ER-positive, HER2-negative invasive breast cancer
Conditions
Interventions
Arm A: Standard Treatment (Surgery + Postoperative Therapy)
(1) Surgery
- Breast: Breast-conserving surgery or mastectomy.
- Axilla: Sentinel lymph node biopsy or axillary lymph node dissection.
(2) P
Sponsors
KANEMITSU Yukihide
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histologically diagnosed as invasive breast cancer with ER-positive and HER2-negative. 2. Strong ER expression. 3. Invasive carcinoma >=2 mm on biopsy specimen. 4. Regarding nodal status (N), tumor size (T), and histological grade (HG), one of the following (i) or (ii) applies: (i) If cN0, any of the following (a)-(c): (a) HG 1: 3 cm =18 years. 9. ECOG Performance Status (PS) of 0 or 1. 10. No previous invasive or non-invasive breast cancer. 11. BRCA mutation not confirmed (testing not required). 12. No prior chemotherapy, endocrine therapy, or surgery for breast cancer (except endocrine therapy for menopausal symptoms, biopsy, or sentinel node biopsy). 13. No systemic anticancer therapy (including molecular targeted agents or immune checkpoint inhibitors) for other cancers within the last 5 years. 14. Recent blood tests (within 14 days) meet all of the following:: (i) Neutrophil count >=1,500/mm3 (ii) Hemoglobin >=9.0 g/dL (iii) Platelet count >=100,000/mm3 (iv) Total bilirubin <=1.5 mg/dL (v) AST <=100 U/L (vi) ALT <=100 U/L (vii) Serum creatinine <=1.5 mg/dL 15. Written informed consent obtained.
Exclusion criteria
Exclusion criteria: (1) Synchronous or metachronous (within 5 years) malignancies. (2) Infectious disease requiring systemic treatment. (3) Body temperature of 38 degrees Celsius or higher. (4) Female during pregnancy, within 28 days of postparturition, or during lactation. (5) Severe psychological disorder difficult to participate in this clinical study. (6) Receiving continuous systemic corticosteroid with a prednisolone equivalent greater than 10 mg/day or immunosuppressant treatment. (7) Uncontrollable diabetes mellitus. (8) Uncontrollable hypertension. (9) Unstable angina pectoris, or history of myocardial infarction within 6 months. (10) Uncontrollable valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. (11) HBs antigen positive or HCV antibody positive (12) Pulmonary fibrosis or severe pulmonary emphysema based on chest CT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EFS:event-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Relapse-free survival, Distant metastasis-free survival, Proportion receiving postoperative endocrine therapy alone, Proportion receiving chemotherapy, ET response rate (Arm B), Incidence of adverse events, Incidence of serious adverse events, Non-deterioration proportion in HR-QOL, Proportion remaining premenopausal | — |
Contacts
Public ContactHiroshi KATAYAMA
National Cancer Center Hospital
Outcome results
None listed