Breast cancer
Conditions
Interventions
Intervention group:The chemotherapy regimen was TC regimen. Docetaxel 75 mg / m2 IV D1, cyclophosphamide 600 mg / m2 IV D1, 21d as one cycle for 4 cycles.
Control group:No chemotherapy was administered postoperatively.
Sponsors
Department of Breast Center, West China Hospital of Sichuan University
Eligibility
Sex/Gender
Female
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female, age >= 70 years old, predicted survival greater than 6 months; 2. Invasive breast cancer diagnosed by open needle aspiration or intraoperative and postoperative histopathology (excluding inflammatory breast cancer and intraductal cancer with suspicious or focal or microinvasion); 3. Postoperative medical examination satisfied any of the following: (1) luminal type B (Ki-67 >= 30%); (2) HER-2-positive type; (3) Triple negative type; (4) Postoperative medical examination confirmed axillary lymph node metastasis >= 1 (excluding micrometastasis and solitary tumor cells); 4. No concurrent other malignancy (other than controlled carcinoma in situ of cervix and basal cell carcinoma of skin); 5. Normal bone marrow function, blood routine: neutrophils >= 2.5 × 109 / L, hemoglobin >= 100 g / L, and platelets >= 100 × 109 / L, no coagulopathy; 6. Normal liver and renal function tests: AST = 55%; 8. ECoG score 0-1 points; 9. Willingness to collaborate on postoperative chemotherapy and its associated treatments; 10. Signed informed consent and protocol compliance is good.
Exclusion criteria
Exclusion criteria: 1. Had previously used systemic or local therapy including chemotherapy for breast cancer (except for topical agents); 2. Breast cancer has been found to have distant metastasis; 3. Those who cannot tolerate adjuvant chemotherapy and related treatment: those with uncontrolled lung disease, severe infection, active peptic ulcer requiring treatment, coagulopathic disease, connective tissue disease or myelosuppression; 4. Previous congestive heart failure, uncontrolled or symptomatic angina, arrhythmia or myocardial infarction, difficult to control hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg); 5. Those unwilling to administer postoperative adjuvant chemotherapy; 6. Patients with psychosis or other reasons for nonadherence to treatment; 7. Those with a known history of severe allergy to any of the drugs in the treatment regimen; 8. Had used other chemotherapy drugs for breast cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival;Disease-free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Circulating tumor cell;Postoperative complications;The FRAIL Scale;Montreal Cognitive Assessment;Instrumental activities of daily living scale;mininutritional assessment short form;EORTC(European Organisation for Research and Treatment of Cancer) QLQ(Quality of Life Questions)-BR(Breast)23;EORTC(European Organisation for Research and Treatment of Cancer) QLQ(Quality of Life Questions)-C30; | — |
Countries
China
Contacts
Public ContactJie Chen
West China Hospital of Sichuan University
Outcome results
None listed