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".
Written informed consent before beginning specific protocol procedures including expected cooperation of the patients for the treatment and follow-up must be obtained and documented according to the local regulatory requirements.
Postmenopausal women or pre/peri-menopausal women with Surgical oophorectomy (preferred) or Analogs of LHRH.
Performance status < 3 (according to WHO criteria).
Histologically confirmed breast cancer (Luminal A or B).
Male patients.
HER2 positive tumors or unknown HR/HER2 status.
Triple-negative Breast Cancer (ER<1%).
Pregnant or breast-feeding women, or those who plan to become pregnant within 6 months post-treatment.
Single group
Combination of Palbociclib and aromatase inhibitor (Letrozole or Anastrozole)
DrugA combination of Palbociclib (125 mg daily per os (3 weeks on-1 week off) with dose adaptation according to safety profile) and non-steroidal aromatase inhibitor (Letrozole (2.5mg ) or Anastrozole (1mg) daily per os).
Rate of Objective Clinical Response
The objective clinical response will be assessed with Radiological evaluation according to the RECIST revised criteria for the combination of Palbociclib + Aromatase Inhibitors (AI)
Sensitivity and Specificity of prediction of the efficacy of the combination (palbociclib +AI).
Sensitivity and specificity of infrared laser spectroscopy analysis on liquid biopsies to predict the efficacy/resistance of the combination (Palbociclib + Aromatase Inhibitors (AI)) on an individual basis.
Rate of Progression-Free Survival (PFS)
Progression-Free Survival (PFS)
Rate of Clinical benefit
Clinical benefit is defined as CR/PR/Stabilization for more than 24 weeks
Rate of 'Objective' clinical benefit
'Objective' clinical benefit is defined as CR/PR/Minor response \[\> 0%\] more than 24 weeks).
Modification of the individual molecular fingerprinting
Modification of the individual molecular fingerprinting
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International Cancer Research Group, United Arab Emirates
Lead sponsor
King Saud Medical City
Collaborator
Max-Planck-Institut für Quantenoptik (MPQ), and Faculty of Physics at Ludwig-Maximilians-Universität München (LMU), Garching, Germany
Collaborator
King Abdallah University for Science and Technology (KAUST), Thuwal, Saudi Arabia.
Collaborator