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Completed

NCT Number: NCT02613026

Comparative Analysis of the Efficacies 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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

The fourth hospital of Hebei Medical University, Shijiazhuang, Hebei, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

pirarubicin

Drug

Other names: Tetrahydropyranyl Adriamycin

docetaxel

Drug

Other names: Taxotere

Cyclophosphamide

Drug

Primary outcomes

  1. pathological complete response rate

    Time frame: one year

Secondary outcomes

  1. clinical response rate

    Time frame: one year

  2. Percentage of changes in hormone receptors status after treatment

    Time frame: one year

  3. Number of relative prognostic factors which influence pCR

    Time frame: three years

Sponsors and collaborators

Lead sponsor

307 Hospital of PLA

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2015
First posted
Nov 24, 2015
Registry last updated
Nov 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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