Comparative Analysis of the Efficacies in Neoadjuvant Chemotherapy of Breast Cancer

November 22, 2015 updated by: Shikai Wu, 307 Hospital of PLA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050010
        • The Fourth Hospital of Hebei Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Harbin Medical University Cancer Hospital
    • Hunan
      • Changsha, Hunan, China, 410005
        • Hunan Provincial People's Hospital
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital, Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Jiangsu Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combined therapy group
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: Docetaxel
Other Names:
  • Taxotere
Drug: Pirarubicin
Other Names:
  • Tetrahydropyranyl Adriamycin
Experimental: Sequential therapy group
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: Docetaxel
Other Names:
  • Taxotere
Drug: Cyclophosphamide
Drug: Pirarubicin
Other Names:
  • Tetrahydropyranyl Adriamycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pathological complete response rate
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical response rate
Time Frame: one year
one year
Percentage of changes in hormone receptors status after treatment
Time Frame: one year
one year
Number of relative prognostic factors which influence pCR
Time Frame: three years
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

307 Hospital of PLA

Investigators

  • Principal Investigator: Shikai Wu, 307 Hospital of PLA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

November 3, 2015

First Submitted That Met QC Criteria

November 22, 2015

First Posted (Estimate)

November 24, 2015

Study Record Updates

Last Update Posted (Estimate)

November 24, 2015

Last Update Submitted That Met QC Criteria

November 22, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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