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

NCT ID: NCT03221881

Last Updated: 2017-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-06-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pegylated Liposomal Doxorubicin and docetaxel

Intervention Type: DRUG

Interventions

Pegylated Liposomal Doxorubicin and docetaxel

Intervention Type: DRUG

Other Intervention Names

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.

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shan Baoen

Role: PRINCIPAL_INVESTIGATOR

Investigator

Locations

MRI

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CSPC-DMS-BC-01

Identifier Type: -

Identifier Source: org_study_id