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Completed

NCT Number: NCT03983096

Pegylated Liposomal Doxorubicin or Epirubicin in Neoadjuvant or Adjuvant Chemotherapy for Breast Cancer.

Pegylated liposomal doxorubicin or epirubicin in neoadjuvant or adjuvant chemotherapy for breast cancer.

Completed

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Jin Zhang

Tianjin, 300000, China

About this study

This study is an real-world, multicenter, case control study about comparing pegylated liposomal doxorubicin Efficacy and safety of epirubicin in neoadjuvant and adjuvant chemotherapy for breast cancer. As this trial is a retrospective real-world study, investigator have given patients the dose of trial drugs based on real-world principles of diagnosis and treatment and their clinical experience. This trial only collects and analyzes patients' clinical medications, and does not interfere with patients' real-world diagnosis and treatment. A total of 1050 breast cancer patients are collecting from seven centers. 200 cases in neoadjuvant and 850 cases in adjuvant group. The follow-up examinations and assessment of the subjects were followed by real-world medical treatment routines and the visits were completed according to the routine of treatment. Related check and assessments and collect the following data: follow-up 3years or until the disease recurs (whichever occurs first). Adverse events: remission or stability of adverse events caused by follow-up to treatment in the adjuvant treatment group, follow-up for 3 years or until recurrence of the disease in the neoadjuvant treatment group (whichever first occurred).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female;
  • Patients with invasive breast cancer diagnosed by menstrual histology in 2014-2018 and receiving neoadjuvant chemotherapy, or patients with invasive breast cancer diagnosed by menstrual histology in 2014-2016 and receiving adjuvant chemotherapy;
  • Chemotherapy regimen recommended by the guidelines for drugs containing anthracycline;
  • Patients whose chemotherapy regimen contains pegylated liposomal doxorubicin or epuroxorubicin;
  • Age :18 -70;
  • Patients with LVEF ≥ 50%.

Exclusion criteria

  • Patients with occult breast cancer.
  • Patients receiving two or more anthracyclines during neoadjuvant or adjuvant chemotherapy;
  • Patients who have previously received other chemotherapy regimens;
  • Patients with other malignant tumors in the past 5 years (except for cured cervical carcinoma in situ and basal cell carcinoma of the skin);
  • Patients complicated with severe infection and in need of treatment;
  • Pregnant or lactating women.

Treatment and study plan

Primary outcomes

  1. Pathological complete remission (pCR)

    Time frame: one year

    pCR was defned as no invasive cancer cells in any slices of the resected breast specimen.

  2. Disease-free survival (DFS)

    Time frame: three years.

    The length of time after treatment during which no disease in found.

Secondary outcomes

  1. Adverse event

    Time frame: three years

    Safety was assessed according to Common Terminology Criteria for Adverse Events version 4.0.

  2. Breast conserving rate

    Time frame: one year

    Breast conserving operation rate.

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

Registry information

Official study title

Pegylated Liposomal Doxorubicin or Epirubicin in Neoadjuvant or Adjuvant Chemotherapy for Breast Cancer: an Real-world, Multicenter, Case Control Study.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 12, 2019
Registry last updated
Jul 8, 2020

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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