With advancements in various treatment modalities, the survival of breast cancer patients has continuously improved. Patients with advanced breast cancer who have undergone multiple lines of therapy still have treatment options, but standard treatment protocols are lacking. Anthracyclines are a cornerstone in breast cancer treatment; however, their cumulative dose-related cardiac toxicity limits their use. Liposomal doxorubicin exhibits comparable efficacy to conventional anthracyclines and is not affected by previous cumulative doses. The combination of vinorelbine with liposomal doxorubicin shows reduced cross-toxicity, and several studies have demonstrated the effectiveness of this regimen in metastatic HER2-negative breast cancer patients. Therefore, we aim to explore whether optimizing the dosage and treatment cycle of this combination therapy can provide a viable treatment option for metastatic HER2-negative breast cancer patients who have previously received second-line or higher chemotherapy, seeking a regimen that balances efficacy and safety. This study is a single-center, single-arm Phase II clinical trial planned to enroll 30 metastatic HER2-negative breast cancer patients who have previously undergone second-line or higher chemotherapy. Participants will receive an optimized regimen of liposomal doxorubicin combined with vinorelbine, with safety assessed every cycle and efficacy evaluated every three cycles. Treatment will continue until radiographic evidence indicates disease progression, intolerable toxicity occurs, informed consent is withdrawn, or the investigator decides to discontinue treatment. Following treatment, each participant will undergo survival follow-up every three months until death, loss to follow-up, or withdrawal of consent.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Pegylated Liposomal Doxorubicin 25mg/m2 ivgtt d1 + vinorelbine25mg/m2 ivgtt d1/q14d.
progression-free survival (PFS)
PFS is defined as the time from randomization to the date of confirmed radiological progression or death from any cause.
Time frame: Radiological examinations will be conducted every three cycles: at the end of Cycle 3, 6, 9,...(each cycle is 14 days). The PFS will last until disease progression,up to 2 years.
overall survival (OS)
OS is defined as the time from randomization to the date of death from any cause and censored at the date of final contact for patients who were still alive.
Time frame: The long-time survival will be followed every 3 months after the end of treatment,up to 5 years.
objective response rate (ORR)
ORR is defined as the proportion of patients with best response of complete response (CR) and partial response (PR) according to RECIST 1.1 standard.
Time frame: Time Frame: Radiological examinations will be conducted every three cycles: at the end of Cycle 3, 6, 9, ......(each cycle is 14 days),assessed until cycle 15 . The efficacy will be evaluated according to RECIST 1.1 standard.
clinical benefit rate (CBR)
CBR is defined as the proportion of patients with best response of complete response (CR) , partial response (PR) and stable disease (SD) according to RECIST 1.1 standard.
Time frame: Radiological examinations will be conducted every three cycles,at the end of cycle 3,6,9... (each cycle is 14 days).The efficacy will be evaluated according to RECIST 1.1 standard.
Disease Control Rate(DCR)
It is defined as the proportion of patients who achieve either a complete response (CR), a partial response (PR), or stable disease (SD) after treatment.
Time frame: Radiological examinations will be conducted every three cycles,at the end of cycle 3,6,9... (each cycle is 14 days).The efficacy will be evaluated according to RECIST 1.1 standard.
Time to Progression(TTP)
It is the duration from the start of treatment until the disease shows signs of progression, such as tumor growth or the emergence of new lesions.
Time frame: Radiological examinations will be conducted every three cycles: at the end of Cycle 3, 6, 9......(each cycle is 14 days). The TTP will last until disease progression,up to 2 years.
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