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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Pegylated Liposomal Doxorubicin and docetaxel

• Registration Number: NCT03221881
• Lead Sponsor: Hebei Medical University Fourth Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Status Verified: 2017-01
• Primary Completion: 2017-04
• Study Completion: 2017-06
• Study First Submitted: 2017-06-22
• Study First Submitted QC: 2017-07-15
• Last Update Submitted: 2017-07-15
• Study First Posted: 2017-07-19
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pegylated Liposomal Doxorubicin and docetaxel	Pegylated Liposomal Doxorubicin and docetaxel	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.

Primary Outcome Measures

Name	Time	Method
PCR rate	12 months	pathologic complete response rate

Trial Locations

Locations (1)

MRI; 🇨🇳 Beijing, Beijing, China