Optima-young: Rethinking
Chemotherapy
About treatment
for breast cancer
Even after successful surgery, almost all patients are offered additional treatments, known as adjuvant therapy. This approach increases the chances of a definitive cure for the cancer. Adjuvant therapy can be focused on the operated area (by radiotherapy) or on the whole body (by chemotherapy (CT) or hormone therapy).
Until about 15 years ago, breast cancer was generally treated as a single disease, with chemotherapy being the standard treatment for all patients. However, advances in research have revealed that breast cancer is made up of several distinct types that behave differently and require personalized therapeutic approaches. While some forms of breast cancer clearly require chemotherapy, others may not benefit from it.
The most common form of breast cancer is hormone-sensitive, in which cancer cells depend on the female hormone estrogen to grow.
The Optima-young trial focuses on this particular type of breast cancer, known as hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative, in young women.
Numerous data confirm the significant benefits of hormonal tablet therapy over a period of five to ten years for these patients. However, the role of chemotherapy in this group is less certain. For some patients with this type of cancer hemotherapy may bring little or no benefit. Moreover, chemotherapy is responsible for long-term toxicity that affects quality of life, and is even more marked in younger patients. De-escalation of chemotherapy could therefore help improve the quality of life of these pre-menopausal women.
About Optima-young
Background to hormone-dependent breast cancer. 70-80% of breast cancers (BC) are hormone-dependent (i.e. hormone receptor-positive (HR+) and human epidermal growth factor receptor-negative (HER2-)). When choosing treatments for this type of cancer, doctors base their decisions on clinico-pathological and biological criteria (speed cancer progression, tumor size and whether or not lymph nodes have been invaded). However, in the light of previous studies, these criteria do not appear to be sufficiently relevant, since for some patients, chemotherapy appears to bring no greater benefit than treatment with hormone therapy alone. Chemotherapy has side effects that can have a major impact on patients' quality of life during and even after treatment.
There are now several genomic tests that provide more precise information than the criteria traditionally used for individual breast cancers, to help determine which patients need chemotherapy and which might not benefit and safely avoid chemotherapy.
What
is the
goal
of the
study ?
The aim of this trial is to show that suppression of chemotherapy in premenopausal HR+/HER2- breast cancer patients, guided by a Prosigna® genomic test, is no less effective than standard treatment (which corresponds to chemotherapy and hormone therapy) in preventing cancer recurrence. The results of this research will enable us to better guide patients' treatment, particularly the administration of chemotherapy, and improve their quality of life. The research will take into account not only the relapse rate, but also quality of life, medico-economic costs and the patient's perception of certain aspects of her participation in the study (such as her motivation to take part in the research, the participant's assessment of risks and toxicities).
Find out more about genomic testing
Over the past fifty years, doctors have used simple criteria to prescribe chemotherapy: the size of the tumour, its spread to neighbouring lymph nodes and its appearance under the microscope. However, these methods have their limitations, and can lead to patients receiving chemotherapy it isn't necessary. Chemotherapy is risky, and can cause a variety of short- and long-term side effects. For some patients, starting hormone therapy alone can be just as effective, avoiding the delays caused by unnecessary chemotherapy.
In recent years, advanced tests have been developed to study the genes present in cancer cells and the degree activity of some of these genes. They are used to guide and improve treatment choices by providing precise information about each cancer. The test we use in Optima-young is called Prosigna® . It analyzes gene activity in cancer cells and gives a score from 0 to 100 for the risk of cancer recurrence. The test will be performed on a tumor sample taken during surgery as part of routine care, and no further samples will be required.
About genomic testing
Up until about 15 years ago, breast cancer was generally treated as a single disease, with chemotherapy being the standard treatment for all patients. However, advancements in laboratory research have revealed that breast cancer consists of multiple distinct types—possibly up to ten—each behaving differently and requiring personalized treatment approaches. While some forms of breast cancer clearly require chemotherapy, others may not.
The most common form of breast cancer is hormone-sensitive, where cancer cells rely on the female hormone oestrogen for growth.
The Optima-young study focuses on this particular type of breast cancer, often referred to as oestrogen receptor (ER) positive and Human Epidermal Growth Factor Receptor 2 (HER2)-negative, among young women. Extensive evidence supports the significant benefits of hormone tablet therapy over five to ten years for these patients.
However, the role of chemotherapy in this group is less certain. For some patients with this diagnosis, chemotherapy may provide little to no benefit, making it more crucial to prioritize effective hormone tablet treatment from the outset. Furthermore, chemotherapy is responsible for long term toxicity that affects the quality of life, which is even more noticeable among younger patients. Chemotherapy de-escalation could therefore participates to increase the quality of life of these pre menopausal women.
About the WeShare digital platform
WeShare is a digital infrastructure funded by the French government and sponsored by Unicancer, which aims to develop national patient-centered research platform for cancer centers. It provides digital technologies and tools for cancer research, with a focus on quality of life and social sciences. It aims to become a sustainable digital platform serving mainly European countries to facilitate digital and innovative research.
The Optima-young trial will use some of the digital tools available on the WeShare platform To do so, patients will need to register on the WeShare platform. The WeShare account is personal to the patient, and will enable them carry out key trial activities remotely, such as consulting information documents and study materials, viewing briefing notes, and completing the electronic questionnaires required for the study. These functionalities may vary from country to country, but questionnaire completion will be available for all countries participating in the Optima-young trial.
