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Start a "revolutionary" clinical trial against breast cancer based on a new immunotherapy


The Mussic Institute of Biosanitary Research Virgen del Arrixaca (IMIB) participates in a clinical trial against pioneer breast cancer to use a new immunotherapy in the initial phases of the disease, according to sources informed of Orion Communication.

The study of this approach promoted by Roche, the company that has developed the drug, is "revolutionary", in the words of the Head of the Medical Oncology Service of the Hospital Clínico Universitario Verge de Arrixaca and clinical assistant director of the IMIB, Dr. José Luis Alonso, because "he applied an immunotherapist, the atezolizumab, which until now had only been used in lung and bladder tumors in advanced stages, showing himself very effective ".

"In this clinical trial, we will apply before removing the tumor in women recently diagnosed with breast cancer, as well as in the post-surgical phase in combination with conventional treatment," Alonso said.


The emergence of immunotherapy in the fight against cancer has meant a radical change in the scene. This biological therapy is to stimulate the natural defenses of the body in order to fight cancer by using both substances produced by the body and manufactured in a laboratory to improve or restore the function of the immune system, as highlighted by the same sources.

Its efficacy has already been demonstrated in various types of tumors as it contributes to increase survival, reduce the size of tumors, extend cures and improve the quality of life of patients. But there is still a lot to be investigated so that they are applicable treatments in all cases.

In fact, this international clinical trial, involving fourteen Spanish centers, is aimed at a very specific type of breast cancer: the HER2 tumor subtype positive, a more aggressive variant that accounts for 20% of the 27,000 new cases diagnosed each year throughout the country. In the Murcia Region, the annual incidence is around 700 cases.

For this reason, researchers at IMIB need to recruit patients from the Region that wish to be part of the trial. "But the first thing to note is that it is a double-blind study, that is, a group of women will take the drug while another group will be given the placebo," as Dr. Mª explains. Dolores Jiménez Lucas, researcher of the group of Medical Oncology of the IMIB-Arrixaca.

In this sense, he points out that it is the most correct system to verify its effectiveness with scientific rigor. "Evidently, the trial starts because there are expectations that help improve the survival and quality of the patients, as well as reduce the size of the tumor by facilitating their surgical removal, but we submit them to the test to be able to demonstrate these expectations, "he underlines.

However, Jiménez Lucas emphasizes that "all the participants will benefit from receiving very precise clinical control. In addition, treatment with other immunotherapies (pertusumab and trastuzumab) will be applied, both before and after the # 39; operation, which is also a novelty in dealing with this type of tumors ".


The responsible for the Coordination of Clinical Trials of Medical Oncology at IMIB-Arrixaca, Ana Pérez, specifies that "the fundamental diagnostic criteria to be included in this essay are that the patient finishes being diagnosed with a positive HER2 breast cancer, who have not yet received treatment or have undergone surgery. In addition, the tumor should not measure more than 2 centimeters nor metastasize in other organs, although it is necessary that they have an affectation axillary ".

Alonso specifies that these requirements are orientative, and that the patients who wish to participate always have to consult their oncologist, so that the specialist resolves if they fulfill the conditions to be included in the test, since there may be other obstacles Basis that only the responsible doctor can assess.

"In the case that the profile corresponds to the requirements, we have asked for the different services of Medical Oncology of the Region of Murcia that contact our service to the Arrixaca and we will process the inclusion of the patient in the clinical trial ", stresses Alonso.

On the possible side effects, IMIB-Arrixaca oncologists stress that immunotherapy does not cause alopecia, nausea or a low mood, although there is a risk of cardiotoxicity, but it can be effectively monitored with follow-up Clinic that is carried out by all participants.

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