CDK4/6 inhibitor
Drug(abemaciclib/ribociclib/dalpiciclib/palbociclib)
NCT Number: NCT07826052
This study is a prospective, open-label, multicenter, single-arm Phase II clinical trial. Based on the use of CDK4/6 inhibitors in endocrine-sensitive luminal-type (ER+/HER2-) breast cancer, it aims to explore the possibility of chemotherapy exemption in elderly patients (aged >65 years) with lymph node-positive, HR+/HER2- breast cancer.
Trial opening soon.
Get Notified65 year and older
Female
Interventional
Phase 2
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
a) Hematology (within 14 days, no transfusion): i. Hemoglobin (Hb) ≥90 g/L ii. Absolute neutrophil count (ANC) ≥1.5×10⁹/L iii. Platelets (PLT) ≥100×10⁹/L b) Biochemistry: i. Total bilirubin (TBIL) ≤1.5×ULN ii. ALT/AST ≤3×ULN iii. Serum creatinine (Cr) ≤1×ULN iv. Estimated creatinine clearance (CrCl) >50 mL/min (Cockcroft-Gault formula) 6. Consent & Compliance: Willing to participate, sign informed consent, and comply with follow-up.
Exclusion criteria
a) LVEF <50% (by echocardiography) b) Major cardiovascular/cerebrovascular events within 6 months before randomization: i. Unstable angina ii. Chronic heart failure iii. Uncontrolled hypertension (>150/90 mmHg) iv. Myocardial infarction or stroke c) Poorly controlled diabetes mellitus d) Severe hypertension 8. Known allergy to taxane-based drugs or their excipients. 9. Severe or uncontrolled infections. 10. History of psychoactive drug abuse (unable to abstain) or psychiatric disorders.
(abemaciclib/ribociclib/dalpiciclib/palbociclib)
Endocrine therapy (letrozole/anastrozole/exemestane)
Time frame: 5 years
5-year invasive disease-free survival (iDFS), defined as the time from randomization to the first occurrence of: local recurrence, distant metastasis, contralateral invasive breast cancer, death from any cause.
Time frame: Approximately 5 years
OS is defined as the time from randomisation until the date of death due to any cause.
Time frame: Up to approximately 3 years
ncidence of AEs, SAE, AESIs (interstitial lung disease, LVEF decrease), AEs resulting in study intervention interruption and discontinuation, etc.
Time frame: Up to approximately 3 years
Modified Geriatric-8 (G-8) screening tool
Time frame: Up to approximately 3 years
Clinical Frailty Scale (CFS, version 2.0)
Contact information is provided by the study sponsor or research team.
Zhimin shao, MD, PhD
CONTACT
jianjing hou
CONTACT
Fudan University
Other
A Prospective, Open-Label, Single-Arm Phase II Clinical Trial to Explore Chemotherapy Exemption in Elderly Women Aged 65 Years or Older With Lymph Node-Positive ER+/HER2- Breast Cancer
Acronym: ELDER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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