Clinical trial Recruiting at 1 site Observational Ages 18 to 75 Women only

Observing the effects of liposomal doxorubicin in breast cancer treatment

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

Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT05731258 · Data updated 2026-11-12

This study is testing how well liposomal doxorubicin works and how safe it is for women aged 18-75 who are getting treatment after surgery for breast cancer.

More Breast Cancer trials

Quick facts

Study typeObservational
Ages18 Years to 75 Years
SexWomen only
Enrollment150 (estimated)
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine
Academic / other
Drugs / interventionschemotherapy, doxorubicin
Locations1 site (Hangzhou, Zhejiang)
StatusRecruiting
StartedMay 1, 2022
Main results expectedOctober 2027
Study endsOctober 2032
Registry record updatedFebruary 16, 2023
Trial IDNCT05731258 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are females aged 18-75 with histopathologically diagnosed primary breast cancer who are receiving liposomal doxorubicin as part of their adjuvant chemotherapy.

Probably not a fit

Patients with distant metastasis or those who are pregnant or lactating may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the efficacy and safety of a regimen containing liposomal doxorubicin for patients undergoing postoperative adjuvant treatment for breast cancer. It includes female participants aged 18-75 years who have been diagnosed with primary breast cancer and are receiving this specific chemotherapy regimen. The study will monitor various health parameters and patient outcomes to gather data on the treatment's effectiveness and safety profile.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of liposomal doxorubicin, potentially improving treatment options for breast cancer patients.

How similar studies have gone: While this approach is observational, similar studies evaluating liposomal doxorubicin have shown promising results in other contexts.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Second Affiliate Hospital of Zhejiang University
    Hangzhou, Zhejiang, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.