Puma Biotechnology has hit its goal in terms of how many people it has signed up for a Phase III test of PB272 (neratinib) to fight breast cancer.
The people who will take part in this test are battling HER2-positive breast cancer that has spread and who have taken two or more drug treatments that were unsuccessful.
Those who will take part in the study will take either PB272 and Xeloda or Tykerb and Xeloda. There is no predetermined plan to decide who will take the PB272 and Xeloda and who will take the Tykerb and Xeloda, according to a company press release. Almost 600 people are signed up to take the test.
The researchers' main analysis of the outcomes of this test will be how many people beat the cancer and how many people survive even if the cancer does get worse.
Puma Biotechnology and the U.S. Food and Drug Administration have partnered to put together the Phase III test as a special protocol assessment. The European Medicines Agency has also given Puma biotechnology tips on both the test setup and the major analysis areas.
The testing will take place in North America, Europe and the Asia-Pacific region.