Back to resultsOral Vinorelbine and Capecitabine in Advanced HER2-negative Breast Cancer
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
oral vinorelbine and capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, metronomic treatment
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.
Sites / Locations
- National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm 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.
Outcomes
Primary Outcome Measures
Progression-free Survival
1-year progression-free survival (PFS1). Evidence of local recurrence, distant metastasis, or death from any cause within 1 year counted as events in the time-to-event Kaplan-Meier analysis of progression-free survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Secondary Outcome Measures
Proportion of Confirmed Response, Defined as a Partial Response (PR) or Better
Confirmed response will be evaluated using all cycles. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR Confirmed response will be evaluated using all cycles. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Full Information
NCT ID
NCT05747326
First Posted
February 17, 2023
Last Updated
February 27, 2023
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05747326
Brief Title
Oral Vinorelbine and Capecitabine in Advanced HER2-negative Breast Cancer
Official Title
A Doublelet Metronomic Chemotherapeutic Regimen With Oral Vinorelbine and Capecitabine in Advanced HER2-negative Breast Cancer Patients: A Monocentric Retrospective Study in China
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Institute and Hospital, 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, metronomic treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
oral vinorelbine and capecitabine
Other Intervention Name(s)
metronomic agents (vinorelbine and capecitabine )
Intervention 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.
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
1-year progression-free survival (PFS1). Evidence of local recurrence, distant metastasis, or death from any cause within 1 year counted as events in the time-to-event Kaplan-Meier analysis of progression-free survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame
At 1 year
Secondary Outcome Measure Information:
Title
Proportion of Confirmed Response, Defined as a Partial Response (PR) or Better
Description
Confirmed response will be evaluated using all cycles. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR Confirmed response will be evaluated using all cycles. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame
Up to 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiao Li, Dr.
Phone
+8615910573527
Ext
87788819
Email
liqiaopumc@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Chai, Dr.
Phone
13350804092
Email
cy972628990@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binghe Xu
Organizational Affiliation
National Cancer Center/National Clinical Research Center for Cancer
Official's Role
Study Director
Facility Information:
Facility Name
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
00
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiao Li, Dr.
Phone
+8615910573527
Email
liqiaopumc@qq.com
First Name & Middle Initial & Last Name & Degree
Yue Chai, Dr.
Phone
13350804092
Email
cy972628990@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual anonymized participant data will not be shared.
Learn more about this trial
Oral Vinorelbine and Capecitabine in Advanced HER2-negative Breast Cancer
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