Prediction of Treatment Efficacy of the Combination of Palbociclib/(Letrozole or Anastrozole) in First Line Metastatic Women With Luminal, HER2 Negative Advanced Breast Cancer, Using Infrared Laser Spectroscopy Analysis on Liquid Biopsies.

This study is a multicenter, international, open-label phase II study. Based on inclusion/exclusion criteria, eligible pre and postmenopausal patients with newly diagnosed metastatic luminal hormone receptor-positive and HER2 negative breast cancer, will be prospectively treated with a standard combination of hormone therapy (Letrozole or Anastrozole) and Palbociclib. This combination will continue until progression. Treatment response will be evaluated every three months using clinical and radiological assessments (Revised RECIST guidelines). Patients will undergo serial liquid biopsies (blo

Trial Details

NCT ID
NCT05190094
Phase
PHASE2
Sponsor
International Cancer Research Group, United Arab Emirates
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Combination of Palbociclib and aromatase inhibitor (Letrozole or Anastrozole)
Locations (sample)
  • Blida, Algeria|36.47004,2.8277
  • Sétif, Algeria|36.19112,5.41373
  • Amman, Jordan|31.95522,35.94503
  • Riyadh, Saudi Arabia|24.68773,46.72185
  • Riyadh, Saudi Arabia|24.68773,46.72185

Key Eligibility Criteria

  • To be enrolled in the study, patients should meet the following inclusion criteria:
  • Written informed consent before beginning specific protocol procedures including expected cooperation of the patients for the treatment and follow-…
  • Postmenopausal women or pre/peri-menopausal women with Surgical oophorectomy (preferred) or Analogs of LHRH.
  • Performance status \< 3 (according to WHO criteria).

For full eligibility, visit ClinicalTrials.gov.

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