The Ramón y Cajal University Hospital and its Health Research Institute IRYCIS are participating in a clinical trial that seeks to find out if a new therapeutic strategy without chemotherapy could be as effective and less toxic than current standard treatment in patients with HER-2 positive breast cancer.
The purpose of PHERGain-II clinical trial is aligned with one of the great priorities in oncology research according to the criteria of reference associations such as the American Society of Clinical Oncology (DISGUST): that clinical research
oncology prioritize the reduction of toxicity associated with cancer treatment.
“Considering the side effects and impact of chemotherapy on the quality of life of patients with early breast cancer, it is important to study therapeutic de-escalation strategies that allow traditional systemic chemotherapy to be dispensed with in correctly selected patient profiles”, explained Alfonso Cortesprincipal investigator of the clinical trial at Hospital Ramón y Cajal/IRYCIS.
On the other hand, Cortés warns that “currently, the treatment in these cases continues to be the chemotherapy along with drugs aimed at blocking the HER-2 proteinprecisely this study seeks to know if the new strategy has the same efficacy”.
“This study is being carried out in a very selected profile of patients, it would not be extended to all patients with HER-2 breast cancer” he adds.
He also explained that “we still have to wait for the results of the study but if they are positive we could avoid chemotherapy in some patients with localized HER2-positive tumors.
About the Phergain-II clinical trial
HER-2+ breast cancer is a type of cancer with high presence of human epidemic growth factor receptor 2 (HER-2), a protein that promotes the growth of cancer cells. When these tumors are found early – before they spread to other areas of the body – they usually are treated with chemotherapy and therapies aimed at blocking HER-2 and then operate. Even in those patients with a better prognosis, the combination with chemotherapy remains part of the standard treatment for prevent tumor recurrence after surgery. For these patients, there is great interest in exploring an optimized combination or sequence with HER2-targeted drugs that eeliminates the need for chemotherapy without affecting the benefit of treatmentwhich could have a positive impact on the quality of life of patients.
In the PHERGain-II trial, patients will be given preoperative treatment with trastuzumab and pertuzumab, drugs aimed at blocking HER-2, without chemotherapy. In addition, the tumors will be monitored by magnetic resonance imaging before and after treatment. After surgery, based on response to trastuzumab and pertuzumab therapy, continue treatment with the same combination of drugs or with T-DM1 (another HER-2 blocking drug), reserving the use of chemotherapy only for those patients who have responded worse to preoperative treatment and therefore have a worse prognosis.
In addition, the researchers will conduct a three-year follow-up to these patients to know their evolution and detect if the relapse rate is equivalent to that obtained through the use of chemotherapy.
Representation of hospitals in the Community of Madrid
In addition to the Ramón y Cajal, the Clinical Hospital and the Torrejón Hospital participate in this multicentre and international study, forming part of a total of 70 hospitals in Spain, France, Germany, the United Kingdom and Italy.
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