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

Study Overview
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Brief Summary
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Pegylated liposomal doxorubicin or epirubicin in neoadjuvant or adjuvant chemotherapy for breast cancer.

Detailed Description
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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).

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

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| test group<br>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. That used Pegylated liposomal doxorubicin for treat. | |
| control group<br>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. That used epirubicin for treat. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological complete remission (pCR) | pCR was defned as no invasive cancer cells in any slices of the resected breast specimen. | one year | 
| Disease-free survival （DFS） | The length of time after treatment during which no disease in found. | three years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event | Safety was assessed according to Common Terminology Criteria for Adverse Events version 4.0. | three years | 
| Breast conserving rate | Breast conserving operation rate. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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invasive breast cancer, neoadjuvant, adjuvant, Anthracycline