Clinical trial · Interventional

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

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

NCT07005557CI-TRIAL-00090646SENIORnot yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

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 (3)

Intervention	Type	Mapped drug	Match
CDK4/6 Inhibitor	Drug	—	UNRESOLVED
Chemotherapy	Drug	Chemotherapy	ALIAS
Endocrine therapy	Drug	Hormone Therapy	ALIAS

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Control
description
Chemotherapy, endocrine therapy, or CDK4/6 inhibitors, administered at the physician's discretion.
interventionNames
1. Drug: Chemotherapy
2. Drug: CDK4/6 Inhibitor
3. Drug: Endocrine therapy
type
EXPERIMENTAL
label
Chemo-free
description
A chemotherapy-sparing approach using CDK4/6 inhibitor combined with aromatase inhibitor (minimum 5-year duration).
interventionNames
1. Drug: CDK4/6 Inhibitor
2. Drug: Endocrine therapy

Primary outcomes (1)

measure
5-years Invasive disease free survival

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:

* 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.

References

Publications (0)

Data not yet available

No reference posted for this study.