This is a randomized, open label, Phase III Trial to evaluate the efficacy and safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy after induction treatment for Hormone Receptor Positive (HR+)/HER2-Positive metastatic breast cancer.
This study is open to people diagnosed with hormone receptor (HR) positive, Human Epidermal Growth Factor Receptor 2 (HER-2) positive metastatic breast cancer. Despite significant improvements in the treatment of early-stage breast cancer, approximately 30% of women experience metastatic disease relapse. Development of therapies targeting the HER2 receptor has dramatically improved patient outcomes.
The PATINA study aims to find out if people with metastatic breast cancer could benefit from the addition of a new drug, Palbociclib, when given in combination with anti-HER2 therapy (trastuzumab and pertuzumab) and endocrine therapy. Trastuzumab and pertuzumab are designed to target HER-2 and block its role in tumour cell growth and survival. They are currently used for the first line treatment of metastatic HER-2 positive breast cancer together with a class of chemotherapy called taxanes. Endocrine treatment is standard of care for the treatment of HR positive breast cancer. Endocrine treatment prevents breast cancer cell growth by blocking the action of hormone receptors. After a period of treatment with all three drugs at the same time (also called “induction therapy”), the pertuzumab and trastuzumab therapy may be continued without chemotherapy.
The PATINA clinical trial will investigate if the addition of palbociclib to first-line treatment of HER-2 positive breast cancer will delay the onset of therapeutic resistance and prolong survival, as well as finding out more about the side effects, safety and effectiveness of the drug combination.
PATINA is an international clinical trial and will be managed by Breast Cancer Trials in partnership with Alliance Foundation Trials (AFT). In New Zealand it will be open at Auckland City Hospital. If you think you might be eligible for this trial please consult your doctor or medical team about it.
For more information visit https://www.breastcancertrials.org.au/current-clinical-trials/patina