Neoadjuvant Chemotherapy With a Combination of Pegylated Liposomal Doxorubicin (Caelyx®) and Paclitaxel in Breast Cancer

Hebei Medical University

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Pegylated Liposomal Doxorubicin and docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT03221881

CSPC-DMS-BC-01

Details and patient eligibility

About

In this study, PLD, an anthracycline encapsulated in stealth liposomes, which are believed to efficiently deliver the doxorubicin within the tumour mass with less toxicity compared with standard doxorubicin formulation was used. The study aimed to determine whether the combination of PLD-docetaxel would increase tumour response in patients with breast cancer.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with newly diagnosed breast cancer;
2. Age >18 years;
3. Eastern Cooperative Group (ECOG) performance status 0-2;
4. measurable disease (as per radiological imaging); life
5. expectancy >12 months;
6. adequate haematologic blood profile;
7. normal liver and kidney function;
8. adequate cardiac function;
9. no metastatic disease;
10. negative pregnancy test (premenopausal women);
11. signed informed consent.

Exclusion criteria

1. Level 2 cardiac toxic effects were defined as asymptomatic systolic dysfunction (NYHA class I) or mildly symptomatic heart failure (NYHA class II) ;
2. Previous treatment for breast cancer, including surgery, radiation, cytotoxic and endocrine treatments (except surgical diagnostic procedures);
3. Active infection or other serious underlying medical or psychiatric condition which would impair the ability of the patient to receive protocol treatment;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Pegylated Liposomal Doxorubicin and docetaxel

Experimental group

Description:

Pegylated Liposomal Doxorubicin 30-35 mg/m (2) and docetaxel 75-80 mg/m(2) were both administered on day 1,intravenous, Cycles were repeated in 3-week intervals,for 6 cycles.

Treatment:

Drug: Pegylated Liposomal Doxorubicin and docetaxel