Breast Cancer
Conditions
Interventions
Experimental group:Everolimus (10 mg/ day, Po) combined with EC (famacin 90mg/m2 iv d1+ cyclophosphamide 600mg/m2 iv d1, 21 days in a cycle) 4 cycles followed by T (docetaxel 100mg/m2, iv, d1, 21 days
Control group : EC (famacin 90mg/m2 iv d1+ cyclophosphamide 600mg/m2 iv d1, 21 days in a cycle) 4 cycles followed by T (docetaxel 100mg/m2, iv, d1, 21 days in a cycle) 4 cycles
Sponsors
SUN YAT-SEN MEMORIAL HOSPITAL, SYSU
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent; 2. No distant metastasis by histological diagnosis of histological grade level III of invasive breast cancer patients (T > 2 cm, or any T and histological diagnosis of metastatic axillary lymph node > 2 cm), tumor molecular diagnosis of ER positive immunohistochemical study (ER positive percentage of 10% or higher), her2-negative (HER2 immunohistochemical staining 0 or 1 + or fluorescence in situ hybridization FISH -); 3. Tumor puncture immunohistochemical staining confirmed high expression of BARD1 (according to SI score, SI= staining intensity (no staining: 0, light brown: 1, brown: 2, dark brown :3) * positive percentage (50%:3), SI 4 is high expression); 4. No previous chemotherapy, endocrine therapy, surgery or radiotherapy; 5. Cardiac color ultrasound indicated that cardiac ejection fraction was within the normal range; 6. Score 0-2 on the ECOG scale; 7. Female patients aged 18-70 years; 8. Can swallow pills; 9. The organ functions are good and meet the following indexes: Hb = 90 g/L; WBC = 3.5 x 10^9 / L; Platelet = 100 x 10^9 / L; Neutrophils = 1.5 x 10^9/L; Cereal straw transaminase does not exceed 3 times normal upper limit; Alanine aminotransferase is no more than 3 times the normal upper limit; Bilirubin is not greater than 1.5 times the normal upper limit; Serum creatinine should not exceed 1.5 times the normal upper limit.
Exclusion criteria
Exclusion criteria: 1. Combined with other malignant tumors or had malignant tumors other than breast cancer in the past 5 years, except for cutaneous basal cell carcinoma, squamous cell carcinoma and cervical carcinoma in situ that have been fully treated and controlled; 2. Patients with active infection are not suitable for chemotherapy; 3. Serious diseases associated with non-malignant tumors will affect the patient's compliance or put the patient in a dangerous state; 4. Accompanying other anti-tumor treatments or participating in other clinical trials; 5. Bilateral or inflammatory breast cancer; 6. Dementia, mental abnormalities or any mental illness that interferes with the understanding of informed consent; 7. Have received any mTOR inhibitor drugs in the past; 8. History of anaphylaxis or contraindications to any of the tested drug ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission ; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;breast conservation rate ;adverse reaction rate ;5 year disease-free survival ;5 year overall survival ; | — |
Countries
China
Contacts
Public ContactQiang Liu
BREAST TUMOR CENTER, SUN YAT-SEN MEMORIAL HOSPITAL, SYSU
Outcome results
None listed