Chemo-free in Older (≥65) Node-Positive ER+/HER2- Breast Cancer

NCT ID: NCT07005557

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2035-05-15

Brief Summary

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.

Conditions

Breast Cancer; Adjuvant Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Chemotherapy, endocrine therapy, or CDK4/6 inhibitors, administered at the physician's discretion.

Group Type: ACTIVE_COMPARATOR

Chemotherapy

Intervention Type: DRUG

Chemotherapy options at physician's discretion: TC, EC-T(wP), or capecitabine.

CDK4/6 Inhibitor

Intervention Type: DRUG

All patients will receive CDK4/6 inhibitor (abemaciclib/ribociclib/dalpiciclib/palbociclib)

Endocrine therapy

Intervention Type: DRUG

Endocrine therapy (letrozole/anastrozole/exemestane)

Chemo-free

A chemotherapy-sparing approach using CDK4/6 inhibitor combined with aromatase inhibitor (minimum 5-year duration).

Group Type: EXPERIMENTAL

CDK4/6 Inhibitor

Intervention Type: DRUG

All patients will receive CDK4/6 inhibitor (abemaciclib/ribociclib/dalpiciclib/palbociclib)

Endocrine therapy

Intervention Type: DRUG

Endocrine therapy (letrozole/anastrozole/exemestane)

Interventions

Chemotherapy

Chemotherapy options at physician's discretion: TC, EC-T(wP), or capecitabine.

Intervention Type: DRUG

CDK4/6 Inhibitor

All patients will receive CDK4/6 inhibitor (abemaciclib/ribociclib/dalpiciclib/palbociclib)

Intervention Type: DRUG

Endocrine therapy

Endocrine therapy (letrozole/anastrozole/exemestane)

Intervention Type: DRUG

Eligibility Criteria

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

• 1. 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhimin Shao

Director of General Surgery of Fudan Shanghai Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhiming Shao

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Central Contacts

Zhimin Shao, MD, PhD

Role: CONTACT

zhi_ming_shao@163.com

+86-021-64175590

Peng Ji

Role: CONTACT

zhi_ming_shao@163.com

Other Identifiers

SCHBCC-N089

Identifier Type: -

Identifier Source: org_study_id