Nab-Paclitaxel in Patients With ER+/HER2- Recurrent Metastatic Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
nab-paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Female, 18 to 70 years old;
- histologically confirmed recurrent or metastatic breast cancer, ER-positive (> 10%), HER-2 negative (Definition: immunohistochemical [IHC] 0, 1+, or in situ hybridization [ISH] negative It is defined as the ratio of HER2 gene copy number to the number of CEP17 signals is less than 2.0, or for single probe detection, the HER2 gene copy number is less than 6);
- After transfer, ≤2 lines and ≥1 line endocrine therapy, and progress;
- at least one measurable lesion according to RECIST 1.1 ;
- ECOG score≤2;
- Expected survival≥3 months;
- Bone marrow function: white blood cells≥3×109/L, neutrophils≥1.5×109/L, platelets ≥100×109 / L, hemoglobin≥90g / L;
- Liver and kidney function: total bilirubin (TBIL) ≤1.5 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) are ≤2.5 times the upper limit of normal value; if due to liver metastasis, the above indicators ≤5 times the upper limit of normal value; serum creatinine (Cr) ≤1.5 times the upper limit of normal value;
- taxane adjuvant chemotherapy for more than 1 year;
- Women of childbearing age have a negative pregnancy test and must agree to take effective contraceptive measures during the study and within 3 months after the last dose
- Sign written informed consent before the test.
Exclusion Criteria:
- Received chemotherapy after transfer;
- Patients with congestive heart failure with a grade II or above identified by the New York Heart Association (NYHA) score;
- Uncontrolled brain metastases;
- Severe systemic infections;
- Peripheral neuropathy of degree II or above within 4 weeks before enrollment, or patients known to be allergic or intolerant to this drug;
- Important organ diseases:liver and kidney dysfunction, history of myocardial infarction, unstable heart disease, chronic active hepatitis, etc .;
- History of other malignant tumors within 5 years (except cured cervical cancer or skin basal cell carcinoma);
- Received other anti-tumor treatments or other experimental drugs within 1 month before starting treatment;
- Patients participating in other clinical trials at the same time;
- Any medical condition in which the investigator considers the patient unsuitable for study
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Assigned Interventions
Arm Description
Nab-paclitaxel
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR)
Defined as proportion of complete response and partial response according to RECIST 1.1 criteria.
Secondary Outcome Measures
Clinical benefit rate
Defined as proportion of complete response 、partial response and stable disease according to RECIST 1.1 criteria.
Progression-Free Survival (PFS)
Calculated from the time the study drug was first administered to the first confirmation of disease progression or death (whichever occurs first)
Full Information
NCT ID
NCT04194684
First Posted
December 10, 2019
Last Updated
December 10, 2019
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04194684
Brief Title
Nab-Paclitaxel in Patients With ER+/HER2- Recurrent Metastatic Breast Cancer
Official Title
Nab-Paclitaxel in Patients With ER+/HER2- Recurrent Metastatic Breast Cancer:a Multi-center Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 28, 2019 (Anticipated)
Primary Completion Date
December 28, 2022 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
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
This study is a single-arm, open, multi-center clinical study of nab-paclitaxel as the therapy ER+/HER2- recurrent metastatic breast cancer。
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Assigned Interventions
Arm Type
Experimental
Arm Description
Nab-paclitaxel
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel
Intervention Description
nab-paclitaxel 125mg / m2, intravenous drip 30min, d1, 8, 21 days as a cycle, until the disease progresses or intolerable toxicity. According to the calculation results, the administered dose can be within ± 10% of the calculated dose.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Defined as proportion of complete response and partial response according to RECIST 1.1 criteria.
Time Frame
Estimated up to 1 year
Secondary Outcome Measure Information:
Title
Clinical benefit rate
Description
Defined as proportion of complete response 、partial response and stable disease according to RECIST 1.1 criteria.
Time Frame
CR+PR+SD≥8 weeks
Title
Progression-Free Survival (PFS)
Description
Calculated from the time the study drug was first administered to the first confirmation of disease progression or death (whichever occurs first)
Time Frame
Estimated up to 2 year
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:
Female, 18 to 70 years old;
histologically confirmed recurrent or metastatic breast cancer, ER-positive (> 10%), HER-2 negative (Definition: immunohistochemical [IHC] 0, 1+, or in situ hybridization [ISH] negative It is defined as the ratio of HER2 gene copy number to the number of CEP17 signals is less than 2.0, or for single probe detection, the HER2 gene copy number is less than 6);
After transfer, ≤2 lines and ≥1 line endocrine therapy, and progress;
at least one measurable lesion according to RECIST 1.1 ;
ECOG score≤2;
Expected survival≥3 months;
Bone marrow function: white blood cells≥3×109/L, neutrophils≥1.5×109/L, platelets ≥100×109 / L, hemoglobin≥90g / L;
Liver and kidney function: total bilirubin (TBIL) ≤1.5 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) are ≤2.5 times the upper limit of normal value; if due to liver metastasis, the above indicators ≤5 times the upper limit of normal value; serum creatinine (Cr) ≤1.5 times the upper limit of normal value;
taxane adjuvant chemotherapy for more than 1 year;
Women of childbearing age have a negative pregnancy test and must agree to take effective contraceptive measures during the study and within 3 months after the last dose
Sign written informed consent before the test.
Exclusion Criteria:
Received chemotherapy after transfer;
Patients with congestive heart failure with a grade II or above identified by the New York Heart Association (NYHA) score;
Uncontrolled brain metastases;
Severe systemic infections;
Peripheral neuropathy of degree II or above within 4 weeks before enrollment, or patients known to be allergic or intolerant to this drug;
Important organ diseases:liver and kidney dysfunction, history of myocardial infarction, unstable heart disease, chronic active hepatitis, etc .;
History of other malignant tumors within 5 years (except cured cervical cancer or skin basal cell carcinoma);
Received other anti-tumor treatments or other experimental drugs within 1 month before starting treatment;
Patients participating in other clinical trials at the same time;
Any medical condition in which the investigator considers the patient unsuitable for study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Yuan
Phone
+8613501270834
Email
yuanpeng01@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peng Yuan
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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Nab-Paclitaxel in Patients With ER+/HER2- Recurrent Metastatic Breast Cancer
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