Breast CancerNCT06156761
Mitoxantrone Hydrochloride Liposome Combined With Capecitabine in Patients With HER-2 Negative Advanced Breast Cancer
A study testing Mitoxantrone hydrochloride liposome and Capecitabine in people with Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
To evaluate the dose-limiting toxicity of mitoxantrone hydrochloride liposome combined with capecitabine in patients with HER-2 negative advanced breast cancer who have received at least first-line treatment, explore the maximum tolerated dose (MTD) of mitoxantrone hydrochloride liposome, and determine the recommended… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mitoxantrone hydrochloride liposome and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 28 Nov 2023to Apr 2025
- Phase
- Interventional
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients fully understand and voluntarily participate in this study and sign the informed consent form.
- Age ≥18 and ≤70 years, Female.
- Histopathologically confirmed HER-2 negative breast cancer (Immunohistochemical HER-2 0/1+ or immunohistochemical HER-2 2+ that had to be confirmed as negative by in situ hybridization).
- Hormone receptor (HR) negative, HR positive but ineligible for endocrine therapy, or HR positive but resistant to endocrine therapy.
- Recurrent or metastatic breast cancer that have failed at least one line of chemotherapy or ADC. And previous endocrine therapy was not counted.
- Previous treatment with taxanes and/or anthracyclines.
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- Relapse occurred no less than 12 months after the last dose of an anthracycline-containing adjuvant chemotherapy regimen.
- Have at least one measurable disease according to RECIST 1.1.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-1.
- LVEF≥50%.
- Good bone marrow function (no blood transfusion or growth factor support within 2 weeks before the first dose of trial medication): WBC≥3.0×10^9/L, ANC ≥1.5×10^9/L, PLT ≥75×10^9/L, Hb≥90g/L.
- Pregnancy tests were negative, and patients of childbearing age committed to use effective contraception or abstinence from sex from the start of the study until 6 months after the last study dose.
- Expected survival time greater than 3 months.
- Good compliance and willingness to cooperate with follow-up visits.
Who cannot join
- Patients have one of the following conditions in the previous anti-tumor treatments:
- Previous treatment with mitoxantrone or mitoxantrone liposome:
- Previous treatment with doxorubicin or epirubicin (total cumulative dose of doxorubicin>350mg/m^2, total cumulative dose of epirubicin>700mg/m^2);
- Has received anti-tumor treatment (including chemotherapy, targeted therapy, hormone therapy, taking traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received clinical trial drugs within 4 weeks before the first use of the study drugs.
- Abnormal heart function, including:
- Long QTc syndrome or QTc interval > 480ms;
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- Complete left bundle branch block, degree II or III atrioventricular block;
- Severe, uncontrolled arrhythmias requiring medical treatment;
- New York Heart Association grade ≥ II;
- A history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically significant pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment.
- Previous or current concurrent malignancy other than breast cancer.
- Have any serious and/or uncontrolled medical conditions that in the judgment of the investigator may affect the patient's participation in the study (including advanced infection, uncontrolled diabetes or hypertension, severe liver disease, etc.).
- Have uncontrolled brain metastases.
- Chronic hepatitis B (HBsAg or HBcAb positive and HBV DNA≥1000IU/mL), chronic hepatitis C (HCV antibody positive and HCV RNA higher than the lower limit of the detection value of the research center), or HIV antibody positive.
- Participants who are known to be allergic to the active or other components of the study treatment.
- Pregnant or lactating women.
- A history of severe neurological or psychiatric illness.
- Participants who were judged by the investigator to be unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Binghe Xu, PHD, 86-10-87788495, xubinghe@medmail.com.cn
Qiao Li, MD, 86-10-87788120, liqiaopumc@qq.com
About this study
Official title: Clinical Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Capecitabine in Patients With HER-2 Negative Advanced Breast Cancer
To evaluate the dose-limiting toxicity of mitoxantrone hydrochloride liposome combined with capecitabine in patients with HER-2 negative advanced breast cancer who have received at least first-line treatment, explore the maximum tolerated dose (MTD) of mitoxantrone hydrochloride liposome, and determine the recommended phase II dose (RP2D).
