Comparative Analysis of the Efficacies in Neoadjuvant Chemotherapy of Breast Cancer
- Conditions
- Breast Neoplasms
- Interventions
- Registration Number
- NCT02613026
- Lead Sponsor
- 307 Hospital of PLA
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 104
- 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.
- 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%.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combined therapy group Pirarubicin pirarubicin 50mg/m2, iv, d1; docetaxel 75mg/m2, div, d1. 21 days were a cycle of treatment, with a total of 4-8 cycles. Combined therapy group Docetaxel pirarubicin 50mg/m2, iv, d1; docetaxel 75mg/m2, div, d1. 21 days were a cycle of treatment, with a total of 4-8 cycles. Sequential therapy group Pirarubicin cyclophosphamide 600mg/m2, iv, d1; Pirarubicin 60mg/m2, iv, d1, 21 days were a cycle of treatment, with a total of 4 cycles. Then followed by Docetaxel 75- 100mg/m2, div, d1, 21 days were a cycle of treatment, with a total of 4 cycles. Sequential therapy group Cyclophosphamide cyclophosphamide 600mg/m2, iv, d1; Pirarubicin 60mg/m2, iv, d1, 21 days were a cycle of treatment, with a total of 4 cycles. Then followed by Docetaxel 75- 100mg/m2, div, d1, 21 days were a cycle of treatment, with a total of 4 cycles. Sequential therapy group Docetaxel cyclophosphamide 600mg/m2, iv, d1; Pirarubicin 60mg/m2, iv, d1, 21 days were a cycle of treatment, with a total of 4 cycles. Then followed by Docetaxel 75- 100mg/m2, div, d1, 21 days were a cycle of treatment, with a total of 4 cycles.
- Primary Outcome Measures
Name Time Method pathological complete response rate one year
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (5)
The fourth hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Hunan Provincial People's Hospital
🇨🇳Changsha, Hunan, China
Xiangya Hospital, Central South University
🇨🇳Changsha, Hunan, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China