The huge global study, ABCSG 42/PALLAS, is presently investigating whether or not a drug (palbociclib) that is already displaying fine promise as remedy for metastasised breast cancer might also be highly successful in the treatment of the most common form of breast cancer: early-stage hormone-receptor-positive, HER2-negative breast cancer.
This study is being performed in the United States and in different nations such as Austria, Australia, Belgium and Spain. The lead investigator for all international locations outside USA is Michael Gnant, Head of the Breast Health Center at MedUni Vienna and Vienna General Hospital, Deputy Head of the Comprehensive Cancer Center (CCC) Vienna and President of the Austrian Breast & Colorectal Cancer Study Group (ABCSG). Over the next two years, as much as 500 patients from Austria can also be included within the study.
Breast Cancer Study
In Austria, there are around 5,200 new instances of breast cancer each year. The majority of these are women however some males are additionally affected. Around 75% of newly diagnosed breast cancers are of the hormone-receptor-positive type, that is to say their development is encouraged by the release of sex hormones.
In a large-scale worldwide study, ABCSG 42/PALLAS, researchers at the moment are investigating whether or not typical endocrine healing, in the form of a therapy that inhibits the creation of these hormones, may also be increased by the administration of the drug palbociclib. Palbociclib is a kinase inhibitor drug, an active agent that inhibits cell development and the division of cancer cells.
Michael Gnant, the head of this study outside US remarked, “Palbociclib has already been licensed to treat metastasised breast cancer, where it is proving to be very successful. The drug has the potential to revolutionise the treatment of early-stage, hormone-receptor-positive breast cancer. Our aim is to extend progression-free survival and, in the long term, to achieve a permanent cure in the majority of patients.”
Internationally, it’s anticipated that 4,600 sufferers from 25 countries can be incorporated in this largest ever worldwide phase-III trial for patients with hormone-receptor-positive, early-stage breast cancer. Roughly half of those are being recruited in the US. Gnant remarked, “Since the principal investigator is based here in Austria, with the focal point at the Comprehensive Cancer Center (CCC) of MedUni Vienna and Vienna General Hospital, we might manage to include up to 500 Austrian patients in the study, thereby giving them access to this new therapy.”
The ABCSG 42/PALLAS Study
The ABCSG 42/PALLAS study compares disease-free survival with typical endocrine therapy (at a minimum of 5 years) plus the drug palbociclib (2 years) in opposition to standard endocrine remedy alone (at least 5 years) in female and male breast cancer sufferers with ER-positive and HER-negative breast cancer and risk of recurrence Stage II or III. It’s taking position in an adjuvant setting, that’s to claim that all subjects have already had the tumour surgically removed.
Outside the United States, the study is currently being carried out in Austria, Australia, Belgium and Spain, with new trial centres joining always. For example, the Ethics Committee has already given an optimistic vote for Hungary. The recruiting phase must be completed by 2018; 309 sufferers have already been recruited global, eighty one of these from Austria.
The worldwide undertaking is being carried out alongside Alliance Foundation Trials (AFT), the Breast International Group (BIG) the German Breast Group (GBG), the National Surgical Adjuvant Breast and Bowel Project (NSABP), PrECOG from the Eastern Cooperative Oncology Group and Pfizer as industrial partner.