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).
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
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 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.
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
MTD of mitoxantrone hydrochloride liposome
To evaluate the tolerability of mitoxantrone hydrochloride liposome combination regime
Time frame: At the end of Cycle 1 (each cycle is 21 days or 28 days)
Safety: Hematologic and non-hematologic toxicities (NCI CTCAE v5.0)
To identify the incidence of AE and SAE in clinical trial
Time frame: 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
Time frame: 21 or 28 days after the last dose
Disease control rate (DCR)
To evaluate the efficacy of anti-tumor
Time frame: 21 or 28 days after the last dose
Progression-free survival (PFS)
To evaluate the efficacy of anti-tumor
Time frame: one year after the last dose
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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.