Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03983096
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
CSPC Ouyi Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

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

Condition or disease
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).

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1050 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Pegylated Liposomal Doxorubicin or Epirubicin in Neoadjuvant or Adjuvant Chemotherapy for Breast Cancer: an Real-world, Multicenter, Case Control Study.
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.



Primary Outcome Measures :
  1. Pathological complete remission (pCR) [ Time Frame: one year ]
    pCR was defned as no invasive cancer cells in any slices of the resected breast specimen.

  2. Disease-free survival (DFS) [ Time Frame: three years. ]
    The length of time after treatment during which no disease in found.


Secondary Outcome Measures :
  1. Adverse event [ Time Frame: three years ]
    Safety was assessed according to Common Terminology Criteria for Adverse Events version 4.0.

  2. Breast conserving rate [ Time Frame: one year ]
    Breast conserving operation rate.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983096


Contacts
Layout table for location contacts
Contact: Jin Zhang, Pro. 86-022-23340123 ext 2901 zhangjin@tjmuch.com

Locations
Layout table for location information
China
Jin Zhang Recruiting
Tianjin, China, 300000
Contact: Jin Zhang, Pro.    86-022-23340123 ext 2901    zhangjin@tjmuch.com   
Sub-Investigator: Jin Zhang, Pro.         
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
CSPC Ouyi Pharmaceutical Co., Ltd.
Investigators
Layout table for investigator information
Study Chair: Jin Zhang, Pro. Tianjin Medical University Cancer Institute and Hospital

Layout table for additonal information
Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT03983096     History of Changes
Other Study ID Numbers: CSPC-DMS-BC-13
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
invasive breast cancer
neoadjuvant
adjuvant
Anthracycline

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
Liposomal doxorubicin
Epirubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action