Clinical trial NCT03983096: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: invasive breast cancer
neoadjuvant
adjuvant
Anthracycline
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: CSPC Ouyi Pharmaceutical Co., Ltd.
First posted: 2019-06-12
Enrollment: 1213
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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).

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.

Primary outcomes:
measure: Pathological complete remission (pCR)
timeFrame: one year
measure: Disease-free survival （DFS）
timeFrame: three years.
Secondary outcomes:
measure: Adverse event
timeFrame: three years
measure: Breast conserving rate
timeFrame: one year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Jin Zhang
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Jin Zhang, Pro.
role: STUDY_CHAIR
References: