Comparison of Clinical Efficacy Between Letrozole + Ribociclib and Fulvestrant + Letrozole + Ribociclib in Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

Aromatase inhibitor (AI) + CDK4/6 inhibitor is settled down as the standard first line therapy for HR+/HER2- metastatic breast cancer and all three CDk4/6 inhibitors, palbociclib, ribociclib, and abemaciclib are currently available for same indications. However, there is no effective treatment strategy for patients who have progressed on AI+CDK4/6 inhibitor. In particular, the clinical efficacies of subsequent hormone therapy are lowered when ESR1 mutations, one of mechanisms of AI resistance occur. In the PADA-1 trial, when ESR1 mutations in ctDNA were detected in patients treated with AI+CDK

Trial Details

NCT ID
NCT05816655
Phase
PHASE2
Sponsor
Korea University Guro Hospital
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Fulvestrant plus AI plus ribociclib
  • AI plus ribociclib
Locations (sample)
  • Seoul, South Korea|37.566,126.9784
  • Seoul, South Korea|37.566,126.9784

Key Eligibility Criteria

  • Female ≥ 19 years of age
  • Histologically confirmed unresectable, locally advanced or metastatic invasive breast cancer with hormone receptor positive/HER2 negative
  • No previous history of systemic endocrine or chemotherapy for metastatic, advanced breast cancer.
  • If the patient has received AI as adjuvant endocrine therapy, the treatment free interval (TFI) should be more than 12 months after the end of adju…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find ER/PR Positive (Hormone Receptor Positive) Breast Cancer Trials on Trialify →