A Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced HER2 Negative Breast Cancer

NCT04927481 | Terminated Phase 2

• 1 other identifier: HE071-CSP-021
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 29

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  To investigate the preliminary antitumor efficacy

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

Secondary Outcomes (5)

• Disease control rate (DCR)

  From the enrollment to the final documentation of response of the last subject(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

• 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

• Overall survival (OS)

  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

Study Arms (1)

Mitoxantrone Hydrochloride Liposome Injection

EXPERIMENTAL

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.

Drug: Mitoxantrone Hydrochloride Liposome Injection

Interventions

Mitoxantrone Hydrochloride Liposome Injection DRUG

Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).

Mitoxantrone Hydrochloride Liposome Injection

Eligibility Criteria

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

You may qualify if:

• 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;
• Hemoglobin ≥ 90g / L;
• Platelet count ≥ 90 × 109/L;
• Creatinine ≤1.5 × upper limit of normal (ULN);
• Total bilirubin ≤ 1.5×ULN;
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 ×ULN (≤ 5 ×ULN for liver metastasis);

You may not qualify if:

• 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;
• Severe, uncontrolled arrhythmias requiring pharmacological treatment;
• History of chronic congestive heart failure, New York Heart Association ≥ grade 3;
• Cardiac ejection fraction \< 50% within 6 months prior to screening;
• Heart valve disease with CTCAE ≥ grade 3;
• ECG evidence of myocardial infarction, unstable angina, severe ventricular arrhythmias, history of severe pericardial disease, and acute ischemic or active conduction system abnormalities within 6 months prior to screening;

Sponsors & Collaborators

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

Study Sites (29)

Anhui Provincial Hospical

Hefei, Anhui, 230000, China

Location

Cancer Center Sun Yat-sen University

Guozhou, Guodong, 510060, China

Location

Affiliated Hospital of Hebei University

Baoding, Hebei, 071030, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Tangshan People's Hospital

Tangshan, Hebei, 063000, China

Location

Xingtai People's Hospital

Xingtai, Hebei, 054000, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150008, China

Location

Daqing People's Hospital

Daqing, Helongjiang, 163316, China

Location

Cancer Hospital of Jiamusi City

Jiamusi, Helongjiang, 154007, China

Location

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China

Location

Cancer Hospital of Henan Province

Zhengzhou, Henan, 450008, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Henan Provincial People's Hospital

Zhenzhou, Henan, 450008, China

Location

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Changsha Kexin Cancer Hospital

Changsha, Hunan, 413002, China

Location

Yiyang Central Hospital

Yiyang, Hunan, 413002, China

Location

The third Hospital of Nanchang

Nanchang, Jiangxi, 330000, China

Location

The second hospital of Jinlin University

Changchun, Jinlin, 130041, China

Location

The second hospital of Dalian Medical University

Dalian, Liaoning, 116023, China

Location

The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, 121000, China

Location

The First hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, 0300001, China

Location

Yuncheng Central Hospital

Yuncheng, Shanxi, 044000, China

Location

Sichuan Cancer Hospital & Institute

Chengdu, Sichuan, 610041, China

Location

The second people's hospital of neijiang

Neijiang, Sichuan, 641100, China

Location

Affiliated tumor Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830011, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830011, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• qingyuan zhang, PhD

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 16, 2021
• Study Start: June 11, 2021
• Primary Completion: January 17, 2023
• Study Completion: January 17, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

CN (29)