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

NCT03983096 | Completed

• 1 other identifier: CSPC-DMS-BC-13
• Study Type: observational
• Target: 1,213
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

invasive breast cancer; neoadjuvant; adjuvant; Anthracycline

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Adverse event

  three years

• Breast conserving rate

  one year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Jin Zhang

Tianjin, 300000, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jin Zhang, Pro.

  Tianjin Medical University Cancer Institute and Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 12, 2019
• Study Start: July 7, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: July 8, 2020

Record last verified: 2019-06

Locations

CN (1)