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

Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04927481
Collaborator
(none)
73
Enrollment
29
Locations
1
Arm
35.6
Anticipated Duration (Months)
2.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Mitoxantrone Hydrochloride Liposome Injection
 Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
73 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-label, Single-arm, Phase II Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced HER2 Negative Breast Cancer
Actual Study Start Date :
Jun 11, 2021
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
May 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

  1. Objective response rate (ORR) [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 Outcome Measures

  1. Disease control rate (DCR) [From the enrollment to the final documentation of response of the last subject(assessed up to 36 months)]

    To investigate the preliminary antitumor efficacy

  2. 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]

    To investigate the preliminary antitumor efficacy

  3. 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]

    To investigate the preliminary antitumor efficacy

  4. Overall survival (OS) [From the enrollment to death,lost to follow-up,withdrawal,or study end,whichever occurred first,assessed up to 36 months]

    To investigate the preliminary antitumor efficacy

  5. Treatment emergent adverse events (TEAEs) [from the administration of the first dose to 28 days after the last dose]

    The incidence and severity of adverse events, abnormalities in physical exams, vital sign assessments, clinical laboratory assessments, ultrasonic cardiograms (UCGs) and electrocardiographs (ECGs).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Voluntarily participate in this study and sign informed consent form;

  2. Male or female patients aged 18 to 75 years (inclusive);

  3. 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);

  4. Patients with unresectable locally advanced or recurrent breast cancer with disease progression after first-line or higher chemotherapy；

  5. Hormone receptor (HR) negative breast cancer or HR-positive breast cancer that is not suitable for endocrine treatment or is resistant to endocrine treatment.

  6. 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；

  7. At least one measurable lesion according to RECIST v1.1;

  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;

  9. 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);

  1. For women of childbearing potential: the serum pregnancy test must be negative, and patients are willing to take adequate contraceptive measures during the treatment period and for at least 6 months after the last dose of the study drug;

  2. Good compliance and willingness to cooperate with follow-up visits.

Exclusion Criteria:

  1. Patients who have severe allergic reactions to mitoxantrone hydrochloride or liposome preparation ingredients;

  2. 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;

  3. Brain metastases and meningeal metastasis;

  4. 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;

  5. Life expectancy < 3 months;

  6. Previous treatment with the anthracyclines, with the total cumulative dose (doxorubicin equivalent) >350 mg/m2;

  7. 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);

  8. 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;

  1. Uncontrollable hypertension (defined as a measured systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg under pharmacological control);

  2. Active bacterial, fungal or viral infections that require intravenous infusion treatment within 1 week prior to the first dose;

  3. Any anticancer treatment (including chemotherapy, radiotherapy, molecular targeted therapy, immunotherapy, endocrine therapy) within 4 weeks prior to the first dose, immunomodulators as adjuvant therapy for malignancy within 2 weeks prior to the first dose, any anti-tumor proprietary Chinese medicine (except for those in the category of supporting and relieving symptoms) within 2 weeks prior to the first dose;

  4. Patients who enrolled in any other clinical trials within 4 weeks prior to the first dose;

  5. Patients who undergone major surgery within 12 weeks before the first dose, or have a surgical schedule during the study period;

  6. Patients with thrombosis or thromboembolism within 6 months prior to screening;

  7. Lactating female;

  8. Serious and/or uncontrolled medical condition that, in the judgment of the investigator, may affect the patient's participation in this study (including, but not limited to: diabetes not effectively controlled, kidney disease requiring dialysis, severe liver disease, life-threatening autoimmune and bleeding disorders, substance abuse, neurological disorders, etc.);

  9. Not suitable for this study as decided by the investigator due to other reasons.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anhui Provincial Hospical Hefei Anhui China 230000
2 Cancer Center Sun Yat-sen University Guozhou Guodong China 510060
3 Affiliated Hospital of Hebei University Baoding Hebei China 071030
4 The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei China 050000
5 Tangshan People's Hospital Tangshan Hebei China 063000
6 Xingtai People's Hospital Xingtai Hebei China 054000
7 Harbin Medical University Cancer Hospital Harbin Heilongjiang China 150008
8 Daqing People's Hospital Daqing Helongjiang China 163316
9 Cancer Hospital of Jiamusi City Jiamusi Helongjiang China 154007
10 The First Affiliated Hospital of Xinxiang Medical University Xinxiang Henan China 453100
11 Cancer Hospital of Henan Province Zhengzhou Henan China 450008
12 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450052
13 Henan Provincial People's Hospital Zhenzhou Henan China 450008
14 Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei China 430022
15 Zhongnan Hospital of Wuhan University Wuhan Hubei China 430071
16 Hubei Cancer Hospital Wuhan Hubei China 430079
17 Changsha Kexin Cancer Hospital Changsha Hunan China 413002
18 Yiyang Central Hospital Yiyang Hunan China 413002
19 The third Hospital of Nanchang Nanchang Jiangxi China 330000
20 The second hospital of Jinlin University Changchun Jinlin China 130041
21 The second hospital of Dalian Medical University Dalian Liaoning China 116023
22 The First Affiliated Hospital of Jinzhou Medical University Jinzhou Liaoning China 121000
23 The First hospital of China Medical University Shenyang Liaoning China 110000
24 Shanxi Provincial Cancer Hospital Taiyuan Shanxi China 0300001
25 Yuncheng Central Hospital Yuncheng Shanxi China 044000
26 Sichuan Cancer Hospital & Institute Chengdu Sichuan China 610041
27 The second people's hospital of neijiang Neijiang Sichuan China 641100
28 Affiliated tumor Hospital of Xinjiang Medical University Urumqi Xinjiang China 830011
29 The First Affiliated Hospital of Xinjiang Medical University Urumqi Xinjiang China 830011

Sponsors and Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Investigators

  • Principal Investigator: qingyuan zhang, PhD, Harbin Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04927481
Other Study ID Numbers:
  • HE071-CSP-021
First Posted:
Jun 16, 2021
Last Update Posted:
Jun 16, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms
Mitoxantrone

Study Results

No Results Posted as of Jun 16, 2021