Status:
UNKNOWN
Mitoxantrone Hydrochloride Liposome Combined With Capecitabine in Patients With HER-2 Negative Advanced Breast Cancer
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsors:
CSPC Ouyi Pharmaceutical Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief 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 tr...
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 bre...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
November 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06156761
Start Date
November 28 2023
End Date
April 1 2025
Last Update
December 5 2023
Active Locations (1)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China