Breast Neoplasms
Conditions
Keywords
Breast tumor, Neoadjuvant chemotherapy, Pathological complete remission
Brief summary
The purpose of this study is to compare the short-term and long-term efficacies and the safeties of pirarubicin plus docetaxel(AT group) and pirarubicin plus cyclophosphamide followed by docetaxel(AC-T group) in neoadjuvant chemotherapy of breast cancer.
Detailed description
Based on the results of NSABP(National Surgical Adjuvant Breast and Bowel Project) B27 trial, anthracyclines(A) and Taxanes(T) are most commonly recommended in neoadjuvant chemotherapy of breast cancer. Pirarubicin is one of anthracyclines and by embedding the DNA double stranded, which inhibits DNA replication and RNA synthesis, thereby impedes the rapid growth of cancer cells. Docetaxel in one of taxanes and by strengthening the tubulin polymerization, inhibiting of microtubule depolymerization and leading to the formation of stable non functional microtubule bundles, which destroys mitosis of tumor cells.
Interventions
Sponsors
307 Hospital of PLA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* histopathologically diagnosed with stage I-III breast cancers; * clearly confirmed ER, PR and HER2 statuses; * the state of axillary lymph nodes was determined through the relevant examination steps (puncture or sentinel lymph node biopsy); * the patients were not treated with neoadjuvant therapy and surgery.
Exclusion criteria
* the patients whose breasts or axillary lumps had received excision biopsy; * the patients who had severely abnormal organ functions or who could not tolerate chemotherapy, * the patients with severe concomitant diseases; * the patients with heart disease or left ventricular ejection fraction (LVEF) \<50%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate | one year |
Secondary
| Measure | Time frame |
|---|---|
| clinical response rate | one year |
| Percentage of changes in hormone receptors status after treatment | one year |
| Number of relative prognostic factors which influence pCR | three years |
Countries
China
Outcome results
None listed