Read the detailed description
This is a single-center, open-label, phase I dose-increasing study following the "3+3" principle, which planned to enroll a maximum of 48 clinically confirmed patients with advanced HER-2 negative breast cancer who have received at least first-line treatment, to explore the MTD of mitoxantrone hydrochloride liposome.
- Conditions
- Breast Cancer
- Being tested
- Mitoxantrone hydrochloride liposome, Capecitabine
- 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 liposomeDrug
Drug: Mitoxantrone hydrochloride liposome (16 mg/m^2, 18 mg/m^2, 20 mg/m^2 and 22 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
CapecitabineDrug
Capecitabine (1000 mg/m^2) will be administered orally in a 3-week treatment cycle, twice a day from day 1 to day 14 of each cycle.
Mitoxantrone hydrochloride liposomeDrug
Mitoxantrone hydrochloride liposome (16 mg/m^2, 18 mg/m^2, 20 mg/m^2 and 22 mg/m^2) will be administered by intravenous infusion on day 1 in a 4-week treatment cycle.
CapecitabineDrug
Capecitabine (825 mg/m^2) will be administered orally in a 4-week treatment cycle, twice a day from day 1 to day 21 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 3-week arm | Experimental | Patients will receive mitoxantrone hydrochloride liposome combined with capecitabine therapy in a 3-week treatment cycle. Receives: Drug: Mitoxantrone hydrochloride liposome; Drug: Capecitabine |
| Experimental: 4-week arm | Experimental | Patients will receive mitoxantrone hydrochloride liposome combined with capecitabine therapy in a 4-week treatment cycle. Receives: Drug: Mitoxantrone hydrochloride liposome; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD of mitoxantrone hydrochloride liposome
To evaluate the tolerability of mitoxantrone hydrochloride liposome combination regime
Measured: At the end of Cycle 1 (each cycle is 21 days or 28 days)
Secondary outcomes (4)
Safety: Hematologic and non-hematologic toxicities (NCI CTCAE v5.0)
To identify the incidence of AE and SAE in clinical trial
Measured: From the initiation of the first dose to 21 or 28 days after the last dose
Objective response rate (ORR)
To evaluate the efficacy of anti-tumor
Measured: 21 or 28 days after the last dose
Disease control rate (DCR)
To evaluate the efficacy of anti-tumor
Measured: 21 or 28 days after the last dose
Progression-free survival (PFS)
To evaluate the efficacy of anti-tumor
Measured: one year 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.
- First posted5 Dec 2023
- Study start28 Nov 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2025 (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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Binghe Xu, PHD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156761
- Sponsor's protocol ID
- CSPC-DED-BC-K01
- Status last verified
- Dec 2023
- First submitted
- 20 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu J, Jiang M, Zhang M, Zhou S, Li M, Shi X, Li L, Yang X, Li P, Tian M, Ma F, Xu B, Li Q. Mitoxantrone hydrochloride liposome (Lipo-MIT) combined with capecitabine in HER2-negative advanced breast cancer: a dose-escalation, phase I study. BMC Med. 2026 Apr 28;24(1):356. doi: 10.1186/s12916-026-04895-9.
PubMed 42050512
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Capecitabine in Patients With HER-2 Negative Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT06156761
- Acronym / sponsor ID
- CSPC-DED-BC-K01
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 28 Nov 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 5 Dec 2023 (actual)
- 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.
To evaluate the dose-limiting toxicity of mitoxantrone hydrochloride liposome combined with capecitabine in patients with HER-2 negative advanced breast cancer who have received at least first-line treatment, explore the maximum tolerated dose (MTD) of mitoxantrone hydrochloride liposome, and determine the recommended phase II dose (RP2D).
