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

NCT02596373 | Unknown Phase 2

• 1 other identifier: CSPC-HE1506/PRO/Ⅰ
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Recurrent or Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• ORR(Objective reponse rate)

  4-8 Months

Secondary Outcomes (1)

• PFS(Progression free survival)

  2.5 Years

Study Arms (2)

Mitoxantrone Hydrochloride Liposome Injection

EXPERIMENTAL

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

Drug: Mitoxantrone Hydrochloride Liposome Injection

Mitoxantrone Hydrochloride Injection

ACTIVE COMPARATOR

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

Drug: Mitoxantrone Hydrochloride Liposome Injection

Interventions

Mitoxantrone Hydrochloride Liposome Injection DRUG

Mitoxantrone Hydrochloride Injection; Mitoxantrone Hydrochloride Liposome Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 34633576 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xichun Hu, Ph.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xichun Hu, Ph.D

CONTACT

+8613816110335; xchu2009@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 4, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

CN (1)