Comparative Analysis of the Efficacies in Neoadjuvant Chemotherapy of Breast Cancer

307 Hospital of PLA

Status and phase: Completed; Phase 3

Conditions: Breast Neoplasms

Treatments: Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Pirarubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT02613026

AT2009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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%.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Combined therapy group

Experimental group

Description:

pirarubicin 50mg/m2, iv, d1; docetaxel 75mg/m2, div, d1. 21 days were a cycle of treatment, with a total of 4-8 cycles.

Treatment:

Drug: Docetaxel

Drug: Pirarubicin

Sequential therapy group

Experimental group

Description:

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.

Treatment:

Drug: Docetaxel

Drug: Pirarubicin

Drug: Cyclophosphamide