PATINA Trial Design Summary
The PATINA trial is a pivotal, open-label, international, phase III study aimed at evaluating the efficacy and safety of palbociclib in combination with anti-HER2 therapy (tx) and endocrine therapy (ET) for HR+/HER2+ metastatic breast cancer (MBC). The trial includes patients with histologically confirmed HR+/HER2+ MBC who have no evidence of disease progression following 4-8 cycles of chemotherapy (taxane or vinorelbine) combined with anti-HER2 tx.
Patients will be randomized 1:1 to receive standard anti-HER2 tx (trastuzumab +/- pertuzumab) in combination with ET, with or without palbociclib, until disease progression. ET options include an aromatase inhibitor or fulvestrant, with premenopausal women receiving an LHRH agonist. The trial plans to enroll 496 patients.
The primary objective is to demonstrate that the combination of palbociclib with anti-HER2 tx plus ET is superior to anti-HER2 tx plus ET alone in prolonging progression-free survival (PFS). Key secondary objectives include tumor control, overall survival, safety, and quality of life. A main translational science objective is to compare PFS based on PIK3CA mutation status.
Patients participating in PATINA will be asked to share remaining biospecimens with the Mastering Breast Cancer Initiative, which aims to understand the natural history of MBC and develop new treatments. Recruitment began in July 2017 and is ongoing across approximately 130 sites in Australia, Germany, Italy, New Zealand, Spain, and the US.
About the Study Author – Sibylle Loibl
Prof. Dr. Sibylle Loibl is the Chair of the German Breast Group and the CEO of GBG Forschungs GmbH. She is an associate professor of obstetrics and gynaecology at the Goethe University of Frankfurt. She obtained her doctorate from Ruprecht Karl University of Heidelberg and trained as a consultant in gynaecology and obstetrics at the women’s clinics of the university hospitals in Heidelberg and Frankfurt am Main.
Prof. Dr. Loibl is internationally renowned for her research in neoadjuvant breast cancer, breast cancer during pregnancy, and breast cancer in young women. She established the Translational Research Group within the German Breast Group and has led numerous major research projects. She has conducted and managed several national and international practice-changing clinical trials.
She has authored over 400 original and peer-reviewed articles, scientific papers, and written books and chapters. Prof. Dr. Loibl is an active member of prestigious organizations such as ASCO, ESMO, DKG, and AGO. She has contributed to national and international breast cancer guidelines, including those from ESMO and ASCO. Additionally, she was the first Co-Chair of the ESMO Breast Conference in Berlin and is an active faculty member of major conferences like ASCO, ESMO, and SABCS.
“Late Breaking: In PATINA trial, patients with HR-positive, HER2-positive metastatic breast cancer had improved progression-free survival when palbociclib was added to endocrine and anti-HER2 therapy, says Otto Metzger, MD at SABCS24.”
“PATINA—the addition of palbociclib to HP after discontinuation of docetaxel in 1L mHER2+BC—results in an improvement in median PFS from 29.1 months to 44.3 months, a HR 0.74.”
“Amazingly presented by Otto Metzger at SABCS24:
The PATINA Phase III trial testing Palbociclib + Anti-HER2 Therapy + ET vs. Anti-HER2 Therapy + ET in 1st-line HER2+ breast cancer maintenance.
PFS: 29.1 vs. 44.3 months with Palbo (52-month follow-up).
OS: Immature.”
“Very promising data from PATINA trial presented at SABCS24 by Otto Metzger showing the value of maintenance therapy with Endocrine Therapy + palbociclib + dual anti-HER2 therapy in patients with HER2+ advanced Breast Cancer after induction with CT.”
“At SABCS24 GS2 potentially practice changing results of PATINA, phase III trial testing Palbociclib + Anti-HER2 Therapy + ET vs. Anti-HER2 Therapy + ET after Induction Treatment in 1st line
Significant improvement in PFS in the palbociclib arm
OS immature.”
“Otto Metzger presents PATINA.
Maintenance ET + HP +/- Palbo in 1st line HER2+ maintenance.
PFS: 29.1 vs. 44.3 months with Palbo with 52-month follow-up.
OS not significant yet.
Low counts, fatigue, and stomatitis were the most common AEs, with only 7% of patients discontinuing treatment.”
“PATINA at SABCS2024
Patients have gotten through a tough chemo, if you add something toxic to their subsequent therapy, it should increase OS!
We NEED to stop saying toxicities are ‘manageable’, the palbo group had much more toxicities, it should be said like that, without spin.”
