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Breast CancerPhase 2NCT04927481

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

A Phase 2 study testing Mitoxantrone Hydrochloride Liposome Injection in people with Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 29 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Breast Cancer
What is being tested?
Mitoxantrone Hydrochloride Liposome Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
29 sitesChina
Study dates
11 Jun 2021to 17 Jan 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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；
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  • 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);
  • 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;
  • Good compliance and willingness to cooperate with follow-up visits.

Who cannot join

  • 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;
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  • 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;
  • Uncontrollable hypertension (defined as a measured systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg under pharmacological control);
  • Active bacterial, fungal or viral infections that require intravenous infusion treatment within 1 week prior to the first dose;
  • 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;
  • Patients who enrolled in any other clinical trials within 4 weeks prior to the first dose;
  • Patients who undergone major surgery within 12 weeks before the first dose, or have a surgical schedule during the study period;
  • Patients with thrombosis or thromboembolism within 6 months prior to screening;
  • Lactating female;
  • 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.);
  • Not suitable for this study as decided by the investigator due to other reasons.

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

China29 sites

  • Affiliated Hospital of Hebei University

    Baoding, Hebei, 071030

  • The second hospital of Jinlin University

    Changchun, Jinlin, 130041

  • Changsha Kexin Cancer Hospital

    Changsha, Hunan, 413002

  • Sichuan Cancer Hospital & Institute

    Chengdu, Sichuan, 610041

  • The second hospital of Dalian Medical University

    Dalian, Liaoning, 116023

  • Daqing People's Hospital

    Daqing, Helongjiang, 163316

  • Cancer Center Sun Yat-sen University

    Guozhou, Guodong, 510060

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150008

  • Anhui Provincial Hospical

    Hefei, Anhui, 230000

  • Cancer Hospital of Jiamusi City

    Jiamusi, Helongjiang, 154007

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning, 121000

  • The third Hospital of Nanchang

    Nanchang, Jiangxi, 330000

  • The second people's hospital of neijiang

    Neijiang, Sichuan, 641100

  • The First hospital of China Medical University

    Shenyang, Liaoning, 110000

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 0300001

  • Tangshan People's Hospital

    Tangshan, Hebei, 063000

  • Affiliated tumor Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830011

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830011

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

    Wuhan, Hubei, 430022

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • Xingtai People's Hospital

    Xingtai, Hebei, 054000

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453100

  • Yiyang Central Hospital

    Yiyang, Hunan, 413002

  • Yuncheng Central Hospital

    Yuncheng, Shanxi, 044000

  • Cancer Hospital of Henan Province

    Zhengzhou, Henan, 450008

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • Henan Provincial People's Hospital

    Zhenzhou, Henan, 450008

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Being tested
Mitoxantrone Hydrochloride Liposome Injection
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mitoxantrone Hydrochloride Liposome InjectionDrug

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

Study groups in NCT04927481
Study groupRoleWhat they receive
Mitoxantrone Hydrochloride Liposome InjectionExperimentalPatients with advanced HER2 negative breast cancer will receive 20 mg/m2 Mitoxantrone Hydrochloride Liposome injection every 21 days (a cycle) for about 6 cycles.
Receives: Drug: Mitoxantrone Hydrochloride Liposome Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    To investigate the preliminary antitumor efficacy

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

Secondary outcomes (5)

  1. Disease control rate (DCR)

    To investigate the preliminary antitumor efficacy

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

  2. Duration of response (DoR)

    To investigate the preliminary antitumor efficacy

    Measured: From the enrollment to death,lost to follow-up,withdrawal,or study end,whichever occurred first,assessed up to 36 months

  3. Progression-free survival (PFS)

    To investigate the preliminary antitumor efficacy

    Measured: From the enrollment to death,lost to follow-up,withdrawal,or study end,whichever occurred first,assessed up to 36 months

  4. Overall survival (OS)

    To investigate the preliminary antitumor efficacy

    Measured: From the enrollment to death,lost to follow-up,withdrawal,or study end,whichever occurred first,assessed up to 36 months

  5. Treatment emergent adverse events (TEAEs)

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

    Measured: from the administration of the first dose to 28 days after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2021
  2. Study start11 Jun 2021
  3. Primary completion17 Jan 2023
  4. Study completion17 Jan 2023

Why it stopped: The sponsor has adjusted its R\&D strategy.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04927481
Sponsor's protocol ID
HE071-CSP-021
Status last verified
Feb 2024
First submitted
31 May 2021
Last updated
23 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mitoxantrone Hydrochloride Liposome Injection in people with Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 29 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The sponsor has adjusted its R\&D strategy.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: From the enrollment to the final documentation of response of the last subject(assessed up to 36 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04927481.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.

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