Albumin-bound Paclitaxel Combination With Capecitabine Versus Capecitabine Monotherapy in Paclitaxel/Docetaxel-resistant Advanced Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Albumin-bound paclitaxel plus capecitabine
capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, Albumin-bound paclitaxel, paclitaxel/docetaxel-resistant
Eligibility Criteria
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
Sites / Locations
- Fudan University Shanghai Cancer centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Albumin-bound paclitaxel plus capecitabine
Capecitabine
Arm Description
Albumin-bound paclitaxel combined with capecitabine
Capecitabine
Outcomes
Primary Outcome Measures
PFS
Progression Free Survival
Secondary Outcome Measures
ORR
Objective Response Rate
OS
Overall Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04780347
Brief Title
Albumin-bound Paclitaxel Combination With Capecitabine Versus Capecitabine Monotherapy in Paclitaxel/Docetaxel-resistant Advanced Breast Cancer
Official Title
A Phase II, Single-center, Randomized Study of Albumin-bound Paclitaxel Combination With Capecitabine Versus Capecitabine Monotherapy in Paclitaxel/Docetaxel-resistant Advanced Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
February 25, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Albumin-bound paclitaxel, paclitaxel/docetaxel-resistant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Albumin-bound paclitaxel plus capecitabine
Arm Type
Experimental
Arm Description
Albumin-bound paclitaxel combined with capecitabine
Arm Title
Capecitabine
Arm Type
Active Comparator
Arm Description
Capecitabine
Intervention Type
Drug
Intervention Name(s)
Albumin-bound paclitaxel plus capecitabine
Intervention Description
Albumin-bound paclitaxel plus capecitabine: Albumin-bound paclitaxel 260mg/m2, IV , D1, q3w; capecitabine 1000 mg/m2, PO,bid, D1-14,q3w.
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Description
capecitabine: capecitabine 1000 mg/m2, PO,bid, D1-14,q3w.
Primary Outcome Measure Information:
Title
PFS
Description
Progression Free Survival
Time Frame
approximately 6 weeks
Secondary Outcome Measure Information:
Title
ORR
Description
Objective Response Rate
Time Frame
approximately 6 weeks
Title
OS
Description
Overall Survival
Time Frame
Up to approximately 30 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fudan University Shanghai Cancer center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Zhang, MD,PhD
Phone
+8618121299359
Email
syner2000@163.com
First Name & Middle Initial & Last Name & Degree
Yiqun Du, MD,PhD
Phone
+8618121299359
Email
dyqlh2010@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Albumin-bound Paclitaxel Combination With Capecitabine Versus Capecitabine Monotherapy in Paclitaxel/Docetaxel-resistant Advanced Breast Cancer
We'll reach out to this number within 24 hrs