To hear about similar clinical trials, please enter your email below
Trial Title:
Eribulin Mesylate Combined With Lobaplatin in the Treatment of Recurrent or Metastatic Triple-negative Breast Cancer
NCT ID:
NCT05546255
Condition:
Triple Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Eribulin Mesylate
Description:
The recommended dose of Eribulin is 1.4 mg/m2 administered intravenously over 2 to 5
minutes on Days 1
Arm group label:
Eribulin Combined With Lobaplatin
Intervention type:
Drug
Intervention name:
Lobaplatin
Description:
The recommended dose of lobaplatin is 25mg/m2 administered intravenously over on Days 1
Arm group label:
Eribulin Combined With Lobaplatin
Summary:
A prospective phase II study conducted at the Cancer Hospital Chinese Academy of Medical
Sciences to compare the effectiveness of eribulin combined with lobaplatin in the
treatment of recurrent or metastatic triple-negative breast cancer
Detailed description:
This study is designed to be a prospective phase II study conducted at the Cancer
Hospital Chinese Academy of Medical Sciences. The target populations of this study are
patients with recurrent or metastatic triple-negative breast cancer who received the
therapy of eribulin combined with lobaplatin from July 1, 2020 to December 31, 2022. It
is expected to enroll 40 subjects in this study. The subjects' data such as demographics
and other baseline characteristics, medications, prognosis, will be collected, and
statistical analysis of data will be conducted to compare the effectiveness outcome
measures.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Female aged between 18 and 75
2. Recurrence or metastasis OF TNBC confirmed by histological or cytological methods,
TNBC definitions of ER, PR and HER-2 are negative, if there is metastasis pathology,
the histological pathology of metastasis shall prevail.ER and PR negative were
defined as ER < 10% positive and PR < 10% positive.
3. Disease progression after at least one prior systemic treatment and anthracycline
and/or taxane use;Note: For neoadjuvant/adjuvant therapy, recurrence or disease
progression during treatment or within 6 months of discontinuation of treatment
should be counted as first-line systemic treatment failure;
4. There should be at least one measurable lesion according to the efficacy evaluation
criteria for solid tumors (RECIST version 1.1)
Exclusion Criteria:
1. The number of previous treatment lines (including postoperative adjuvant therapy) <2
lines
2. symptomatic central system metastases. Patients with stable asymptomatic BMS who
have received brain radiation and who have at least one other evaluable target in
addition to the BMS can be enrolled (evaluable target should be at least 4 weeks
away from the last radiotherapy).
3. New bisphosphonate or dinoselmer treatment for bone metastases was initiated within
28 days prior to study initiation.(Subjects are permitted if they have already been
treated with bisphosphonate or dinoselmer for at least 4 weeks of optimal stable
administration prior to study initiation.)Subjects already enrolled in this study
may begin treatment with bisphosphonate or dinoselmer for bone metastases after the
first post-treatment evaluation
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Peng Yuan, doctor
Phone:
8613501270834
Email:
yuanpeng01@hotmail.com
Investigator:
Last name:
Peng Yuan, MD
Email:
Principal Investigator
Start date:
June 1, 2020
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Chinese Academy of Medical Sciences
Agency class:
Other
Source:
ChineseAMS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05546255
