that target and block the HER2 protein on the cancer cells.

Several recent studies have shown that dual inhibition of the HER2 receptor with two drugs is clinically more effective than using a single agent. APHINITY is testing this hypothesis, to find out if the combination of pertuzumab and trastuzumab is better than trastuzumab alone, in terms of efficacy, for patients who have had surgery for HER2 positive breast cancer. The study aims also at exploring the safety of the combination, by looking at the potential side effects on treated patients.

See global press release on primary endpoint results at: http://www.roche.com/media/store/releases/med-cor-2017-03-02.htm


 

 

Frontier Science has collaborated on the HERA trial, an adjuvant trial comparing observation vs one year of Herceptin® vs two years of Herceptin® in women with early stage HER2 positive breast cancer. The study was funded by Roche. FSS has worked with the Breast International Group (BIG) and the Coordinating Group BrEAST on many aspects of trial management for HERA, on data quality control and on the statistical analysis of the data.  The first results of the study were published in the New England Journal of Medicine in October 2005. The results of 2 years Herceptin vs 1 year Herceptin were published in the Lancet in July 2013. Manuscripts on cardiac safety and from several research projects have been published. Further publications are currently in preparation.


Frontier Science is collaborating with the Breast International Group (BIG) on the ALTTO and neo-ALTTO trials. These trials are built on the results from the successful HERA trial and compare Herceptin® with a new drug lapatinib, both as single agents and in combination and sequence. Frontier Science is responsible for randomisation, various aspects of project management, data quality control and for statistical programming and analysis. This trial involves participation of breast cancer trials groups and independent sites around the world, including North America. The North American participation in the trial is co-ordinated by the ALLIANCE (formerly North Central Cancer Treatment Group (NCCTG)).


OlympiA is a randomized, double-blind, parallel group, placebo-controlled multi-center Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy. This international study is sponsored by AstraZeneca and the US National Cancer Institute (NCI) and is coordinated by the Breast International Group (BIG). Frontier Science provides project management; statistical leadership, design and analysis; randomization; data management; and programming. A separate firewalled Frontier Science statistical unit provides independent statistical analysis for the Data Monitoring


FINESSE is a clinical trial partnership between Frontier Science, Breast International Group (BIG), Breast European Adjuvant Study Team (BrEAST) and in collaboration with Institut de Recherches Internationales SERVIER. It is an open, 3-cohort, phase II trial testing oral administration of lucitanib in patients with FGFR1 ER+ metastatic breast cancer.

It is a global trial involving about 20 sites -being initiated at this moment- from France, Spain, Italy, Germany, UK, Belgium, Canada and Australia, with a target accrual of 2-4 patients per site.

The trial is ongoing. Frontier Science provide continuous safety and efficacy reports to all committees charged with oversight of the trial, including international regulatory committees.


The EPoS study is a group of related randomised controlled clinical trials which aim to address the optimum colonoscopy surveillance interval for patients who have had premalignant polyps identified and removed from the large bowel, in order to determine the most effective surveillance programme for the prevention of colorectal cancer. 27,500 participants from a selection of European countries are assigned to one of three EPoS trials depending on the characteristics of their presenting polyps (categorised as high risk, low risk or serrated polyps), following a clinical colonoscopy. In collaboration with the University of Oslo, Frontier Science designed the randomisation method, developed the eCRF data collection system, and is responsible for ongoing clinical database management, data management and reporting.


NoTOPain is a randomised, crossover, placebo controlled, double-blind, Phase II study of cetuximab in patients with treatment-refractory, non-malignant severe chronic neuropathic pain.  Neuropathic pain is a subtype of pain that can be caused by a variety of pathological processes that directly affect the sensory nervous system.

The trial is a proof of concept study with a single study site at the Sørlandet Sykehus, Kristiansand hospital in Norway. The Kristiansand hospital fulfils the dual role of Sponsor and Investigator Site for this study. Frontier Science is undertaking a wide scope of work for this study including randomisation; data management; collaboration in protocol development; statistical design, analysis and reporting and trial monitoring.


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Colorectal cancer (CRC) is major burden in western countries which develops over a long time-interval from precursor lesions which exist in the colon. Colonoscopy can detect and remove the precursor lesions and may therefore be an effective intervention for the prevention of CRC. The NordICC study is a randomised controlled trial which compares a study group, who are offered a one-time screening colonoscopy, with a control group who follow the current standard of care. The aim of the study is to address the efficacy of population colonoscopy screening on reducing CRC incidence and mortality after 15 years of follow up. Frontier Science collaborates with the University of Oslo to manage the data collection and cleaning processes, and clinical database management for the study, which has over 100,000 participants from Norway, Poland, Netherlands and Sweden.