Oral Vinorelbine and Capecitabine in Advanced HER2-negative Breast Cancer

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Treatments: Capecitabine; Vinorelbine

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.