Registration Links (4 Options)
Speaker RegistrationPatient RegistrationRegister For Clinical TrialsCommunity Network
ONC-ORG

Clinical Trials

Search trials funded by the NIH, NCI and pharmaceutical sponsors — or let a navigator match you.

Not sure which trial fits? A navigator will search for you at no cost.Get Matched
NCT06974929Phase 1, Phase 2Recruiting

A Clinical Study of HRS-6209 Combined With Other Treatment Regimens in Patients With Breast Cancer

Jiangsu HengRui Medicine Co., Ltd. · Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin Municipality

This is a study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HRS-6209 combined with other treatment regimens in breast cancer patients, and preliminarily observe its anti-tumor efficacy.

Eligibility: 18 Years to 75 Years · Female · 1. Women aged 18-75 years. 2. ECOG performance status 0-1. 3. Menopausal status. 4. Evidence of radiographic disease progression during or after the last systemic anti-tumor therapy prior to the first study drug administration. 5. At baseline, there must be at least one measurable, extracranial lesion that meets RECIST v1.1 criteria. 6. Expected survival \> 3 months. 7. Women of childbearing potential must agree to use highly effective contraceptive measures during the study treatment and for 6 months after the end of treatment. Women of childbearing potential must have a negative serum HCG test within 7 days prior to study enrollment and must not be breastfeeding. 8. Voluntarily agree to participate in this clinical trial, willing and able to comply with the study visits and procedures, understand the study procedures, and have signed the informed consent form.

Apply for this TrialDetails
NCT05190094Phase 2Recruiting

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.

International Cancer Research Group, United Arab Emirates · EHS LCC Blida, Medical Oncology Center, Blida

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".

Eligibility: 18 Years to · Female · To be enrolled in the study, patients should meet the following inclusion criteria: 1. 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. 2. Postmenopausal women or pre/peri-menopausal women with Surgical oophorectomy (preferred) or Analogs of LHRH. 3. Performance status \< 3 (according to WHO criteria). 4. Histologically confirmed breast cancer (Luminal A or B). 5. Estrogen Receptor positive (ER \> 1%). 6. HER2 negative (score 0 or 1 by immunochemistry), FISH negative if IHC score 2. 7. Clinical stage IIIb \& IV. 8. Either: 1. Women with De novo advanced luminal HER2 negative advanced breast cancer without other prior systemic treatment for advanced disease. 2. 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). 9. Measurable or evaluable disease. 10. Hematology: * Neutrophil count ≥ 1.5 G/L, * Platelet count ≥ 100 G/L, * Leucocyte count \> 3.0 G/L, * Hb\> 9g/dl. 11. 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). 12. Renal function: • Serum creatinine ≤1.5xUNL (and if Serum creatinine \>1.5xUNL, creatinine clearance ≥40 mL/min), 13. Metabolic function: • Serum calcium ≥ lower limit of normal. 14. 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. 15. Patients with negative Human Immunodeficiency Virus (HIV) and/or Hepatitis B and/or Hepatitis C results.

Apply for this TrialDetails