E-Newsletter - October 2015

Alliance Foundation Trials and Austrian Breast & Colorectal Cancer Study Group Open Largest Global Phase III Trial of Targeted Therapy for HR+/HER2- Early Breast Cancer

The Alliance Foundation Trials, LLC (AFT), the Austrian Breast & Colorectal Cancer Study Group (ABCSG), and Pfizer Inc. recently launched the Palbociclib Collaborative Adjuvant Study, or PALLAS. This global phase III 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. About 60 to 65 percent of breast cancers in the United States fall into this category.
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.
The PALLAS trial is a prospective, two-arm, international, multicenter, randomized, open-label phase III study. The trial is open to premenopausal and postmenopausal women or men with stage II or stage III 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.

Hats off to New Hampshire Oncology Hematology Associates (Douglas J. Weckstein, MD - Principal Investigator) -- the first Alliance network member to register a patient on this trial.  New Hampshire OHA was one of several sites selected to pariticipate in the PALLAS trial. The process of site selection for PALLAS is ongoing. Other sites are being contacted and invited to participate. To learn more about the PALLAS trial, visit https://clinicaltrials.gov/show/NCT02513394 or e-mail PALLAS_AFT@alliancefoundationtrials.org. Also, see the PALLAS press release.

About Alliance Foundation Trials, LLC (AFT)

Alliance Foundation Trials, LLC (AFT) is a research organization that develops and conducts cancer clinical trials, working closely with pharmaceutical partners, research collaborators and the Alliance for Clinical Trials in Oncology scientific investigators and institutional member network.  AFT seeks to fulfill the vision of the Alliance for Clinical Trials in Oncology to reduce the impact of cancer on people by uniting a broad community of scientists and clinicians from many disciplines committed to discovering, validating and disseminating effective strategies for the prevention and treatment of cancer.

Established in 2014 as a limited liability corporation, AFT is managed by the Alliance for Clinical Trials in Oncology Foundation, which is its sole member. The AFT operational structure and funding sources are separate from the Alliance clinical trials program funded by the National Cancer Institute (NCI).

The leadership of AFT includes Monica M. Bertagnolli, MD, Chief Executive Officer and Gini F. Fleming, MD, Chief Scientific Officer

Collaboration with AFT

AFT offers clinical trial investigators, pharmaceutical partners and the Alliance for Clinical Trials in Oncology institutional member network collaborative opportunities to develop and conduct trials, in addition to NCI-funded initiatives. This expands access and trial design options. AFT studies are developed by the Alliance scientific committees and are integrated into scientific goals of the committees.

Sites eligible to participate in AFT trials are members of the Alliance for Clinical Trials in Oncology network in good standing. AFT determines site-protocol matches based on previous site performance, accrual reports and results from its feasibility process. AFT invites sites that meet these criteria to participate in trials.

To learn more about AFT, visit www.alliancefoundationtrials.org.


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For other articles in the October issue of Alliance E-News, see below.