Albumin-bound Paclitaxel Combination With Capecitabine Versus Capecitabine Monotherapy in Paclitaxel/Docetaxel-resistant Advanced Breast Cancer

Study Overview
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Brief Summary
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Albumin-bound Paclitaxel Combination With Capecitabine Versus Capecitabine Monotherapy in Paclitaxel/Docetaxel-resistant Advanced Breast Cancer

Detailed Description
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A Phase II, single-center, randomized study of albumin-bound paclitaxel combination with capecitabine versus capecitabine monotherapy in paclitaxel/docetaxel-resistant advanced breast cancer.

Official Title
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A Phase II, Single-center, Randomized Study of Albumin-bound Paclitaxel Combination With Capecitabine Versus Capecitabine Monotherapy in Paclitaxel/Docetaxel-resistant Advanced Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Albumin-bound paclitaxel plus capecitabine
* Drug: capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females with age between 18 and 70 years old Histological proven unresectable recurrent or advanced breast cancer 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. Patients who developed disease progression within 12 months of previous paclitaxel-containing chemotherapy regimens. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1) Performance status no more than 1 All patients enrolled are required to have adequate hematologic, hepatic, and renal function Life expectancy longer than 12 weeks No serious medical history of heart, lung, liver and kidney Be able to understand the study procedures and sign informed consent. Patients with good compliance. Exclusion Criteria: 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) Women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study Treatment with radiotherapy at the axial skeleton within 4 weeks before the first treatment or has not recovered from all toxicities of previous radiotherapy Treatment with an investigational product within 4 weeks before the first treatment 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 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. 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 Uncontrolled serious infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Albumin-bound paclitaxel plus capecitabine<br>Albumin-bound paclitaxel combined with capecitabine | Drug: Albumin-bound paclitaxel plus capecitabine<br>* Albumin-bound paclitaxel plus capecitabine: Albumin-bound paclitaxel 260mg/m2, IV , D1, q3w； capecitabine 1000 mg/m2, PO，bid, D1-14,q3w.<br>|
| Active Comparator: Capecitabine<br>Capecitabine | Drug: capecitabine<br>* capecitabine: capecitabine 1000 mg/m2, PO，bid, D1-14,q3w.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression Free Survival | approximately 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective Response Rate | approximately 6 weeks | 
| OS | Overall Survival | Up to approximately 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Albumin-bound paclitaxel, paclitaxel/docetaxel-resistant, Breast cancer