Chemotherapy
DrugChemotherapy options at physician's discretion: TC, EC-T(wP), or capecitabine.
NCT Number: NCT07005557
This study is a prospective, open-label, multicenter, randomized controlled Phase III 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 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-1. Age: Female patients aged ≥65 years. 2. Disease Status: Histologically confirmed early-stage breast cancer after surgery with ER expression ≥50% AND one of the following:
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.
Chemotherapy options at physician's discretion: TC, EC-T(wP), or capecitabine.
All patients will receive CDK4/6 inhibitor (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
Incidence 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
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.
Fudan University
Other
Study Evaluating Node-positive, ER+/HER2- In Older (≥65 Years) Breast Cancer Patients for Chemotherapy Exemption: A Randomized, Open-label, Multicenter Phase III Clinical Trial
Acronym: SENIOR
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.
Published trials that share one or more normalized conditions with this study.
NCT06719206
Adjuvant Therapy, Behavior
Uppsala, Sweden
View Trial DetailsNCT07019363
Adjuvant Therapy, Breast Cancer
Shanghai, China
View Trial DetailsNCT05599334
Adjuvant Therapy, Breast Cancer
Bouge, Belgium
View Trial DetailsNCT05292742
Adjuvant Therapy, Breast Cancer
Fuzhou, Fujian, China
View Trial Details