The positive three-year follow-up results of the PHERGain clinical trial, sponsored by MEDSIR, demonstrating that one-third of patients with localized HER2-positive breast cancer can be cured without the need for chemotherapy, have been published in the prestigious scientific journal The Lancet.
PHERGain is the first study with a strategic design that allows tailoring therapy for each patient based on the initial treatment response and complete pathological response.
Results indicate that 94.8% of all patients who followed this adaptive treatment strategy remain free from recurrence of their cancer after 3 years of follow-up
New Jersey, April 4th, 2024 - The PHERGain clinical trial, developed by MEDSIR - a company dedicated to promoting independent clinical research in oncology internationally - has been published in the prestigious journal The Lancet, following positive results showing that one-third of patients with localized HER2-positive breast cancer can be cured without requiring chemotherapy, drastically reducing side effects.
This study marks a milestone by using an adaptive design to personalize treatment in the neoadjuvant/adjuvant setting for patients with localized HER2-positive breast cancer. The main goal was to evaluate the feasibility of an adaptive therapeutic strategy based initially on exclusive treatment with dual HER2 blockade using trastuzumab and pertuzumab, with the addition of chemotherapy based on early response observed by PET-CT and complete pathological response.
The trial was led by MEDSIR researchers Dr. Javier Cortés, Dr. Antonio Llombart-Cussac, and Dr. José Pérez. "The results of this study bring us closer to the end of chemotherapy in a significant percentage of patients with this type of tumor," says Dr. Javier Cortés, the principal investigator of the study.
The initial results of the PHERGain clinical trial showed that early assessment of response to exclusive preoperative treatment without chemotherapy based on trastuzumab and pertuzumab, using PET-CT, could identify around 40% of patients with localized HER2-positive breast cancer who achieved a complete pathological response. These positive results were published in the journal Lancet Oncology in 2021.
Results from the second primary objective, which aimed to analyze invasive disease-free survival at three years in all patients who followed this adaptive treatment strategy, were initially presented in Chicago during the annual meeting of the American Society of Clinical Oncology (ASCO) in June 2023 and have now been published in The Lancet.
According to the PHERGain study, 30% of patients with localized HER2-positive breast cancer could forego chemotherapy while maintaining excellent survival. Additionally, patients who eventually had to receive chemotherapy due to an insufficient response did not compromise their prognosis.
The study results demonstrate that 94.8% of all patients who followed this adaptive therapeutic strategy, regardless of whether they received chemotherapy or not, remain cancer-free three years after surgical intervention following treatment. This percentage is even higher (96.4%) in patients who did not have to receive chemotherapy. The study involved researchers from 45 centers in 7 European countries and included 356 patients with localized HER2-positive breast cancer.
The obtained results have been considered extraordinarily relevant and represent a new therapeutic option to be carefully considered in routine clinical practice, as they show that many patients can be treated safely and effectively without chemotherapy without compromising their prognosis. Additionally, it highlights the importance and benefit of adaptive clinical trials, focused on individualized patient care, compared to classic designs that pit two already closed treatment options against each other.
This is the first study that gradually adjusts the treatment for each patient based on their response to therapy, moving towards more personalized medicine, which was achieved with the global participation of academic and clinical collaborators, whose contribution has been significant in this clinical trial.
About MEDSIR
Founded in 2012, MEDSIR works closely with its partners to drive innovation in oncology research. Based in Spain and the United States, the company manages all aspects of clinical trials, from study design to publication, utilizing a global network of experts and integrated technology to streamline the process.
The company offers proof-of-concept support and a strategic approach that helps research partners experience the best of both worlds from industry-based clinical research and investigator-driven trials. To promote independent cancer research worldwide, MEDSIR has a strategic alliance with Oncoclínicas, the leading oncology group in Brazil with the greatest research potential in South America. Learn how MEDSIR brings ideas to life: www.medsir.org
About Dr. Javier Cortés
Dr. Javier Cortés is the Senior Scientific Leader of MEDSIR and co-founder. He is also the Head at the International Breast Cancer Center (IBCC) Scientific director of the IOB Institute of Oncology in Madrid, Director of the Breast Cancer Program at the Beata María Ana Hospital in Madrid and professor at the European University of Madrid.
About Dr. Antonio Llombart-Cussac
Dr. Antonio Llombart-Cussac is the Senior Scientific Leader of MEDSIR and co-founder. He is also the Head of the Medical Oncology Department at Arnau de Vilanova Hospital in Valencia.
About Dr. José Pérez
Dr. José Pérez is MEDSIR Medical Associate and Deputy Director of the International Breast Cancer Center (IBCC).
