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- Breast Cancer and Therapeutic De-escalation: A Study to Evaluate the Omission of Chemotherapy in Certain Patients with Early-Stage Breast Cancer
Breast cancer is the most common cancer in women - it accounts for 33% of new cancer cases every year. It affects more than 60,000 women a year in France, but its survival rate is 87% at the five-year mark. It should be noted that less than 1% of breast cancers occur in men. Cancer cells may be contained within the lobules (the group of glands that produce milk) or ducts of the breast (which carry milk), or they may invade nearby tissues, such as lymph nodes under the armpit. In the first case, we are talking about carcinoma in situ and in the second - of invasive carcinoma. Cancer cells can then pass into the blood and cause metastases.
Can chemotherapy be avoided for patients in whom the risk of relapse is low? That's the whole point of NoLEEta : A very large-scale international Phase 3 study sponsored by Unicancer. This trial is conducted in patients with hormone-dependent localized breast cancer for whom the standard treatment is hormone therapy and adjuvant chemotherapy (after surgery).
The objective of NoLEEta: to evaluate the clinical effect, after surgery, of suppressing chemotherapy in certain patients whose benefit from chemo is low and who present a moderate risk of relapse.
"These women could be spared the side effects of chemotherapy while benefiting from similar survival results. Such a therapeutic adaptation, if the results are confirmed, would constitute a major advance for the quality of life of our patients", declares Professor François-Clément Bidard.
Learn more about breast cancers
NoLEEta: No chemotherapy in intermediate-risk HR+ HER2- early breast cancer treated with Ribociclib in the adjuvant setting-A non-inferiority phase III trial – Poster session (Breast Cancer—Local/Regional/Adjuvant), Professor François-Clément Bidard - June 1, 2026
