Actively Recruiting
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.
Led by International Cancer Research Group, United Arab Emirates · Updated on 2025-05-07
80
Participants Needed
7
Research Sites
179 weeks
Total Duration
On this page
Sponsors
I
International Cancer Research Group, United Arab Emirates
Lead Sponsor
K
King Saud Medical City
Collaborating Sponsor
AI-Summary
What this Trial Is About
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".
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent.
- Female, postmenopausal or pre/peri-menopausal with surgical oophorectomy or LHRH analogs.
- Performance status less than 3 according to WHO criteria.
- Histologically confirmed luminal A or B breast cancer.
- Estrogen receptor positive with more than 1% expression.
- HER2 negative (score 0 or 1 by immunochemistry; FISH negative if IHC score 2).
- Clinical stage IIIb or IV disease.
- Either newly diagnosed advanced disease without prior systemic treatment, or advanced disease with secondary resistance or sensitivity to adjuvant hormone therapy.
- Measurable or evaluable disease.
- Adequate blood counts: neutrophils ≥ 1.5 G/L, platelets ≥ 100 G/L, leukocytes > 3.0 G/L, hemoglobin > 9 g/dl.
- Adequate liver function: total bilirubin ≤ 1.5x upper normal limit, ASAT ≤ 2.5x upper normal limit, ALAT ≤ 2.5x upper normal limit, alkaline phosphatase ≤ 2.5x upper normal limit.
- Adequate renal function: serum creatinine ≤ 1.5x upper normal limit or creatinine clearance ≥ 40 mL/min if serum creatinine > 1.5x upper normal limit.
- Serum calcium at or above the lower limit of normal.
- Negative pregnancy test within 7 days before registration for women of childbearing potential.
- Use adequate non-hormonal contraception during treatment if able to become pregnant.
- Negative tests for HIV, Hepatitis B, and Hepatitis C.
You will not qualify if you...
- Male patients.
- HER2 positive tumors or unknown HR/HER2 status.
- Triple-negative breast cancer (ER < 1%).
- Pregnant or breastfeeding women or planning pregnancy within 6 months post-treatment.
- Unwillingness to use effective contraception during treatment and for 6 months after.
- Breast cancer types other than described, including inflammatory or loco-regional disease (stage I, II, IIIa).
- Non-evaluable tumors.
- Bilateral breast cancer.
- History of other cancers except cured cervical in situ or baso-cellular skin cancer.
- Other diseases incompatible with study inclusion.
- Heart, kidney, medullary, respiratory, or liver failure, including significant cardiovascular disease or interstitial lung disease.
- Acute urinary infection or ongoing hemorrhagic cystitis.
- Uncontrolled diabetes.
- Symptomatic or progressive central nervous system disorders.
- Positive for HIV, Hepatitis B, or Hepatitis C.
- Significant psychiatric disorders.
- History of hypersensitivity to study treatments or excipients.
- Known or ongoing abuse of narcotics, medications, or alcohol.
- Use of investigational agents within 30 days before study treatment.
- Inability or unwillingness to comply with study requirements.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
EHS LCC Blida, Medical Oncology Center
Blida, Algeria
Not Yet Recruiting
2
University Hospital Sétif,
Sétif, Algeria
Not Yet Recruiting
3
King Hussein Cancer Center (KHCC) - Amman
Amman, Jordan
Actively Recruiting
4
King Saud Medical City - KSMC
Riyadh, Saudi Arabia
Not Yet Recruiting
5
Medical Oncology Center- King Saud University Medical City (KSUMC)
Riyadh, Saudi Arabia
Not Yet Recruiting
6
Medical Oncology Department- King Fahad Medical City (KFMC)
Riyadh, Saudi Arabia
Not Yet Recruiting
7
Oncology Center Department, King Faisal Specialist Hospital and Research Centre -KFSH & RC
Riyadh, Saudi Arabia
Not Yet Recruiting
Research Team
M
M.R.K. BAHADOOR, MD, EMBA
CONTACT
F
Farida DABOUZ, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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