Back to resultsNab-paclitaxel Dose Schedual for HER-2 Negative Advanced Breast Cancer
Primary Purpose
Breast Cancer
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
nab-paclitaxel regimen1
nab-paclitaxel regimen2
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring nab-paclitaxel, advanced breast cancer, HER2 negative, dose
Eligibility Criteria
Inclusion criteria
- Female, aged≥ 18 years old;
- Histopathologically confirmed HER-2 negative (definition: immunohistochemical IHC 0, or 1+, or in situ hybridization ISH, defined as the ratio of HER2 gene copy number to CEP17 signal number less than 2.0, or for single probe detection, HER2 gene copy number less than 6) in patients with recurrent or metastatic breast cancer;
- Up to two previous lines of chemotherapy were permitted for recurrent and metastatic diseases. And for endocrine therapy, the number of treatment lines can be omitted;
- With measurable lesions;
- The physical condition score of the Eastern American Cancer Collaboration Group (ECOG) was less than 1;
- Expected survival period>3 months;
Exclusion Criteria
- New York Heart Association NYHA scores identify patients with congestive heart failure at grade II or above;Uncontrolled brain metastasis;
- Patients with severe systemic infection;Patients with peripheral nerve injury of degree II or above, or known drug allergy or intolerance within 4 weeks before admission;
- Important organ disorders or diseases: liver and kidney dysfunction, history of myocardial infarction, unstable heart disease, chronic active hepatitis,etc;There is a history of other malignant tumors within 5 years (except cured cervical cancer or skin basal cell carcinoma);
- Patients who had received other antineoplastic treatments or other experimental drugs within one month before treatment;
- Patients who also participated in other clinical trials;
- Researchers believe that patients are not suitable for any medical condition to enter the study.
Sites / Locations
- BeijingCancerH
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
2/3dose strategy
3/4dose strategy
Arm Description
HER2 negative advanced breast cancer patient
HER2 negative advanced breast cancer patient
Outcomes
Primary Outcome Measures
PFS of two regimen
progession free survival and objective remission rate was put in to assessment after 2-4 cycle of treatment of either two regimen
Secondary Outcome Measures
Side effect of two regimen
toxicity and tolerability would be evaluated after every cycle of treatment and will report a SAE within 24h
Full Information
NCT ID
NCT04192331
First Posted
April 14, 2019
Last Updated
October 11, 2022
Sponsor
Peking University Cancer Hospital & Institute
1. Study Identification
Unique Protocol Identification Number
NCT04192331
Brief Title
Nab-paclitaxel Dose Schedual for HER-2 Negative Advanced Breast Cancer
Official Title
A Single-arm Opened Randomized Phase II Study of Nab-paclitaxel Dose Schedual in Advanced Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
January 26, 2023 (Anticipated)
Study Completion Date
January 26, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
What is the best dosage of Nab-Paclitaxel for chinese? This study would divide patients into two dosage groups: 1) 125mg/m2, 30 minutes intravenous injection, d1, 8, 21 days for a cycle(clinical use); 2) 125mg/m2 d1, 8, 15, 30 minutes intravenous injection, 28 days for a cycle(guideline recommand). Treatment to disease progression. The efficacy (CR, PR, SD, PD) is evaluated every 2-4 cycles.If the patient withdraws from the trial because he cannot tolerate the toxicity caused by one of the drugs, such as neurotoxicity or bone marrow toxicity, it is recommended to switch to other drugs and follow up to PFS and OS.Each group was planned to include 30 patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
nab-paclitaxel, advanced breast cancer, HER2 negative, dose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2/3dose strategy
Arm Type
Experimental
Arm Description
HER2 negative advanced breast cancer patient
Arm Title
3/4dose strategy
Arm Type
Active Comparator
Arm Description
HER2 negative advanced breast cancer patient
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel regimen1
Other Intervention Name(s)
regimen1
Intervention Description
nab-paclitaxel regimen1 means use abraxine with 125mg/m2 at day 1 and day 8 per 21d.
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel regimen2
Other Intervention Name(s)
regimen2
Intervention Description
nab-paclitaxel regimen2 means use abraxine with 125mg/m2 at day 1 and day 8 and day 15 per 28d.
Primary Outcome Measure Information:
Title
PFS of two regimen
Description
progession free survival and objective remission rate was put in to assessment after 2-4 cycle of treatment of either two regimen
Time Frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary Outcome Measure Information:
Title
Side effect of two regimen
Description
toxicity and tolerability would be evaluated after every cycle of treatment and will report a SAE within 24h
Time Frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Female, aged≥ 18 years old;
Histopathologically confirmed HER-2 negative (definition: immunohistochemical IHC 0, or 1+, or in situ hybridization ISH, defined as the ratio of HER2 gene copy number to CEP17 signal number less than 2.0, or for single probe detection, HER2 gene copy number less than 6) in patients with recurrent or metastatic breast cancer;
Up to two previous lines of chemotherapy were permitted for recurrent and metastatic diseases. And for endocrine therapy, the number of treatment lines can be omitted;
With measurable lesions;
The physical condition score of the Eastern American Cancer Collaboration Group (ECOG) was less than 1;
Expected survival period>3 months;
Exclusion Criteria
New York Heart Association NYHA scores identify patients with congestive heart failure at grade II or above;Uncontrolled brain metastasis;
Patients with severe systemic infection;Patients with peripheral nerve injury of degree II or above, or known drug allergy or intolerance within 4 weeks before admission;
Important organ disorders or diseases: liver and kidney dysfunction, history of myocardial infarction, unstable heart disease, chronic active hepatitis,etc;There is a history of other malignant tumors within 5 years (except cured cervical cancer or skin basal cell carcinoma);
Patients who had received other antineoplastic treatments or other experimental drugs within one month before treatment;
Patients who also participated in other clinical trials;
Researchers believe that patients are not suitable for any medical condition to enter the study.
Facility Information:
Facility Name
BeijingCancerH
City
Haidian
State/Province
Beijing
ZIP/Postal Code
10010
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Nab-paclitaxel Dose Schedual for HER-2 Negative Advanced Breast Cancer
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