Advanced Recurrent or Metastatic Breast CancerPhase 2NCT02596373
A Study of Mitoxantrone Hydrochloride Liposome Injection in Advanced Recurrent or Metastatic Breast Cancer
A Phase 2 study testing Mitoxantrone Hydrochloride Liposome Injection in people with Advanced Recurrent or Metastatic Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced Recurrent or Metastatic 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
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Sep 2018
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Hospital
Shanghai
Xichun Hu, Ph.D, +8613816110335, xchu2009@hotmail.com
Xichun Hu, Ph.D
About this study
Official title: A Randomized, Open-label, Positive-controlled, Single-institutional, Phase Ⅱ of Mitoxantrone Hydrochloride Liposome Injection in Advanced Recurrent or Metastatic Breast Cancer
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
Read the 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.
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Mitoxantrone Hydrochloride Liposome Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR(Objective reponse rate)
Measured: 4-8 Months
Secondary outcomes (1)
PFS(Progression free survival)
Measured: 2.5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2018
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Recurrent or Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xichun Hu, Ph.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596373
- Sponsor's protocol ID
- CSPC-HE1506/PRO/Ⅰ
- Status last verified
- Aug 2018
- First submitted
- 2 Nov 2015
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34633576
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Positive-controlled, Single-institutional, Phase Ⅱ of Mitoxantrone Hydrochloride Liposome Injection in Advanced Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT02596373
- Acronym / sponsor ID
- CSPC-HE1506/PRO/Ⅰ
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Sep 2018 (estimated)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome Injection | Experimental | Drug: Mitoxantrone Hydrochloride Liposome InjectionMitoxantrone 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 |
| Mitoxantrone Hydrochloride Injection | Active comparator | Drug: Mitoxantrone Hydrochloride Liposome InjectionMitoxantrone 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome Injection | Drug | Mitoxantrone Hydrochloride Injection, Mitoxantrone Hydrochloride Liposome Injection |
Primary outcome
ORR(Objective reponse rate)
Time frame: 4-8 Months
1 secondary outcome
PFS(Progression free survival)
Time frame: 2.5 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Derived from this study: PubMed 34633576Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xichun Hu, Ph.D principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mitoxantrone Hydrochloride Liposome Injection in people with Advanced Recurrent or Metastatic Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site 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 12 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xichun Hu, Ph.D (+8613816110335, xchu2009@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR(Objective reponse rate) (time frame: 4-8 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 NCT02596373, which also lists 1 linked publication.
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 17 Aug 2018.