Breast Cancer
Conditions
Keywords
Breast cancer, Albumin-bound paclitaxel, paclitaxel/docetaxel-resistant
Brief summary
Albumin-bound Paclitaxel Combination With Capecitabine Versus Capecitabine Monotherapy in Paclitaxel/Docetaxel-resistant Advanced Breast Cancer
Detailed description
A Phase II, single-center, randomized study of albumin-bound paclitaxel combination with capecitabine versus capecitabine monotherapy in paclitaxel/docetaxel-resistant advanced breast cancer.
Interventions
DRUGAlbumin-bound paclitaxel plus capecitabine
Albumin-bound paclitaxel plus capecitabine: Albumin-bound paclitaxel 260mg/m2, IV , D1, q3w； capecitabine 1000 mg/m2, PO，bid, D1-14,q3w.
DRUGcapecitabine
capecitabine: capecitabine 1000 mg/m2, PO，bid, D1-14,q3w.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Females with age between 18 and 70 years old 2. Histological proven unresectable recurrent or advanced breast cancer 3. Negative for human epithelial receptor-2 (HER2) by immunohistochemistry. A negative Her2 gene amplification should be verified by FISH test for those patients with Her2 (2+). For those with Her2 (1+), FISH test might be considered by the investigator. 4. Patients who developed disease progression within 12 months of previous paclitaxel-containing chemotherapy regimens. 5. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1) 6. Performance status no more than 1 7. All patients enrolled are required to have adequate hematologic, hepatic, and renal function 8. Life expectancy longer than 12 weeks 9. No serious medical history of heart, lung, liver and kidney 10. Be able to understand the study procedures and sign informed consent. 11. Patients with good compliance.
Exclusion criteria
1. Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days before the first day of drug dosing, or, if positive, a pregnancy should be ruled out by ultrasound) 2. Women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study 3. Treatment with radiotherapy at the axial skeleton within 4 weeks before the first treatment or has not recovered from all toxicities of previous radiotherapy 4. Treatment with an investigational product within 4 weeks before the first treatment 5. Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to the registration 6. Other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia. 7. Patients having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions 8. Uncontrolled serious infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | approximately 6 weeks | Progression Free Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | approximately 6 weeks | Objective Response Rate |
| OS | Up to approximately 30 months | Overall Survival |
Countries
China
Outcome results
None listed