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PATRICIA trial results published in the Clinical Cancer Research journal

PATRICIA trial results published in the Clinical Cancer Research journal

16 Sep 2020

Palbociclib shown to be effective in patients with HER2-positive advanced breast cancer

• The Clinical Cancer Research journal, which makes part of American Association for Cancer Research (AACR) publishes the results of the SOLTI-1303 PATRICIA study for patients with metastatic breast cancer previously treated with multiple treatments.

• It is the first study to show, prospectively, the benefit of treatment with palbociclib and trastuzumab in patients with HER2-positive breast cancer.

• The results suggest that a treatment without chemotherapy would be an alternative for these patients.

• The intrinsic subtype obtained by the PAM50 test would be a useful biomarker to predict the benefit of combined palbociclib + trastuzumab therapy and hormonal treatment.

Barcelona, September 16th 2020

The journal Clinical Cancer Research publishes today the results of the first phase of the PATRICIA clinical study for the treatment of previously treated locally advanced or metastatic HER2-positive breast cancer, led by SOLTI, an academic and translational clinical research group in oncology.

Preliminary results presented at the San Antonio Breast Cancer Symposium are now confirmed with the publication of this manuscript. The PATRICIA trial evaluates the efficacy of the combination of palbociclib (a CDK4/6 inhibitor) + trastuzumab (an anti-HER2 therapy) and hormonal therapy in patients with HER2-positive breast cancer with or without hormone receptors in metastatic breast cancer as well as the impact of this treatment on progression-free survival (PFS) of these patients.

The results show that the study drug combination is safe and that, thanks to it, the patients of the luminal subtype (classified according to the PAM50 test), which represents around 40% of the patients tested, significantly improved the progression free survival (PFS) period. For this reason, the researchers point out that the luminal subtype by PAM50 would be a potential biomarker that must be confirmed in future clinical studies.

Another additional advantage of these results, according to Dr. Eva Ciruelos, SOLTI’s co-Chair and Principal Investigator of the study, Coordinator of the Multidisciplinary Breast Cancer Unit of the Hospital Universitario 12 de Octubre in Madrid, is that “it is a scheme without chemotherapy , which would be the treatment of choice in these patients, and so this alternative can significantly contribute to reducing adverse events and therefore improving their quality of life. "

Finally, given that the subgroup of luminal patients according to the PAM50 test obtains a greater benefit from this triple combination of drugs, the researchers will initiate another study, PATRICIA II, which will be the continuation and aims to previously select patients based on this biomarker. Dr. Aleix Prat, SOLTI’s Chair, Principal Translational Researcher of the study and Head of Medical Oncology at Hospital Clínic de Barcelona, ​​adds: “This is the first study in the world to prospectively use the molecular classification by PAM50 to select what patients with advanced HER2 + disease can enter the study ”.

Palbociclib, the drug under evaluation in this trial, added to trastuzumab, is developed by the company Pfizer Inc. and is a CDK4 / 6 inhibitor, a therapeutic strategy in which great research efforts are currently being made due to its role in the control of the cell cycle and the results of the PATRICIA trial may have implication in the development of other clinical trials currently underway with this drug.

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