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

Tianjin Medical University

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03983096

CSPC-DMS-BC-13

Details and patient eligibility

About

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

Full description

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).

Enrollment: 1,213 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female;
2. 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;
3. Chemotherapy regimen recommended by the guidelines for drugs containing anthracycline;
4. Patients whose chemotherapy regimen contains pegylated liposomal doxorubicin or epuroxorubicin;
5. Age :18 -70;
6. Patients with LVEF ≥ 50%.

Exclusion criteria

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

Trial design

1,213 participants in 2 patient groups

test group

Description:

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

Description:

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.