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Oral Vinorelbine and Capecitabine in Advanced HER2-negative Breast Cancer

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05747326
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
17
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was a prospective, single-arm, open-label phase II clinical trial conducted at National cancer center in China.

Condition or Disease Intervention/Treatment Phase
  • Drug: oral vinorelbine and capecitabine
 Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
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.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
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study group

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.

Drug: oral vinorelbine and capecitabine
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.
Other Names:
  • metronomic agents (vinorelbine and capecitabine )

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival [At 1 year]

      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

    1. Proportion of Confirmed Response, Defined as a Partial Response (PR) or Better [Up to 1 year]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Beijing Beijing China 00

    Sponsors and Collaborators

    • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Investigators

    • Study Director: Binghe Xu, National Cancer Center/National Clinical Research Center for Cancer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT05747326
    Other Study ID Numbers:
    • m-VCAP1
    First Posted:
    Feb 28, 2023
    Last Update Posted:
    Feb 28, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    Breast Cancer
    metronomic treatment
    Additional relevant MeSH terms:
    Breast Neoplasms
    Capecitabine
    Vinorelbine

    Study Results

    No Results Posted as of Feb 28, 2023