Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen

Clinical Observational Study of Postoperative 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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Efficacy; Safety; Liposomal Doxorubicin; Postoperative Adjuvant Treatment
• Intervention / Treatment: Drug: Liposomal doxorubicin containing regimen

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Xiaochen Wang, Dr.; Phone Number: +86 13958161286; Email: wangxiaochen@zju.edu.cn
• Study Contact Backup: Name: Shizhen Zhang, Dr.; Phone Number: +86 15168338547; Email: zhangshizhen@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affiliate Hospital of Zhejiang University
      • Contact: Xiaochen Wang, Dr.; Phone Number: +86 13958161286; Email: wangxiaochen@zju.edu.cn
      • Contact: Shizhen Zhang, Dr.; Phone Number: +86 15168338547; Email: zhangshizhen@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac safety	Cardiac ejection fraction	10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	10 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): October 1, 2027
• Study Completion (Anticipated): October 1, 2032

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Doxorubicin; Liposomal doxorubicin
• Other Study ID Numbers: 2022-0239

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No