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

NCT06156761 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-12-05

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Binghe Xu, PHD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-28
Primary Completion
2024-04-30
Completion
2025-04-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06156761 on ClinicalTrials.gov