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Personalized Adjuvant Treatment for HR+/HER2- breast cancer FOR YOUNG patients

Project description

Assays for personalised breast cancer treatment

Approximately 7 million women are living with or beyond breast cancer, with 25 % of breast cancer cases in the EU occurring in premenopausal women. These women face burdensome treatments such as chemotherapy. While gene-expression assays can help identify postmenopausal patients who can avoid chemotherapy, studies focusing on high-risk premenopausal women treated with optimal endocrine therapy are lacking. The EU-funded PATH-FOR-YOUNG project aims to evaluate the role of specific assays to guide treatment for 5 000 patients, building on an ongoing twin randomised controlled trial. The project will also explore digital self-management tools to support patients, particularly during endocrine therapy, improving quality of life. A comprehensive health technology assessment will help facilitate cross-country implementation.

Objective

Worldwide, ~7 million women live with or beyond Breast Cancer (BC), as 10-year survival rates exceeding 80% for early-stage (I-III) BC. Premenopausal BC accounts for 25% in the EU and 55% in low/middle income countries. Most premenopausal women with BC have high risk of recurrence, therefore standard treatment includes adjuvant chemo- (CT) and endocrine therapy (ET). However, treatment has substantial physical, emotional and social burden, which is often more pressing for younger compared to older patients.
Gene-expression assays are used for post-menopausal patients to identify women who can safely forego CT without detriment on clinical outcomes, preserving Quality of Life (QOL). However, a definitive study has yet to be conducted among premenopausal women with high-risk HR+HER2-BC. The primary objective of PATH-FOR-YOUNG is to conduct a pragmatic randomized controlled trial (RCT) with 5000 patients validating the use of a gene-expression assay to drive adjuvant treatment decisions in this target population.
PATH-FOR-YOUNG aims to achieve its objective in 7 years. The project (i) builds on and complements an ongoing twin RCT to ensure timely recruitment, (ii) leverages on a large international consortium of oncologists, pathologists, patient representatives, psychologists, sociologists, ethics and communication experts, biostatisticians, health economists, and technology providers, to assure complementary and multidisciplinary expertise, and (iii) highlights patient-engagement, participatory care, and early involvement of end users. PATH-FOR-YOUNG will also study implementation of digital self-management to support patients throughout the cancer journey and particularly while on ET to improve QOL and medication adherence. A full HTA will ensure a path towards cross-country implementation.
PATH-FOR-YOUNG has the ambition to improve BC care, fully integrating the predictive, personalized, preventive, and participatory principles of health management.

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(opens in new window) HORIZON-HLTH-2024-DISEASE-03-two-stage

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Coordinator

UNICANCER
Net EU contribution

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€ 4 447 320,40
Address
101 RUE DE TOLBIAC
75013 Paris
France

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Ile-de-France Ile-de-France Paris
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Research Organisations
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Participants (22)

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