Chemotherapy Exemption in Elderly Women With Node-Positive ER+/HER2- Breast Cancer (ELDER)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Adjuvant Therapy
• Intervention / Treatment: Drug: CDK4/6 inhibitor; Drug: Endocrine Therapy (Optional)

• Study Type: Interventional
• Enrollment (Estimated): 494
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhimin shao, MD, PhD; Phone Number: +86-021-64175590; Email: zhi_ming_shao@163.com
• Study Contact Backup: Name: jianjing hou; Email: zhi_ming_shao@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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:

1. ≥4 positive lymph nodes
2. 1-3 positive lymph nodes plus at least one of the following high-risk features: i. High-risk multigene assay result ii. Primary tumor size >2 cm iii. Histologic grade 3 iv. Lymphovascular invasion (LVI) positive v. Ki-67 >20% 3. Treatment Acceptance: Willing to receive adjuvant CDK4/6 inhibitor therapy. 4. Performance Status: ECOG score 0-2. 5. Adequate Organ Function:

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:

• Patients who have received neoadjuvant therapy (including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy).

  2. Bilateral breast cancer. 3. History of other malignancies, except: Cured basal cell carcinoma of the skin； Carcinoma in situ of the cervix 4. Distant metastasis (any site). 5. Any T4 lesion (UICC 1987 TNM staging), including: Skin invasion; Fixed mass adherence; Inflammatory breast cancer 6. Concurrent participation in other clinical trials. 7. Severe organ dysfunction (cardiac, pulmonary, hepatic, or renal), including:

  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.

  11. Patients deemed ineligible by investigator assessment. 12. Refusal to receive adjuvant CDK4/6 inhibitor therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chemo-free; A chemotherapy-sparing approach using CDK4/6 inhibitor combined with aromatase inhibitor (minimum 5-year duration).	Drug: CDK4/6 inhibitor; (abemaciclib/ribociclib/dalpiciclib/palbociclib); Drug: Endocrine Therapy (Optional); Endocrine therapy (letrozole/anastrozole/exemestane)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-years Invasive disease free survival	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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from randomisation until the date of death due to any cause.	Approximately 5 years
Clinical Frailty Scale	Clinical Frailty Scale (CFS, version 2.0)	Up to approximately 3 years
Safety including adverse events (AEs), severe adverse events (SAEs) and adverse events of special interest (AESI).	ncidence of AEs, SAE, AESIs (interstitial lung disease, LVEF decrease), AEs resulting in study intervention interruption and discontinuation, etc.	Up to approximately 3 years
Geriatric assessment (G-8)	Modified Geriatric-8 (G-8) screening tool	Up to approximately 3 years

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: zhiming shao, Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): September 30, 2031
• Study Completion (Estimated): October 1, 2035

Study Registration Dates

• First Submitted: September 12, 2026
• First Submitted That Met QC Criteria: September 12, 2026
• First Posted (Actual): September 17, 2026

Study Record Updates

• Last Update Posted (Actual): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 12, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: SCHBCC-N0120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No