Date: 2015-08-26
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Alliance Foundation Trials (USA) Pfizer (USA - NY)
Product: Ibrance® (palbociclib)
Action
mechanism: cyclin dependant kinase inhibitor. Palbociclib is an investigational oral targeted agent that selectively inhibits cyclin-dependent kinases (CDKs) 4 and 6 to regain cell cycle control and block tumor cell proliferation. Ibrance® was approved in February 2015 by the FDA for the treatment of postmenopausal women with estrogen receptor-positive (ER+)/HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease. A hallmark of cancer cell growth is loss of control of the cell cycle, leading to unregulated growth and spread of cancer. A promising strategy to overcome this process involves inhibition of enzymes called cyclin-dependent kinases (CDKs), which allows re-establishment of control of cell growth. Recent research has shown that two related enzymes – CDK 4 and CDK 6 – are among the primary proteins that accelerate cancer cell growth, and may be particularly important in HR+ breast tumors. Research also indicates that combining CDK 4/6 inhibitors with endocrine therapy is beneficial in patients with advanced breast cancer. The new oral, anti-cancer drug IBRANCE blocks CDK 4/6.
Disease: breast cancer
Therapeutic area: Cancer - Oncology
Country:
Trial
details: PALLAS study is is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC). The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned. (NCT02513394)
Latest
news: * On August 26, 2015, The Alliance Foundation Trials, the Austrian Breast & Colorectal Cancer Study Group (ABCSG) and Pfizer announced the launch of the Palbociclib Collaborative Adjuvant Study, or PALLAS. This global Phase 3 clinical trial for patients with early-stage breast cancer is being conducted in conjunction with Breast International Group (BIG), German Breast Group (GBG), National Surgical Adjuvant Breast and Bowel Project (NSABP) and PrECOG, LLC (PrECOG). The PALLAS trial will evaluate whether the addition of Ibrance® (palbociclib), developed by Pfizer, to standard therapy will improve disease-free survival and prevent the disease from recurring. Patients treated in this study will have cancers that are hormone receptor-positive (HR+), meaning their growth is fueled by the hormone estrogen, but are negative for human epidermal growth factor receptor 2 (HER2-), a different tumor-associated protein. The PALLAS trial is a prospective, two-arm, international, multicenter, randomized, open-label Phase 3 study. The trial is open to premenopausal and postmenopausal women or men with stage 2 or stage 3 HR+/HER2- early breast cancer. Participants will be randomized (selected by chance) to one of two treatment arms. One study arm will treat patients with IBRANCE (at a dose of 125 mg orally once daily, day 1 to day 21 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 other study arm will treat patients with standard endocrine adjuvant therapy alone for at least five years. Participants will be recruited worldwide. Approximately 4,600 people are expected to enroll in the trial. The scope of the PALLAS trial is global. AFT and the ABCSG have brought together a collaborative group of breast cancer specialists from around the world to team up with Pfizer to form a unique public-private cancer research partnership aimed at bringing more innovative therapies to patients in more efficient ways. Currently, the new study is open to physicians and medical facilities throughout the U.S. if they are associated with Alliance, NSABP or PrECOG. The study will be available to non-U.S. sites beginning in October through an extended academic core network, including the ABCSG and BIG. Pfizer, the manufacturer of Ibrance®, is providing AFT and ABCSG with funding support for this trial. AFT is sponsoring the trial in the U.S. and ABCSG for all non-U.S. sites.
