Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests

Rationale: Around 70 to 80% of breast cancers are so-called "hormone-dependent" (HR+)/HER2-. For more than 50 years, studies have shown that chemotherapy and optimised hormonal treatments (hormone therapy), including a drug associated with ovarian suppression (OFS), improve survival in patients with these cancers, which are characterised by a high risk of relapse. However, younger patients suffer more side effects than older women, particularly from chemotherapy. This can affect their quality of life and reduce their ability to work. For post-menopausal women, genetic tests exist to assess w

Trial Details

NCT ID
NCT07106632
Phase
PHASE3
Sponsor
UNICANCER
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • test-directed treatment: allocated treatment will depend on the PAM50 score result (centrally assessed) : chemo-endocrine therapy or endocrine therapy alone
  • In the control arm, the treatment will be as standard of care : chemo-endocrine therapy
Locations (sample)
  • Brussels, Belgium|50.85045,4.34878
  • Charleroi, Belgium|50.41136,4.44448
  • Haine-Saint-Paul, Belgium|50.45544,4.1885
  • Namur, Belgium|50.4669,4.86746
  • Ottignies, Belgium|50.66535,4.56679

Key Eligibility Criteria

  • Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their wri…
  • . Premenopausal defined by patient that are not post-menopaused
  • Age ≥ 35 years
  • Diagnosis of invasive HR-positive (ER≥10% of tumour cells stained positive and any PR expression) HER2-negative (IHC score 0-1+ or 2+ with negative…

For full eligibility, visit ClinicalTrials.gov.

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