Observing the effects of liposomal doxorubicin in breast cancer treatment

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

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.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy, doxorubicin
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05731258 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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

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

Eligibility 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 this trial is running

Hangzhou, Zhejiang

• Second Affiliate Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Xiaochen Wang, Dr.

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