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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03983096
• Other study ID #: CSPC-DMS-BC-13
• Status: Completed
• Start date: July 7, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: June 2019
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1213
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
China	Jin Zhang	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital	CSPC Ouyi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete remission (pCR)	pCR was defned as no invasive cancer cells in any slices of the resected breast specimen.	one year
Primary	Disease-free survival (DFS)	The length of time after treatment during which no disease in found.	three years.
Secondary	Adverse event	Safety was assessed according to Common Terminology Criteria for Adverse Events version 4.0.	three years
Secondary	Breast conserving rate	Breast conserving operation rate.	one year