Oral Vinorelbine and Capecitabine in Advanced HER2-negative Breast Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2

Conditions: Breast Cancer

Treatments: Drug: oral vinorelbine and capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT05747326

m-VCAP1

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Study group

Experimental group

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.

Treatment:

Drug: oral vinorelbine and capecitabine