NCT06857747

Disitamab Vedotin in Combination with Metronomic Chemotherapy in Advanced HER2-expressing Breast Cancer.

An Exploratory, Multicenter, Multi-cohort Phase II Clinical Trial of Disitamab Vedotin in Combination with Metronomic Chemotherapy in Advanced HER2-expressing Breast Cancer.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: QIAO LI · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to explore the efficacy of Disitamab vedotin in combination with metronomic chemotherapy in advanced breast cancer. By integrating the rapid onset of action of Disitamab vedotin with the characteristics of metronomic chemotherapy, the study seeks to further improve patients' response rates and enhance their quality of life, building upon the extension of patient survival.

Detailed description

Disitamab vedotin is a novel, cleavable antibody-drug conjugate (ADC) targeting HER2, with prior research indicating its efficacy in HER2-positive and low-expressing breast cancer. Patients with advanced breast cancer often have compromised general conditions, and some may have received conventional intensity chemotherapy, making further treatment challenging. Metronomic chemotherapy, characterized by lower drug doses, reduced intensity, continuous administration, and fewer adverse effects, offers the potential to improve quality of life and prolong survival for these patients. This study aims to explore the efficacy of disitamab vedotin in combination with metronomic chemotherapy in advanced breast cancer. By combining the rapid onset of action of disitamab vedotin with the characteristics of metronomic chemotherapy, the study seeks to not only extend patient survival but also enhance response rates and improve quality of life.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine	metronomic capecitabine, 500 mg, tid， po
DRUG	Vinorelbine	metronomic vinorelbine, 40mg/d, TIW1, po
DRUG	Etoposide	metronomic etoposide, 50mg/d, po

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-12-01
• Completion: 2026-04-01
• First posted: 2025-03-04
• Last updated: 2025-03-04