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| Name | Class |
|---|---|
| CSPC Ouyi Pharmaceutical Co., Ltd. | INDUSTRY |
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Pegylated liposomal doxorubicin or epirubicin in neoadjuvant or adjuvant chemotherapy for breast cancer.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event | Safety was assessed according to Common Terminology Criteria for Adverse Events version 4.0. | three years |
| Breast conserving rate | Breast conserving operation rate. |
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Inclusion Criteria:
Exclusion Criteria:
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A total of 1050 breast cancer patients were collected from seven centers. 200 cases in neoadjuvant and 850 cases in adjuvant group.
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| Name | Affiliation | Role |
|---|---|---|
| Jin Zhang, Pro. | Tianjin Medical University Cancer Institute and Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jin Zhang | Tianjin | 300000 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| one year |
| D017437 |
| Skin and Connective Tissue Diseases |