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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT03983096
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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).

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-10
• Study First Posted: 2019-06-12
• Study Start: 2019-07-07
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Last Update Submitted: 2020-07-05
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1213

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Breast conserving rate	one year	Breast conserving operation rate.
Adverse event	three years	Safety was assessed according to Common Terminology Criteria for Adverse Events version 4.0.

Trial Locations

Locations (1)

Jin Zhang; 🇨🇳 Tianjin, China