Breast Cancer Clinical Trial
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
NCT number | NCT05747326 |
Other study ID # | m-VCAP1 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | January 1, 2022 |
Est. completion date | June 2023 |
This study was a prospective, single-arm, open-label phase II clinical trial conducted at National cancer center in China.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | At 1 year | |
Secondary | 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 | Up to 1 year |
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