Dutch test maker Agendia and its nonprofit research partners said this week that they have completed patient recruitment for a trial that will determine whether the company's array-based MammaPrint test is better than standard criteria in selecting breast cancer patients for adjuvant chemotherapy.
The company's research partners for the 6,000-patient Microarray in Node Negative and 1-3 Positive Lymph Node Disease, or MINDACT, trial are the European Organization for Research and Treatment of Cancer and the Breast International Group.
Agendia CEO Bernhard Sixt said in a statement that the completion of patient recruitment is a "major milestone" for the trial.
"If MammaPrint is ultimately shown to predict individual patient response to the trial-specific cancer therapies currently on the market, it will likely create significant and valuable synergies for the manufacturers of these drugs by improving treatment success rates," Sixt said.
He also said that information from the trial could be used to generate "new specific companion diagnostics" that can be added to the company's offering.
More than 6,600 patients in 111 institutions across nine countries were enrolled from February 2007 to July 2011 to take part in MINDACT, the partners said. MINDACT is investigating the clinical value of Agendia's MammaPrint test as compared to standard clinicopathological criteria for the selection of breast cancer patients for adjuvant chemotherapy.
The study aims to provide further evidence that breast cancer patients with low recurrence risk as determined by MammaPrint may not need chemotherapy. "This would spare patients from burdensome side effects without increasing the risk of metastasis or reducing survival," the partners said.
Additionally, the study is designed to show whether MammaPrint can predict patient response to specific therapies.
Agendia's MammaPrint test uses an expression signature from 70 genes to help physicians decide whether breast cancer is likely to recur. The US Food and Drug Administration cleared the test in 2007. Agendia has offered its assay as a service via its labs in Amsterdam and Irvine, Calif.
MINDACT is a multi-center, prospective, phase III randomized study comparing Agendia's MammaPrint with "Adjuvant! Online," a clinical-pathological prognostic tool to select patients with negative or 1-3 positive nodes for adjuvant chemotherapy in breast cancer. Novartis, Roche, and Sanofi-Aventis are all funding the MINDACT trial.
The test is also being evaluated in the US National Cancer Institute-sponsored I-SPY II (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis) study, which is designed to predict therapeutic response in the neoadjuvant setting. Researchers in that trial are using Agendia's whole-genome microarray platform to develop oncologic therapies paired with biomarkers. Abbott, Amgen, Pfizer, J&J, Roche, and Eli Lilly are all participating in the trial.
Details about when the study would be completed were not discussed.
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