A Study of Mitoxantrone Hydrochloride Liposome Injection in Advanced Recurrent or Metastatic Breast Cancer

NCT ID: NCT02596373

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2018-09-30

Brief Summary

The hypothesis of this clinical research study is to discover if the study drug Mitoxantrone Hydrochloride Liposome Injection can shrink or slow the growth of advanced recurrent or metastatic breast cancer

Detailed Description

Mitoxantrone Hydrochloride Liposome Injection is a kind of anthraquinone compounds, and its antineoplastic effect has been viewed in preclinical tests. The investigator's phase Ⅰstudy has shown that the drug's toxicity is manageable and the tolerable does is 20 mg/m2. The hypothesis of this clinical research study is to discover if the study drug Mitoxantrone Hydrochloride Liposome Injection can shrink or slow the growth of advanced recurrent or metastatic breast cancer. The safety of Mitoxantrone Hydrochloride Liposome Injection will also be studied. Patients physical state, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if Mitoxantrone Hydrochloride Liposome Injection is safe and effective in advanced recurrent or metastatic breast cancer patients.

Conditions

Advanced Recurrent or Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mitoxantrone Hydrochloride Liposome Injection

Mitoxantrone Hydrochloride Liposome Injection 20 mg/m2 will be infused intravenously once over 1 hours in 250 ml 5％ glucose injection on the first day during a treatment phase of 4 weeks

Group Type: EXPERIMENTAL

Mitoxantrone Hydrochloride Liposome Injection

Intervention Type: DRUG

Mitoxantrone Hydrochloride Injection

Mitoxantrone Hydrochloride Injection 14 mg/m2 will be infused intravenously once over 30 minutes in 150 ml 5％ glucose injection on the first day during a treatment phase of 4 weeks

Group Type: ACTIVE_COMPARATOR

Mitoxantrone Hydrochloride Liposome Injection

Intervention Type: DRUG

Interventions

Mitoxantrone Hydrochloride Liposome Injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Written informed consent prior to study specific screening procedures;
• ≥ 18 and ≤ 75 years of age,female;
• Advanced recurrent or Metastatic breast cancer, comfirmed by histological analysis and/or cytology analysis. Have failed for at least two chemotherapy regimen aimed to the advanced recurrent or metastatic focus;
• Adapted to receive chemotherapy;
• Women diagnosed with human epidermal growth factor receptor negative(HER2-); Women diagnosed with HER2+, and unable to be treated by Anti-HER2+ targeted therapy. HER2- is defined as 0 or 1+ staining on immunohistochemistry or FISH negative for gene amplification. HER2+ is defined as +++ staining on immunohistochemistry or FISH positive for gene amplification;
• Not suitable for endocrine theapy or tolerance to endocrine therapy;
• Have at least one measurable site of disease according to RECIST1.1 criteria;
• If chemotherapy regimens containing anthracycline-based drugs, duration from palindromia to this chemotherapy regimens is not less than 12 mounths;
• ECOG performance status of 0-2, life expectancy of more than 3 mounths;
• Cardiac function is almost normal(NYHA classification is Grade 1, LVEF≥ 50％);
• Sexually active women of childbearing potential must use a medically acceptable form of contraception;
• Adequate hepatic, renal and hematologic functions: leukocyte≥3.0×10^9/L,neutrophils≥1.5×10^9/L,platelets≥75×10^9/L, hemoglobin≥90g/L, serum bilirubin≤1.5×ULN, ALT≤2.5×ULN(5×for liver metastasis),AST≤2.5×ULN(5×for liver metastasis), creatinine clearance rate≤1.5×ULN;

Exclusion Criteria

• Suffering from serious internal disease, including serious heart attack, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer;
• Uncontrolled brain metastases;
• Pregnant or lactating women;
• Mitoxantrone has been used before;
• Anthracycline-based drugs was used after relapse and metastasis;
• The cumulative doses of doxorubicin and epirubicin before inclusion have surpassed 360 mg/m2 and 600 mg/m2, respectively;
• Less than 4 weeks from the last chemotherapy, less than 4 weeks from the last radiotherapy, less than 2 weeks from the last endocrinotherapy; Other antineoplastic drugs need to be used in this study;
• History of anthracycline-based drug allergy;
• History of liposome drug allergy;
• Uncontrolled psychosis or uncontrolled infections disease;
• Unsuited to participate in thsi study judged by investigators;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xichun Hu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Cancer Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xichun Hu, Ph.D

Role: CONTACT

xchu2009@hotmail.com

+8613816110335

Facility Contacts

Xichun Hu, Ph.D

Role: primary

xchu2009@hotmail.com

+8613816110335

References

Wang L, Cao J, Li C, Wang X, Zhao Y, Li T, Du Y, Tao Z, Peng W, Wang B, Zhang J, Zhang S, Wang Z, Hu X. Efficacy and safety of mitoxantrone hydrochloride liposome injection in Chinese patients with advanced breast cancer: a randomized, open-label, active-controlled, single-center, phase II clinical trial. Invest New Drugs. 2022 Apr;40(2):330-339. doi: 10.1007/s10637-021-01182-7. Epub 2021 Oct 11.

Reference Type: DERIVED

PMID: 34633576 (View on PubMed)

Other Identifiers

CSPC-HE1506/PRO/Ⅰ

Identifier Type: -

Identifier Source: org_study_id