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RecruitingNCT05731258Updated Feb 16, 2023

Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen

An observational study in Breast Cancer, Liposomal Doxorubicin and Efficacy, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-02-16.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

From the registry’s dates

  • Started May 2022; still recruiting 4 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
150
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

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

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03

In context

Breast Neoplasms

12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 150 is below the median of 184 across 2,643 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Early breast cancer patients who required four cycles of chemotherapy after curative resection of breast cancer

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
150 participants (estimated)
Patient registry
No

Interventions

  • DrugLiposomal doxorubicin containing regimen

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

06

What researchers measure

Primary outcomes

  1. Cardiac safety

    Cardiac ejection fraction

    Time frame: 10 years

Secondary outcomes

  1. Overall survival

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • Second Affiliate Hospital of Zhejiang University
    Hangzhou, Zhejiang 310009, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05731258
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Feb 16, 2023
Start date
May 1, 2022
Primary completion
Oct 2027 (estimated)
Completion
Oct 2032 (estimated)
Last update
Feb 16, 2023

Study contacts

Xiaochen Wang, Dr.
Contact
wangxiaochen@zju.edu.cn
+86 13958161286
Shizhen Zhang, Dr.
Contact
zhangshizhen@zju.edu.cn
+86 15168338547

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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