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

NCT ID: NCT03983096

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1213 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-07
• Study Completion Date: 2020-05-01

Brief Summary

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

Detailed 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).

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

test group

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.

No interventions assigned to this group

control group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jin Zhang, Pro.

Role: STUDY_CHAIR

Tianjin Medical University Cancer Institute and Hospital

Locations

Jin Zhang

Tianjin, , China

Countries

China

Other Identifiers

CSPC-DMS-BC-13

Identifier Type: -

Identifier Source: org_study_id