NCT06156761

Mitoxantrone Hydrochloride Liposome Combined With Capecitabine in Patients With HER-2 Negative Advanced Breast Cancer

Clinical Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Capecitabine in Patients With HER-2 Negative Advanced Breast Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the dose-limiting toxicity of mitoxantrone hydrochloride liposome combined with capecitabine in patients with HER-2 negative advanced breast cancer who have received at least first-line treatment, explore the maximum tolerated dose (MTD) of mitoxantrone hydrochloride liposome, and determine the recommended phase II dose (RP2D).

Detailed description

This is a single-center, open-label, phase I dose-increasing study following the "3+3" principle, which planned to enroll a maximum of 48 clinically confirmed patients with advanced HER-2 negative breast cancer who have received at least first-line treatment, to explore the MTD of mitoxantrone hydrochloride liposome.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Mitoxantrone hydrochloride liposome	Drug: Mitoxantrone hydrochloride liposome (16 mg/m\^2, 18 mg/m\^2, 20 mg/m\^2 and 22 mg/m\^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
DRUG	Capecitabine	Capecitabine (1000 mg/m\^2) will be administered orally in a 3-week treatment cycle, twice a day from day 1 to day 14 of each cycle.
DRUG	Mitoxantrone hydrochloride liposome	Mitoxantrone hydrochloride liposome (16 mg/m\^2, 18 mg/m\^2, 20 mg/m\^2 and 22 mg/m\^2) will be administered by intravenous infusion on day 1 in a 4-week treatment cycle.
DRUG	Capecitabine	Capecitabine (825 mg/m\^2) will be administered orally in a 4-week treatment cycle, twice a day from day 1 to day 21 of each cycle.

Timeline

• Start date: 2023-11-28
• Primary completion: 2024-04-01
• Completion: 2025-04-01
• First posted: 2023-12-05
• Last updated: 2023-12-05

Locations

1 site across 1 country: China