Clinical trial · Interventional
Chemotherapy Exemption in Elderly Women With Node-Positive ER+/HER2- Breast Cancer
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
NCT07826052CI-TRIAL-00126388ELDERnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Therapy | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CDK4/6 inhibitor | Drug | — | UNRESOLVED |
| Endocrine Therapy (Optional) | Drug | Hormone Therapy | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemo-free
- description
- A chemotherapy-sparing approach using CDK4/6 inhibitor combined with aromatase inhibitor (minimum 5-year duration).
- interventionNames
- Drug: CDK4/6 inhibitor
- Drug: Endocrine Therapy (Optional)
Primary outcomes (1)
- measure
- 5-years Invasive disease free survival
- timeFrame
- 5 years
- description
- 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.
Secondary outcomes (4)
- measure
- Overall Survival (OS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.