UNICANCER's Phase 3 Clinical Trial to Investigate Optimal Personalized Treatment of Early Breast Cancer in Younger Women

Strategic Insights -

A clinical trial, led by UNICANCER and in collaboration with the University of Warwick, aims to determine the effectiveness of a genetic test, Prosigna, in deciding whether to administer chemotherapy to premenopausal women with hormone-dependent breast cancer. The trial seeks to assess whether optimized hormonal treatment, including ovarian suppression, can be as effective as chemotherapy in preventing cancer recurrence. The study involves 3380 participants from the USA and is not yet open for recruiting.

Key Takeaways:

  • The trial aims to determine whether the use of a genetic test (Prosigna) can decide whether or not to administer chemotherapy to premenopausal women with hormone-dependent breast cancer, producing results as good as standard treatment.
  • The study will assess whether optimized hormonal treatment (including suppression of ovarian function) is as effective as chemotherapy in preventing cancer recurrence in patients with a low Prosigna score.
  • The study will compare the efficacy of treatment Prosigna-guided versus systematic chemotherapy in terms of recurrence, quality of life, and economic aspects.
  • The primary endpoint of the study is to measure the time elapsed between the start of participation in the study and the appearance of an event indicating a return of the cancer.
  • The study includes women in major premenopausal diagnosed with invasive, hormone receptor-positive (ER+) and HER2-negative breast cancer who have undergone recent breast and axillary surgery.
  • The study excludes postmenopausal women, women with stage IV breast cancer, women who have already received adjuvant systemic treatment, women with a recent history of invasive cancer, pregnant women, or women who are breastfeeding.

Statistics:

  • 3380 participants will be involved in the trial from the USA.
  • 70-80% of breast cancers are so-called "hormone-dependent" (HR+)/HER2-.
  • The trial will evaluate the efficacy of Prosigna-guided treatment versus systematic chemotherapy in 70% of cases with a low Prosigna score.
  • The study will collect information on the quality of life of patients for 5 years following randomization.
  • The clinical trial is being conducted by UNICANCER and in collaboration with the University of Warwick.

Sources:

  • ClinicalTrials.gov
  • NCT07106632
  • Contify.com, 2017