NCT03562390

Irinotecan for Advanced and Metastatic Breast Cancer

Irinotecan for Advanced and Metastatic Breast Cancer Previously Treated Using Anthracyclines- and Taxanes-containing Regimens: Protocol for a Phase II, Open-label, Single-arm Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Liaoning Cancer Hospital & Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This trial aims to evaluate the safety and efficacy of third-line or later irinotecan treatment for locally recurrent or metastatic breast cancer among Chinese patients who have received at least two regimens containing anthracyclines and taxanes.

Detailed description

Anthracyclines and taxanes are the most effective first-line and second-line treatments for breast cancer, although increased usage in early treatment lines can make it difficult to select a third-line or later treatment. This issue is further complicated by the fact that patients with metastatic breast cancer can become resistant to anthracyclines and taxanes. Thus, there are no consistent international guidelines regarding treatment in this setting. In China, the treatment procedures for metastatic breast cancer follow the National Comprehensive Cancer Network guidelines, which recommend single-drug treatments for recurrent or metastatic disease, which typically involve anthracyclines, taxanes, vinorelbine, gemcitabine, capecitabine, and eribulin. However, there is no standard international recommendation for patients with metastatic breast cancer who have developed resistance to anthracyclines and taxanes, and there are limited options for third-line or later treatment in this setting. This trial aims to evaluate the safety and efficacy of third-line or later irinotecan treatment for locally recurrent or metastatic breast cancer among Chinese patients who have received at least two regimens containing anthracyclines and taxanes.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan	The patients will receive treatment using intravenous irinotecan hydrochloride until the patient develops disease progression or fulfills a withdrawal criterion.

Timeline

• Start date: 2017-04-01
• Primary completion: 2020-01-01
• Completion: 2021-12-01
• First posted: 2018-06-19
• Last updated: 2018-06-19

Locations

1 site across 1 country: China