A Multicenter, Open-label, Single-arm, Phase II Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced HER2 Negative Breast Cancer

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.29 sites in 1 country28 target enrollmentJune 11, 2021

ConditionsBreast Cancer

InterventionsMitoxantrone Hydrochloride Liposome Injection

DrugsMitoxantrone Hydrochloride Liposome Injection

Overview

Phase: Phase 2
Intervention: Mitoxantrone Hydrochloride Liposome Injection
Conditions: Breast Cancer
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Enrollment: 28
Locations: 29
Primary Endpoint: Objective response rate (ORR)
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, open-label, single-arm, phase II study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in patients with advanced HER2 negative breast cancer.

Detailed Description

This is a multicenter, open-label, single-arm, phase II study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in patients with advanced HER2 negative breast cancer. Eligible patients will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2 by an intravenous infusion (IV), every 21 days (q3w, 1 cycle) until disease progression, intolerable toxicity, death, or investigator or patient decision.

Registry

clinicaltrials.gov

Start Date

June 11, 2021

End Date

January 17, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntarily participate in this study and sign informed consent form;
•Male or female patients aged 18 to 75 years (inclusive);
•Histologically confirmed diagnosis of HER-2 negative breast cancer (Including immunohistochemistry HER2 0 or 1+, immunohistochemistry HER2 2+ must be confirmed as negative by in situ hybridization);
•Patients with unresectable locally advanced or recurrent breast cancer with disease progression after first-line or higher chemotherapy；
•Hormone receptor (HR) negative breast cancer or HR-positive breast cancer that is not suitable for endocrine treatment or is resistant to endocrine treatment.
•Prior treatment with both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel) at least (acceptable for patients not previously treated with anthracyclines due to high risk factors for cardiotoxicity), and four prior chemotherapy regimens at most；
•At least one measurable lesion according to RECIST v1.1;
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
•Patients must meet the following criteria prior to treatment (not receiving blood transfusion or growth factors therapy within 14 days before the first administration):
•Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;

Exclusion Criteria

•Patients who have severe allergic reactions to mitoxantrone hydrochloride or liposome preparation ingredients;
•History of other malignancy within 3 years, except for radical cure of carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin;
•Brain metastases and meningeal metastasis;
•Patients with active hepatitis B (HBsAg positive with hepatitis B virus DNA ≥ 2000 IU/mL), active hepatitis C (hepatitis C virus antibody positive with hepatitis C virus RNA above the lower limit of detection of the study center), or human immunodeficiency virus (HIV) antibody positive;
•Life expectancy \< 3 months;
•Previous treatment with the anthracyclines, with the total cumulative dose (doxorubicin equivalent) \>350 mg/m2;
•Adverse events from the previous treatment have not resolved to ≤ Grade 1 based on CTCAE (except for the toxicity without safety risk judged by the investigator, such as alopecia, hyperpigmentation);
•Impaired cardiac function or serious cardiac disease:
•Long corrected QT interval syndrome or corrected QT interval \> 480 ms;
•Complete left bundle branch block, II-III degree atrioventricular block;

Arms & Interventions

Mitoxantrone Hydrochloride Liposome Injection

Patients with advanced HER2 negative breast cancer will receive 20 mg/m2 Mitoxantrone Hydrochloride Liposome injection every 21 days (a cycle) for about 6 cycles.

Intervention: Mitoxantrone Hydrochloride Liposome Injection

Outcomes

Primary Outcomes

Objective response rate (ORR)

Time Frame: From the enrollment to the final documentation of response of the last subject(assessed up to 36 months)

To investigate the preliminary antitumor efficacy

Secondary Outcomes

Overall survival (OS)(From the enrollment to death,lost to follow-up,withdrawal,or study end,whichever occurred first,assessed up to 36 months)
Disease control rate (DCR)(From the enrollment to the final documentation of response of the last subject(assessed up to 36 months))
Progression-free survival (PFS)(From the enrollment to death,lost to follow-up,withdrawal,or study end,whichever occurred first,assessed up to 36 months)
Duration of response (DoR)(From the enrollment to death,lost to follow-up,withdrawal,or study end,whichever occurred first,assessed up to 36 months)
Treatment emergent adverse events (TEAEs)(from the administration of the first dose to 28 days after the last dose)