Detailed description
This is a single-center, open-label, phase I dose-increasing study following the "3+3" principle, which planned to enroll a maximum of 48 clinically confirmed patients with advanced HER-2 negative breast cancer who have received at least first-line treatment, to explore the MTD of mitoxantrone hydrochloride liposome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: 3-week arm | Experimental | Drug: Mitoxantrone hydrochloride liposome, Drug: CapecitabinePatients will receive mitoxantrone hydrochloride liposome combined with capecitabine therapy in a 3-week treatment cycle. |
| Experimental: 4-week arm | Experimental | Drug: Mitoxantrone hydrochloride liposome, Drug: CapecitabinePatients will receive mitoxantrone hydrochloride liposome combined with capecitabine therapy in a 4-week treatment cycle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients fully understand and voluntarily participate in this study and sign the informed consent form.
- Age ≥18 and ≤70 years, Female.
- Histopathologically confirmed HER-2 negative breast cancer (Immunohistochemical HER-2 0/1+ or immunohistochemical HER-2 2+ that had to be confirmed as negative by in situ hybridization).
- Hormone receptor (HR) negative, HR positive but ineligible for endocrine therapy, or HR positive but resistant to endocrine therapy.
- Recurrent or metastatic breast cancer that have failed at least one line of chemotherapy or ADC. And previous endocrine therapy was not counted.
Key exclusion criteria (18 listed)
- Patients have one of the following conditions in the previous anti-tumor treatments:
- Abnormal heart function, including:
- Previous or current concurrent malignancy other than breast cancer.
- Have any serious and/or uncontrolled medical conditions that in the judgment of the investigator may affect the patient's participation in the study (including advanced infection, uncontrolled diabetes or hypertension, severe liver disease, etc.).
- Have uncontrolled brain metastases.
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 liposomeDrug: Mitoxantrone hydrochloride liposome (16 mg/m^2, 18 mg/m^2, 20 mg/m^2 and 22 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle. | Drug | Experimental: 3-week arm |
| CapecitabineCapecitabine (1000 mg/m^2) will be administered orally in a 3-week treatment cycle, twice a day from day 1 to day 14 of each cycle. | Drug | Experimental: 3-week arm |
| Mitoxantrone hydrochloride liposomeMitoxantrone hydrochloride liposome (16 mg/m^2, 18 mg/m^2, 20 mg/m^2 and 22 mg/m^2) will be administered by intravenous infusion on day 1 in a 4-week treatment cycle. | Drug | Experimental: 4-week arm |
| CapecitabineCapecitabine (825 mg/m^2) will be administered orally in a 4-week treatment cycle, twice a day from day 1 to day 21 of each cycle. | Drug | Experimental: 4-week arm |
Primary outcome
MTD of mitoxantrone hydrochloride liposome
Time frame: At the end of Cycle 1 (each cycle is 21 days or 28 days)
To evaluate the tolerability of mitoxantrone hydrochloride liposome combination regime
4 secondary outcomes
Safety: Hematologic and non-hematologic toxicities (NCI CTCAE v5.0)
Time frame: From the initiation of the first dose to 21 or 28 days after the last dose
Objective response rate (ORR)
Time frame: 21 or 28 days after the last dose
Disease control rate (DCR)
Time frame: 21 or 28 days after the last dose
Progression-free survival (PFS)
Time frame: one year after the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Derived from this study: PubMed 42050512Liu J, Jiang M, Zhang M, Zhou S, Li M, Shi X, Li L, Yang X, Li P, Tian M, Ma F, Xu B, Li Q. Mitoxantrone hydrochloride liposome (Lipo-MIT) combined with capecitabine in HER2-negative advanced breast cancer: a dose-escalation, phase I study. BMC Med. 2026 Apr 28;24(1):356. doi: 10.1186/s12916-026-04895-9.
- Individual participant dataSharing planned: No
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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.
Binghe Xu, PHD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitoxantrone hydrochloride liposome and Capecitabine in people with Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 14 inclusion and 18 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 5 Dec 2023. 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.
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 Binghe Xu, PHD (86-10-87788495, xubinghe@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD of mitoxantrone hydrochloride liposome (time frame: At the end of Cycle 1 (each cycle is 21 days or 28 days)). 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 NCT06156761, 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 5 Dec 2023.