Study: New therapeutic strategy to avoid chemotherapy in patients with early HER-2+ breast cancer

World Cancer Day: Breast cancer accounts for 14% of all diagnosed cancer cases in the US and remains one of the most common causes of death among women in the country

The PHERGain II clinical trial, promoted by MEDSIR, aims to demonstrate the viability of a non-chemotherapy alternative for treating those patients who can achieve a similar response with less toxic treatment
Participating patients will receive pre- and postoperative treatment with drugs aimed at blocking the HER2 protein, without the subsequent chemotherapy
Tumors will be scanned by magnetic resonance imaging before and after preoperative treatment to assess whether the response to treatment could be predicted in the future without the need for surgery
The goal is to find an effective therapeutic strategy that can reduce the use of chemotherapy and improve the quality of life of patients without compromising the clinical effectiveness of their treatment

MEDSIR, a global company dedicated to independent clinical research in oncology, has initiated the PHERGain II clinical trial to demonstrate that in patients with HER2-positive early breast cancer with a good prognosis, a chemotherapy-free therapeutic approach can be as effective as the current standard of care, which involves the use of this generally more toxic treatment.

The goal of PHERGain II study is aligned with one of the top priorities in cancer research according to the associations of reference such as the American Society of Clinical Oncology (ASCO): that clinical investigation in oncology prioritizes the reduction of toxicity associated with the treatment of cancer.

“Given the side effects and the impact of chemotherapy on the quality of life of patients with early breast cancer, it is advisable to find a new therapeutic strategy that allows dispense with traditional systemic chemotherapy in those patients who can achieve a similar response with a less toxic treatment”, explained Dr. Antonio Llombart, head of the Medical Oncology Service at the Arnau de Vilanova Hospital (Valencia) and principal investigator of the study.

HER-2+ breast cancer is a type of cancer with a high presence of human epidemic growth factor receptor 2 (HER2), 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 are removed by surgery and treated with therapies aimed at blocking HER2. However, even in patients with a good prognosis, the combination with chemotherapy is still part of the standard treatment to prevent the tumor from coming back after surgery.

For these patients, there is great interest in exploring a combination or optimized sequence of drugs targeting HER2 that eliminates the need for chemotherapy without affecting the clinical benefit of the treatment, which could positively impact their quality of life.

In the PHERGain-II trial, patients will be given preoperative treatment with trastuzumab and pertuzumab, aimed at blocking HER2, without chemotherapy. MRI will scan tumors before and after treatment to determine if the pathological response level after treatment can be predicted by non-invasive tumor imaging. After surgery, depending on the response to therapy with trastuzumab and pertuzumab, treatment with the same combination of drugs or with T-DM1 (another HER2 blocking drug) will be continued, reserving the use of chemotherapy only to those patients who have responded worse to preoperative treatment and who therefore have a worse prognosis.

The earlier PHERGain-I clinical trial has already 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, since a significant number of patients had a complete pathological response (that is, total absence of 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 dispense with chemotherapy, it opens the door for us to design new ways to reduce the toxicity of antitumor therapies based on the response of the tumor to preoperative treatment”, explained Dr. Llombart. In this way, it would be possible to determine those 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.

To confirm that this strategy is completely effective and to be able to implement it in routine clinical practice, the investigators will carry out a three-year follow-up of these patients to determine their evolution and detect if the relapse rate is equivalent to that obtained through the use of chemotherapy.

A total of 393 patients from 70 health centers in Spain, France, Germany, the United Kingdom, and Italy will participate in the PHERGain-II study.

Latest data on cancer in the USA

Almost 1.9 million new cancer cases are expected to be diagnosed in 2021, among which there will be an estimated 281,550 new cases of breast cancer diagnosed in women1. Forecasted national expenditures for cancer care in the United States in 2018 were $150.8 billion. In future years, costs are likely to increase as the population ages, more people get sick, new, and often more expensive treatments are adopted as standards of care2.

Although progress has been made in the past years, there is still much work that remains to be done. As of January 2019, there were an approximate 16.9 million cancer survivors in the United States, and this number is projected to increase to 22.2 million by 20302. More people will suffer from the disease, and those who survive will end up at risk of developing long-term side effects from aggressive cancer treatments and chemotherapy, even months or years after being treated. With the number of long-term cancer survivors increasing, improving their overall quality of life should become a crucial focus in developing novel therapeutic strategies. That is why studies like PHERGain II are so important. Thousands of women can avoid chemotherapy, with all its side effects, but still achieve good long-term results.

About World Cancer Day

World Cancer Day takes place every year on the 4th February and is the uniting global initiative under which the world comes together to raise the profile of cancer in a positive and inspiring way. Spearheaded by the Union for International Cancer Control (UICC), the day intends to save millions of preventable deaths each year by raising awareness and improving education about the disease while calling for action from governments and individuals across the world.

World Cancer Day 2021 is led by the theme “I Am and I Will”, an empowering call for personal commitment that represents the power of our actions taken now to reduce the growing impact of cancer.

About MEDSIR

MEDSIR is a global company with offices in Barcelona (Spain) and New Jersey (United States) that is dedicated to the development and strategic management of clinical trials for independent cancer research. The company aims to identify innovative treatments that improve the quality of life of cancer patients and obtain the necessary funding to study them in a clinical context.

Founded in 2012 by experts in oncology, MEDSIR unites academic talent with an international network of more than 300 collaborators and 720 investigators in 12 countries – and the resources provided by the pharmaceutical industry to carry out innovative clinical trials and develop new treatments. Made up of 50 professionals, the company can manage all the phases of independent clinical research; from the design of a study, the search for funding, to the publication of results -and integrates technology and digitization to optimize all stages of the process.

Since its formation, MEDSIR has received the support of more than 25 sponsors to conduct over 40 independent clinical trials in oncology and other diseases such as COVID-19.

For more information: www.medsir.org