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

NCT07005557 | Not Yet Recruiting Phase 3

• 1 other identifier: SCHBCC-N089
• Study Type: interventional
• Target: 1,244
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall Survival (OS)

  Approximately 5 years

• Safety including adverse events (AEs), severe adverse events (SAEs) and adverse events of special interest (AESI).

  Up to approximately 3 years

• Geriatric assessment (G-8)

  Up to approximately 3 years

• Clinical Frailty Scale

  Up to approximately 3 years

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Drug: Chemotherapy; Drug: CDK4/6 Inhibitor; Drug: Endocrine therapy

Chemo-free

EXPERIMENTAL

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

Drug: CDK4/6 Inhibitor; Drug: Endocrine therapy

Interventions

Chemotherapy DRUG

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

Control

CDK4/6 Inhibitor DRUG

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

Chemo-free; Control

Endocrine therapy DRUG

Endocrine therapy (letrozole/anastrozole/exemestane)

Chemo-free; Control

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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:
• ≥4 positive lymph nodes
• 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.

You may not qualify if:

• \. Patients who have received neoadjuvant therapy (including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy).
• \. 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.
• \. Patients deemed ineligible by investigator assessment. 12. Refusal to receive adjuvant CDK4/6 inhibitor therapy.

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Zhiming Shao

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhimin Shao, MD, PhD

CONTACT

+86-021-64175590; zhi_ming_shao@163.com

Peng Ji

CONTACT

zhi_ming_shao@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of General Surgery of Fudan Shanghai Cancer Center

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: June 5, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): May 15, 2030
• Study Completion (Estimated): May 15, 2035
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share