Breast Cancer
Conditions
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.
Interventions
DRUGPegylated Liposomal Doxorubicin and docetaxel
Sponsors
Hebei Medical University Fourth Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PCR rate | 12 months | pathologic complete response rate |
Countries
China
Outcome results
None listed