Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05731258
Collaborator
(none)
150
1
125
1.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Liposomal doxorubicin containing regimen

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Clinical Observational Study of Postoperative Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2027
Anticipated Study Completion Date :
Oct 1, 2032

Outcome Measures

Primary Outcome Measures

  1. Cardiac safety [10 years]

    Cardiac ejection fraction

Secondary Outcome Measures

  1. Overall survival [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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;

  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Second Affiliate Hospital of Zhejiang University Hangzhou Zhejiang China 310009

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05731258
Other Study ID Numbers:
  • 2022-0239
First Posted:
Feb 16, 2023
Last Update Posted:
Feb 16, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2023