Status:
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.
Lead Sponsor:
International Cancer Research Group, United Arab Emirates
Collaborating Sponsors:
King Saud Medical City
Max-Planck-Institut für Quantenoptik (MPQ), and Faculty of Physics at Ludwig-Maximilians-Universität München (LMU), Garching, Germany
Conditions:
Hormonal Receptors Positive, HER2 Negative, Advanced Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 r...
Detailed Description
Background: The standard therapy of first-line metastatic luminal hormone receptor positive, HER2 negative breast cancer, is based upon the combination of hormone therapy (HT): an aromatase inhibitor...
Eligibility Criteria
Inclusion
- 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-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).
- Estrogen Receptor positive (ER \> 1%).
- HER2 negative (score 0 or 1 by immunochemistry), FISH negative if IHC score 2.
- Clinical stage IIIb \& IV.
- Either:
- Women with De novo advanced luminal HER2 negative advanced breast cancer without other prior systemic treatment for advanced disease.
- Women with luminal HER2 negative advanced breast cancer either with secondary resistance (relapse after 2 years of adjuvant hormone therapy or within 12 months of completion of adjuvant HT) or sensitivity to adjuvant HT (relapse \> 12 months after completion of adjuvant HT).
- Measurable or evaluable disease.
- Hematology:
- Neutrophil count ≥ 1.5 G/L,
- Platelet count ≥ 100 G/L,
- Leucocyte count \> 3.0 G/L,
- Hb\> 9g/dl.
- Hepatic function:
- Total bilirubin ≤ 1.5 times the upper normal limit (UNL),
- ASAT ≤ 2.5xUNL,
- ALAT ≤ 2.5xUNL,
- Alkaline phosphatase ≤ 2.5 times the upper normal limit (UNL).
- Renal function:
- • Serum creatinine ≤1.5xUNL (and if Serum creatinine \>1.5xUNL, creatinine clearance ≥40 mL/min),
- Metabolic function:
- • Serum calcium ≥ lower limit of normal.
- Negative pregnancy test (urine or serum) within 7 days before registration for all women of childbearing potential. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment.
- Patients with negative Human Immunodeficiency Virus (HIV) and/or Hepatitis B and/or Hepatitis C results.
Exclusion
- To be enrolled in the study, patients should meet the following exclusion criteria:
- 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.
- No willingness to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months post-treatment.
- Any form of breast cancer other than those described in the inclusion criteria, particularly inflammatory and/or loco-regional disease (stages I, II \& IIIa).
- Non-evaluable tumor.
- Bilateral breast cancer.
- Patients with a history of other cancer, except in situ cervical cancer or baso-cellular skin cancer, considered cured.
- Patient has another disease, which is deemed incompatible with the inclusion in the protocol.
- Heart, kidney, medullary, respiratory or liver failure.
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) at baseline.
- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease at baseline,
- Acute urinary infection, ongoing hemorrhagic cystitis at baseline.
- Uncontrolled diabetes.
- Symptomatic or progressive disorder of the central nervous system (CNS) at baseline.
- Patients with positive Human Immunodeficiency Virus (HIV) and/or Hepatitis B and/or Hepatitis C results.
- Significant psychiatric abnormalities.
- History of hypersensitivity to studied treatment or excipients.
- Known previous or ongoing abuse of narcotic drug, other medication or alcohol.
- Any investigational agent within 30 days before initiation of study treatment.
- Patient unwilling or unable to comply with study requirements.
Key Trial Info
Start Date :
December 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05190094
Start Date
December 20 2022
End Date
June 1 2026
Last Update
May 7 2025
Active Locations (7)
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1
EHS LCC Blida, Medical Oncology Center
Blida, Algeria
2
University Hospital Sétif,
Sétif, Algeria
3
King Hussein Cancer Center (KHCC) - Amman
Amman, Jordan
4
King Saud Medical City - KSMC
Riyadh, Saudi Arabia