Breast Cancer
Conditions
Keywords
invasive breast cancer, neoadjuvant, adjuvant, Anthracycline
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).
Interventions
None listed
Sponsors
CSPC Ouyi Pharmaceutical Co., Ltd.
Tianjin Medical University Cancer Institute and Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete remission (pCR) | one year | pCR was defned as no invasive cancer cells in any slices of the resected breast specimen. |
| Disease-free survival （DFS） | three years. | The length of time after treatment during which no disease in found. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event | three years | Safety was assessed according to Common Terminology Criteria for Adverse Events version 4.0. |
| Breast conserving rate | one year | Breast conserving operation rate. |
Countries
China
Outcome results
None listed