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Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen

Recruiting
18 - 75 years of age
Female
Phase N/A

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Overview

The goal of this observational study aims to observe and evaluate the efficacy and safety of a liposomal doxorubicin containing regimen in the postoperative adjuvant treatment of breast cancer patients.

Eligibility

Inclusion Criteria:

  1. Female, aged 18-75 years;
  2. Primary breast cancer diagnosed histopathologically;
  3. Adjuvant chemotherapy regimens include liposomal doxorubicin;
  4. ECoG PS score: 0-1 points;
  5. Left ventricular ejection fraction (LVEF) ≥ 55%;
  6. Estimated survival ≥ 6 months;
  7. Major organ function is normal, i.e. meets the following criteria:

    ① And white blood cells ≥ 4.0 × 10 9 / L, neutrophil count (ANC) ≥ 1.5 × 10 9 /L;② Platelets ≥ 100 × 10 9 /L;③ And hemoglobin ≥ 10 g / dl; ④ Serum creatinine ≤ 1.5 × ⑤ the upper limit of normal (ULN) Mmol / L and aspartate transaminase (AST) ≤ 2.5

    × ULN;⑥ Alanine transaminase (ALT) ≤ 2.5 × ULN;⑦ Total bilirubin ≤ 1.5 × ULN;⑧ Serum creatinine ≤ 1.5 × ULN;

  8. Subjects voluntarily join this study, sign the informed consent form, have good compliance and cooperate with follow-up.

Exclusion Criteria:

  1. Pregnant, lactating patients;
  2. Breast cancer has been found to have distant metastasis;
  3. Those with peripheral nervous system disorders caused by the disease or with a history of significant mental disorders and central nervous system disorders;
  4. Those with severe infection or active peptic ulcer requiring treatment;
  5. Allergic to chemotherapy drugs;
  6. Cancer free period less than 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix;
  7. Severe liver disease (e.g., cirrhosis, etc.), renal disease, respiratory disease, or uncontrolled diabetes;
  8. Patients who are participating in other clinical trials or within a month.

Study details

Breast Cancer, Liposomal Doxorubicin, Efficacy, Safety, Postoperative Adjuvant Treatment

NCT05731258

Second Affiliated Hospital, School of Medicine, Zhejiang University

26 January 2024

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