Mitoxantrone Hydrochloride Liposome Combined With Capecitabine in Patients With HER-2 Negative Advanced Breast Cancer

NCT06156761 | Unknown

• 1 other identifier: CSPC-DED-BC-K01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 treatment, explore the maximum tolerated dose (MTD) of mitoxantrone hydrochloride liposome, and determine the recommended phase II dose (RP2D).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• MTD of mitoxantrone hydrochloride liposome

  To evaluate the tolerability of mitoxantrone hydrochloride liposome combination regime

  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)

  From the initiation of the first dose to 21 or 28 days after the last dose

• Objective response rate (ORR)

  21 or 28 days after the last dose

• Disease control rate (DCR)

  21 or 28 days after the last dose

• Progression-free survival (PFS)

  one year after the last dose

Study Arms (2)

Experimental: 3-week arm

EXPERIMENTAL

Patients will receive mitoxantrone hydrochloride liposome combined with capecitabine therapy in a 3-week treatment cycle.

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.

Drug: Mitoxantrone hydrochloride liposome; Drug: Capecitabine

Interventions

Mitoxantrone hydrochloride liposome DRUG

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.

Experimental: 3-week arm

Capecitabine DRUG

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.

Experimental: 3-week arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• CSPC Ouyi Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Binghe Xu, PHD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Binghe Xu, PHD

CONTACT

86-10-87788495; xubinghe@medmail.com.cn

Qiao Li, MD

CONTACT

86-10-87788120; liqiaopumc@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 5, 2023
• Study Start: November 28, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2025
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)