Oral Vinorelbine and Capecitabine in Advanced HER2-negative Breast Cancer

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05747326
• Other study ID #: m-VCAP1
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2022
• Est. completion date: June 2023

Study information

• Verified date: February 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Qiao Li, Dr.
• Phone: +8615910573527
• Email: liqiaopumc[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

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