Breast Cancer Clinical Trial
Official title:
The Effectiveness and Safety of Neoadjuvant Pegylated Liposomal Doxorubicin and Docetaxel in Breast Cancer.
Verified date | January 2017 |
Source | Hebei Medical University Fourth Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | June 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
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 de?ned 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; |
Country | Name | City | State |
---|---|---|---|
China | MRI | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Hebei Medical University Fourth Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PCR rate | pathologic complete response rate | 12 months |
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