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continue until radiographic evidence indicates disease progression, intolerable toxicity occurs, informed consent is withdrawn, or the investigator decides to discontinue treatment.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.
Age ≥18 years old，and ≤70 years old.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Expected survival period not less than 12 weeks.
At least 1 measurable lesion according to RECIST 1.1 standard.
There is a third interstitial fluid accumulation that cannot be controlled by drainage or other methods (such as a large amount of hydrothorax and ascites).
Symptomatic or uncontrolled brain or meningeal metastases.
Patients with only bone or skin metastasis as the assessable lesion.
Previously suffered from other malignant tumors.
Single group
Pegylated Liposomal Doxorubicin + vinorelbine,every cycle is 14d.
DrugPegylated 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.
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.
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.
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.
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.
treatment-related adverse events (TRAE)
TRAE is defined as the adverse reactions that occur during the use of medication for treatment and are supposed to be related to the intervention drugs.
quality of life (QoL)
QoL assessment is examined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30), of which 30 items were included. Items 1-28 are divided into 4 levels, with ratings ranging from 1 to 4 (the higher score indicates worse life quality). Items 29 and 30 are divided into 7 levels, with ratings ranging from 1 to 7 (the higher score indicates better life quality).
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Wang Jiayu
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor institution
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborator
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