Medsir, a global company dedicated to clinical research in oncology, presents the continuation of the PHERGain-II clinical trial to demonstrate that, in patients with HER2-positive early breast cancer and good prognosis, a therapeutic approach without chemotherapy may be as effective as the current standard of care, which involves the…
Medsir, a global company dedicated to clinical research in oncology, presents the continuation of the PHERGain-II clinical trial demonstrate that, in patients with early HER2-positive breast cancer with a good prognosis, a treatment approach without chemotherapy can be as effective as the current standard of care, which involves the use of this generally more toxic treatment.
The purpose of PHERGain-II falls within one of the major priorities of research against cancer according to the criteria of reference associations such as the American Society of Clinical Oncology (ASCO): that clinical research in oncology provides the priority to reducing the toxicity associated with cancer treatment.
“Given the side effects and the impact of chemotherapy on the quality of life of patients with early breast cancer, it is necessary to find a new therapeutic strategy to overcome traditional systemic chemotherapy in patients may achieve a similar response with less toxic treatment“, explained the Dr. José Ángel García Sáenz, lead researcher of the study at Clínico San Carlos Hospital.
HER-2+ breast cancer is a type of cancer with a strong presence of human epidemic growth factor receptor 2 (HER-2), a protein that promotes the growth of cancer cells. When these tumors are detected early, before they spread to other parts of the body, they are removed with surgery and treated with therapies aimed at blocking HER-2. However, even in patients with a good prognosis, the combination with chemotherapy remains part of the reference treatment to prevent tumor recurrence after surgery.
For these patients, there is great interest in exploring an optimized combination or sequence withn HER2-targeting drugs which eliminates the need for chemotherapy without affecting the clinical benefit of the treatment, which could have a positive impact on your quality of life.
In the PHERGain-II trial, patients will receive preoperative treatment with trastuzumab and pertuzumab, drugs aimed at blocking HER-2, without chemotherapy. Tumors will be scanned with magnetic resonance imaging before and after treatment to determine if the level of pathological response achieved after treatment can be predicted by non-invasive tumor imaging.
The PHERGain-I Assay has previously explored the potential of a chemotherapy-free treatment approach in patients with HER2+ early breast cancer. The results, presented at the last ASCO annual meeting, were encouraging, as a significant proportion of patients had a pathological complete response (i.e. no signs of cancer at the time of surgery) after receiving preoperative treatment without chemotherapy. .
“Although this new therapeutic approach will not allow all patients to go without chemotherapy, it opens the door for us to design new ways to reduce the toxicity of antitumor therapies based on the tumor’s response to preoperative treatment,” explained the Dr. José Ángel Garcia Saenz. In this way, it would be possible to identify patients in whom targeted therapy alone can achieve results similar to those obtained with the administration of targeted therapy plus chemotherapy, which is the norm today.
A total of 393 patients from 70 health centers in Spain, France, Germany, UK and Italy will participate in the PHERGain-II study.