Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen

NCT05731258 | Recruiting FDA Drug

• 1 other identifier: 2022-0239
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Cardiac safety

  Cardiac ejection fraction

  10 years

Secondary Outcomes (1)

• Overall survival

  10 years

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Second Affiliate Hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Xiaochen Wang, Dr.

CONTACT

+86 13958161286; wangxiaochen@zju.edu.cn

Shizhen Zhang, Dr.

CONTACT

+86 15168338547; zhangshizhen@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 16, 2023
• Study Start: May 1, 2022
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2032
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

CN (1)