US-based drugmaker Pfizer, Alliance Foundation Trials (AFT) and Austrian Breast & Colorectal Cancer Study Group (ABCSG) have launched Phase III trial of Ibrance (palbociclib) for patients with hormone receptor-positive early breast cancer.
The Palbociclib Collaborative Adjuvant Study (PALLAS) will assess whether the addition of Ibrance, developed by Pfizer, to standard therapy will improve disease-free survival and prevent the disease from recurring.
The study for patients with early-stage breast cancer is being carried out in conjunction with Breast International Group (BIG), German Breast Group (GBG), National Surgical Adjuvant Breast and Bowel Project (NSABP), and PrECOG.
Patients enrolled in the study will have cancers that are hormone receptor-positive (HR+), whose growth is enhanced by the hormone estrogen, but are negative for human epidermal growth factor receptor 2 (HER2-), a different tumour-associated protein.
The PALLAS study is a prospective, two-arm, international, multicenter and randomised trial, which will enrol premenopausal and postmenopausal women, or men with stage two or stage three HR+ / HER2- early breast cancer.
In the trial, patients will be randomised to one of two treatment arms, of which one study arm will treat patients with Ibrance (at a dose of 125mg orally once daily for 21 days followed by seven days off treatment in a 28-day cycle) for two years and standard endocrine adjuvant therapy for at least five years.
The second study arm will treat patients with standard endocrine adjuvant therapy alone for at least five years. Around 4,600 subjects are expected to be enrolled in the trial worldwide.
In February this year, Ibrance received approval from the US Food and Drug Administration (FDA) to treat postmenopausal women with estrogen receptor-positive (ER+) / HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease.