Comparative Analysis of the Efficacies in Neoadjuvant Chemotherapy of Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Analysis of the Efficacies of AT and AC-T Regimens in Neoadjuvant Chemotherapy of Breast Cancer

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: Pirarubicin
* Drug: Docetaxel
* Drug: Cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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%.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined therapy group<br>pirarubicin 50mg/m2, iv, d1; docetaxel 75mg/m2, div, d1. 21 days were a cycle of treatment, with a total of 4-8 cycles. | Drug: Pirarubicin<br> <br> * Other names: Tetrahydropyranyl Adriamycin;Drug: Docetaxel<br> <br> * Other names: Taxotere;|
| Experimental: Sequential therapy group<br>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. | Drug: Pirarubicin<br> <br> * Other names: Tetrahydropyranyl Adriamycin;Drug: Docetaxel<br> <br> * Other names: Taxotere;Drug: Cyclophosphamide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological complete response rate |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast tumor, Neoadjuvant chemotherapy, Pathological complete remission