Adjuvant Therapy, Breast Cancer
Conditions
Brief summary
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.
Interventions
DRUGCDK4/6 inhibitor
(abemaciclib/ribociclib/dalpiciclib/palbociclib)
Endocrine therapy (letrozole/anastrozole/exemestane)
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-years Invasive disease free survival | 5 years | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Approximately 5 years | OS is defined as the time from randomisation until the date of death due to any cause. |
| Safety including adverse events (AEs), severe adverse events (SAEs) and adverse events of special interest (AESI). | Up to approximately 3 years | ncidence of AEs, SAE, AESIs (interstitial lung disease, LVEF decrease), AEs resulting in study intervention interruption and discontinuation, etc. |
| Geriatric assessment (G-8) | Up to approximately 3 years | Modified Geriatric-8 (G-8) screening tool |
| Clinical Frailty Scale | Up to approximately 3 years | Clinical Frailty Scale (CFS, version 2.0) |
Contacts
CONTACTZhimin shao, MD, PhD
CONTACTjianjing hou
PRINCIPAL_INVESTIGATORzhiming shao
Fudan University
Outcome results
None listed