First-line Treatment Study of Palbociclib with Letrozole or Anastrozole for Women with Hormone Receptor Positive, HER2 Negative Advanced Breast Cancer Using Infrared Laser Spectroscopy on Blood Samples to Predict Treatment Response

What this Trial Is About

Researchers are evaluating the combination of Palbociclib and hormone therapy Letrozole or Anastrozole in women with newly diagnosed metastatic luminal hormone receptor-positive and HER2 negative breast cancer. This international, multicenter, open-label phase II study aims to assess the treatment response and the use of Quantum Optics technology on liquid biopsies to predict individual therapeutic responses. The study addresses the current challenge that only about half of patients benefit from this treatment combination, with no existing markers to identify responders beforehand. Participants will receive Palbociclib 125 mg daily, three weeks on and one week off, with dose adjustments as needed combined with an aromatase inhibitor Letrozole 2.5 mg or Anastrozole 1 mg daily. This treatment will continue until disease progression, typically over about two years. Premenopausal patients may also receive ovarian function suppression. Molecular fingerprinting by Quantum Optics will be performed on blood samples at enrollment, monthly for the first three months, and then every three months until relapse, alongside clinical and radiological evaluations every three months. During the study, participants will undergo regular clinical and radiological assessments based on Revised RECIST guidelines to monitor treatment response every three months for up to two years. Blood tests for plasma molecular fingerprinting will help predict treatment efficacy. Researchers will measure objective clinical response rates, progression-free survival, clinical benefit, and safety throughout treatment. The study also explores the role of molecular fingerprinting in predicting early progression and relapse, with ongoing safety monitoring until progression or study end.

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.