To hear about similar clinical trials, please enter your email below
Trial Title:
Oral Vinorelbine and Capecitabine in Advanced HER2-negative Breast Cancer
NCT ID:
NCT05747326
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Capecitabine
Vinorelbine
Conditions: Keywords:
Breast Cancer
metronomic treatment
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This study was a prospective, single-arm, open-label phase II clinical trial conducted at
National cancer center in China. The eligible patients were enrolled to receive oral
metronomic vinorelbine 40 mg on day 1, day 3, day 5 every week (Monday, Wednesday, and
Friday) and capecitabine 500mg three times daily (tid) after meals every 3 weeks. Until
disease progression or unacceptable toxicity occurred, or the patient refused medication,
vinorelbine and capecitabine were administered continuously without drug-free periods
over 21-day cycles.
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
Open Label
Intervention:
Intervention type:
Drug
Intervention name:
oral vinorelbine and capecitabine
Description:
The eligible patients were enrolled to receive oral metronomic vinorelbine 40 mg on day
1, day 3, day 5 every week (Monday, Wednesday, and Friday) and capecitabine 500mg three
times daily (tid) after meals every 3 weeks. Until disease progression or unacceptable
toxicity occurred, or the patient refused medication, vinorelbine and capecitabine were
administered continuously without drug-free periods over 21-day cycles.
Arm group label:
Study group
Other name:
metronomic agents (vinorelbine and capecitabine )
Summary:
This study was a prospective, single-arm, open-label phase II clinical trial conducted at
National cancer center in China.
Detailed description:
Metronomic chemotherapy is a relatively low-dose, high-frequency, continuous application
of cytotoxic agents. Phase I/II VICTOR-1 studies have shown that the dual oral beat
combination of vincristine and capecitabine is highly active and well tolerated in
patients with locally advanced or metastatic breast cancer. The long-term efficacy of
oral two-metronomic agents (vinorelbine and capecitabine) in Chinese advanced HER-2
negative breast cancer patients stays unclear. The current study was designed to explore
the efficacy of oral two-metronomic agents (vinorelbine and capecitabine) in advanced
HER-2 negative patient China.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- female;
- aged ≥ 18 years and ≤75 years;
- histologically proved metastatic HER-2 negative breast cancer. HER2-negative status
determined by situ hybridization (FISH) or immunohistochemistry (IHC) (IHC 0, 1+, 2+
and/or FISH HER2 negative);
- at least one measurable or evaluable lesion based on RECIST 1.1 criteria;
- estimated life expectancy ≥ 3 months;
- normal heart, liver, and kidney function;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
- informed consent signed by the participants
Exclusion Criteria:
- received neoadjuvant or adjuvant therapy containing vinorelbine or capecitabine
within one year prior to treatment initiation;
- participated in other new drug clinical trials within 4 weeks before enrollment;
- inflammatory breast cancer;
- symptomatic visceral disease;
- second primary malignancy;
- mental disorder.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Address:
City:
Beijing
Zip:
00
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiao Li, Dr.
Phone:
+8615910573527
Email:
liqiaopumc@qq.com
Contact backup:
Last name:
Yue Chai, Dr.
Phone:
13350804092
Email:
cy972628990@163.com
Start date:
January 1, 2022
Completion date:
June 2023
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05747326
