Breast Cancer
Conditions
Interventions
Sponsors
Tumor Hospital of YunNan Province
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Female, aged >= 18 years; 2.Eastern Cooperative Oncology Group (ECOG) score 0-1; 3.Histologically diagnosed as unilateral or bilateral primary infiltrating carcinoma of the breast female; Estrogen Receptor positive and/or Progesterone Receptor positive Fluorescence in Situ Hybridization (Fish) confirm tested: negative (No amplification); Estrogen receptor immunohistochemistry (IHC) tumor staining >1% Progesterone receptor IHC tumor staining >1% Her2/neu fluorescence in situ hybridization (FISH) ratio < 1.8 or IHC 0 or 1+ 4.Patients with T1c, N1-N2/T2, N0-N2/T3, N0-N2/T4a-d, N0-N2 per current American Joint Committee of Cancer (AJCC) staging criteria for breast cancer by the investigator based on radiological and/or clinical assessment. 5.Normative neoadjuvant chemotherapy according NCCN guideline ,include anthracyclines and taxanes undergo treatment. 6.Modified radical mastectomy or breast-conserving mastectomy. 7.Residual invasive disease in the breast or axillary lymph nodes after neoadjuvant therapy through evaluation of postoperation pathology. 8.Postoperative treatment should be provided adequate adjuvant chemotherapy or endocrine therapy.
Exclusion criteria
Exclusion criteria: 1.Any active malignancy <= 2 years, except for basal cell or squamous cell skin cancer, cervical or breast carcinoma in situ that has undergone potentially curative surgery. 2.Any distant metastasis. 3.Patients with in situ carcinoma reaching pCR and pN0 after NAC. 4.Patients with previous malignant tumors. 5.Develop a second primary cancer at least two months after the breast cancer diagnosis. 6.Patients with Renal dysfunctionActive mental system diseases (schizophrenia, severe depressive disorder, bipolar disorder, etc.). 7.Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study. 8.active connective tissue disease, such as scleroderma, systemic lupus erythematosus or collagen vascular disease; 9.unwilling to sign the informed consent. 10.persons without full capacity for civil conduct. 11.Other conditions which, in the opinion of the investigator, make them unsuitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS; | — |
Countries
China
Contacts
Public ContactWenlin Chen
Tumor Hospital of Yunnan Province
Outcome results
None listed