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: an Real-world, Multicenter, Case Control Study.

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

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 1213

Contacts and Locations

Study Locations

• China
  • Tianjin, China, 300000
    • Jin Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

A total of 1050 breast cancer patients were collected from seven centers. 200 cases in neoadjuvant and 850 cases in adjuvant group.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: CSPC Ouyi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 7, 2019
• Primary Completion (ACTUAL): May 1, 2020
• Study Completion (ACTUAL): May 1, 2020

Study Registration Dates

• First Submitted: June 10, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (ACTUAL): June 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 5, 2020
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: neoadjuvant; adjuvant; Anthracycline; invasive breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CSPC-DMS-BC-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No