Locally advanced and/or metastatic breast cancer
Conditions
Interventions
Group A:paclitide, powder injection, 300mg/m2, intravenously guttae, every 21 days until disease progression.
Group B:paclitaxel, powder injection, 175mg/m2, intravenously guttae, every 21 days until disease progression. (with standard premedication)
Sponsors
Hefei Anderson Pharmacy Ltd.
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Female aged 18 to 75 years old; 2.Karnofsky >=70; 3.Confirmed pathologic diagnosis of locally advanced and/or metastatic breast cancer; 4.At least 1 target lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines; and no prior radiation on target lesion (except for new target lesion in radiation field); 5.=10.0 g/dL (100g/L) (1) Absolute neutrophil count (ANC):>=1.5*10^9/L; (2) Platelet count: >=100*10^9/L (100,000/mm3); (3) Blood Urea Nitrogen: =3 months.
Exclusion criteria
Exclusion criteria: 1. Presence of clinically significant disease, including significant heart disease, cerebrovascular disease, and uncontrolled diabetes, hypertension, inflammation, active peptic ulcer, etc.; 2. uncontrolled active brain metastasis; 3. Subjects with no measurable disease; 4. Pregnant or breastfeeding women; 5. Other experimental drug treatment within 4 weeks before treatment day 1; 6. Presence of refractory mental disorder or communicable disease; 7. Allergic to taxanes, aminoglutaminic acid (Glu); 8. Hypersensitiveness; 9. Considered not suitable for this clinical trial by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR), Disease Control Rate (DCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary measurement: Progression Free Survival (PFS), Time to Treatment Failure (TTF), Duration of release (DR); | — |
Countries
China
Contacts
Public ContactChengju Zhu
Outcome results
None listed