Comparative Analysis of the Efficacies in Neoadjuvant Chemotherapy of Breast Cancer

307 Hospital of PLA104 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

104

Conditions

Breast Neoplasms

Interventions

PirarubicinDRUG

DocetaxelDRUG

CyclophosphamideDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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%.

Locations (5)

The fourth hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Hunan Provincial People's Hospital

Changsha, Hunan, China

Xiangya Hospital, Central South University

Changsha, Hunan, China

Outcomes

Primary Outcomes

pathological complete response rate

Time frame: one year

Secondary Outcomes

clinical response rate

Time frame: one year

Percentage of changes in hormone receptors status after treatment

Time frame: one year

Number of relative prognostic factors which influence pCR

Time frame: three years

Data from ClinicalTrials.gov

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