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 is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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 (blood tests) for plasma molecular fingerprinting by the Quantum Optics technology. This study will be the first program exploring the adjunction of the Quantum Optics technology on liquid biopsies to define individual 'molecular fingerprinting profiles' to predict the individual therapeutic effects of Palbociclib combined with Aromatase Inhibitors (AI) (plus ovarian function suppression (OFS) for pre/peri-menopausal patients) in luminal hormone receptor-positive and HER2 negative advanced breast cancer. Batteries of algorithmic tests will integrate the variables obtained by Quantum Optics (to evaluate the efficacy or not of the combination of Palbociclib + Aromatase Inhibitors (AI) ). This approach introduces the concept of singularity to break from the classic idea of "one size fits all".
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pisemna zgoda pacjenta na uczestnictwo w badaniu przed jego rozpoczęciem
- •Kobieta w menopauzie lub po chirurgicznym usunięciu jajników, lub przyjmująca leki hamujące hormony
- •Ogólny stan zdrowia pozwalający na leczenie (skala WHO poniżej 3)
- •Potwierdzony histologicznie rak piersi typu luminalny A lub B
- •Dodatni receptor estrogenowy (ER > 1%)
- •Ujemny receptor HER2 (wynik 0 lub 1)
- •Zaawansowany rak piersi (stadium IIIb lub IV)
- •Prawidłowe wyniki badań krwi, wątroby, nerek i metabolizmu
✗ Disqualifies
- •Pacjenci płci męskiej
- •Dodatni receptor HER2 lub nieznany status receptorów
- •Rak piersi potrójnie ujemny (ER < 1%)
- •Ciąża, karmienie piersią lub planowanie ciąży w ciągu 6 miesięcy po leczeniu
- •Brak zgody na stosowanie skutecznych metod antykoncepcji podczas i 6 miesięcy po leczeniu
- •Inne typy raka piersi niż określone w kryteriach włączenia, w tym zapalny lub ograniczony do piersi (stadium I, II, IIIa)
- •Historia innego nowotworu (z wyjątkiem raka szyjki macicy in situ lub białaczki skóry)
- •Poważne problemy zdrowotne niezgodne z uczestnictwem w badaniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- May 7, 2025
- Sex
- Female only
Therapies / drugs in trial
Locations (7)
EHS LCC Blida, Medical Oncology Center
Blida, Algeria
University Hospital Sétif,
Sétif, Algeria
King Hussein Cancer Center (KHCC) - Amman
Amman, Jordan
King Saud Medical City - KSMC
Riyadh, Saudi Arabia
Medical Oncology Center- King Saud University Medical City (KSUMC)
Riyadh, Saudi Arabia
Medical Oncology Department- King Fahad Medical City (KFMC)
Riyadh, Saudi Arabia
Oncology Center Department, King Faisal Specialist Hospital and Research Centre -KFSH & RC
Riyadh, Saudi Arabia
Trial contact
M.R.K. BAHADOOR, MD, EMBA
Farida DABOUZ, PhD
Contact information from ClinicalTrials.gov. Contact in English.
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Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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