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NCT Number: NCT05731258

Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female, aged 18-75 years;
  • Primary breast cancer diagnosed histopathologically;
  • Adjuvant chemotherapy regimens include liposomal doxorubicin;
  • ECoG PS score: 0-1 points;
  • Left ventricular ejection fraction (LVEF) ≥ 55%;
  • Estimated survival ≥ 6 months;
  • 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;

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

Exclusion criteria

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

Treatment and study plan

Liposomal doxorubicin containing regimen

Drug

Liposomal doxorubicin hydrochloride (PLD) 30-40mg/m2 D1 + other drugs (decided by investigators); All patients were treated with 4 cycles.

Primary outcomes

  1. Cardiac safety

    Time frame: 10 years

    Cardiac ejection fraction

Secondary outcomes

  1. Overall survival

    Time frame: 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Shizhen Zhang, Dr.

CONTACT

[email protected]

+86 15168338547

Xiaochen Wang, Dr.

CONTACT

[email protected]

+86 13958161286

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Clinical Observational Study of Postoperative Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen

Important dates

Study start
2022
Primary completion
2027
Study completion
2032
First posted
Feb 16, 2023
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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