Palbociclib + Endocrine Therapy for Breast Cancer
(PALLAS Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot take medications that strongly affect CYP3A enzymes within 7 days before starting the trial. You also cannot be on antiretroviral therapy or other investigational drugs.
What data supports the effectiveness of the drug Palbociclib when used with endocrine therapy for breast cancer?
Research shows that adding Palbociclib to endocrine therapy improves progression-free survival (the time during which the cancer does not get worse) in patients with hormone-receptor-positive, HER2-negative metastatic breast cancer. This suggests that Palbociclib can enhance the effectiveness of endocrine therapy in treating certain types of breast cancer.12345
Is Palbociclib combined with endocrine therapy safe for humans?
Palbociclib combined with endocrine therapy has been generally well-tolerated in studies, though common side effects include low white blood cell counts (neutropenia and leukopenia) and mouth sores (stomatitis). Serious side effects like fever with low white blood cell count (febrile neutropenia) were rare, and overall, patients did not experience a significant decline in quality of life.56789
How is the drug palbociclib plus endocrine therapy unique for breast cancer treatment?
Palbociclib plus endocrine therapy is unique because it combines a cyclin-dependent kinase 4/6 inhibitor with hormone therapy, which helps to significantly prolong progression-free survival in patients with hormone receptor-positive, HER2-negative advanced breast cancer compared to hormone therapy alone.3781011
What is the purpose of this trial?
This trial is testing whether adding the drug palbociclib to standard hormone therapy can improve treatment for patients with a specific type of early breast cancer. The targeted patients have hormone receptor-positive and HER2-negative breast cancer. Palbociclib works by blocking proteins that help cancer cells grow, potentially making the hormone therapy more effective.
Research Team
Erica L. Mayer, MD MPH
Principal Investigator
Dana-Farber Cancer Institute
Angela DeMichele, MD
Principal Investigator
University of Pennsylvania
Evanthia Galanis, MD
Principal Investigator
Alliance Foundation Trials, LLC.
Michael Gnant, MD
Principal Investigator
ABCSG, Medical University Vienna
Eligibility Criteria
This trial is for adults over 18 with HR+/HER2- early breast cancer (Stage II or III), who have had surgery, can take oral meds, and are on or starting hormone treatment. They must not be pregnant, have normal organ function tests, no history of other cancers, and no severe illnesses that could affect participation.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive palbociclib in addition to standard adjuvant endocrine therapy for 2 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Palbociclib
- Standard Adjuvant Endocrine Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance Foundation Trials, LLC.
Lead Sponsor
Austrian Breast & Colorectal Cancer Study Group
Collaborator
NSABP Foundation Inc
Collaborator
PrECOG, LLC.
Collaborator
Breast International Group
Collaborator
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University