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出境医 / 临床实验 / 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.

Study Description
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).
Study Design
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Study Type : Observational
Actual Enrollment : 1213 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.
Actual Study Start Date : July 7, 2019
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 1, 2020
Arms 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.
Outcome Measures
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.


Eligibility Criteria
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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.
Contacts and Locations

Locations
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China
Jin Zhang
Tianjin, China, 300000
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
CSPC Ouyi Pharmaceutical Co., Ltd.
Investigators
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Study Chair: Jin Zhang, Pro. Tianjin Medical University Cancer Institute and Hospital
Tracking Information
First Submitted Date June 10, 2019
First Posted Date June 12, 2019
Last Update Posted Date July 8, 2020
Actual Study Start Date July 7, 2019
Actual Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 10, 2019)
  • Pathological complete remission (pCR) [ Time Frame: one year ]
    pCR was defned as no invasive cancer cells in any slices of the resected breast specimen.
  • Disease-free survival （DFS） [ Time Frame: three years. ]
    The length of time after treatment during which no disease in found.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 10, 2019)
  • Adverse event [ Time Frame: three years ]
    Safety was assessed according to Common Terminology Criteria for Adverse Events version 4.0.
  • Breast conserving rate [ Time Frame: one year ]
    Breast conserving operation rate.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pegylated Liposomal Doxorubicin or Epirubicin in Neoadjuvant or Adjuvant Chemotherapy for Breast Cancer.
Official Title Pegylated Liposomal Doxorubicin or Epirubicin in Neoadjuvant or Adjuvant Chemotherapy for Breast Cancer: an Real-world, Multicenter, Case Control Study.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 5, 2020) 		1213
Original Estimated Enrollment
 (submitted: June 10, 2019) 		1050
Actual Study Completion Date May 1, 2020
Actual Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03983096
Other Study ID Numbers CSPC-DMS-BC-13
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Tianjin Medical University Cancer Institute and Hospital
Study Sponsor Tianjin Medical University Cancer Institute and Hospital
Collaborators CSPC Ouyi Pharmaceutical Co., Ltd.
Investigators
Study Chair: Jin Zhang, Pro. Tianjin Medical University Cancer Institute and Hospital
PRS Account Tianjin Medical University Cancer Institute and Hospital
Verification Date June 2019

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