A Phase 2 interventional study of Pegylated Liposomal Doxorubicin + vinorelbine,every cycle is 14d. in Her2-negative Metastatic Breast Cancer, Vinorelbine and Liposomal Doxorubicin, sponsored by Wang Jiayu. Not yet recruiting. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-10-23.
Sponsored by Wang Jiayu · Phase 2, Interventional, and Treatment
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continue until radiographic evidence indicates disease progression, intolerable toxicity occurs, informed consent is withdrawn, or the investigator decides to discontinue treatment.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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 30 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Wang Jiayu is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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. Blood Routine
. Blood Biochemistry
. Echocardiogram
. electrocardiogram
The QT interval (QTcF) corrected by Fridericia method less than 450 ms for male and less than 470 ms for female.
Exclusion Criteria:
Pegylated Liposomal Doxorubicin 25mg/m2 ivgtt d1 + vinorelbine25mg/m2 ivgtt d1/q14d.
Drug: Pegylated Liposomal Doxorubicin + vinorelbine,every cycle is 14d.
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.
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.
Time frame: Adverse events will be assessed every cycle (each cycle is 14 days) and graded according to the Common Terminology Criteria Adverse Events (CTCAE) version 5 until 1 month after the end of treatment.
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).
Time frame: The life quality questionnaire is arranged at baseline and every 3 months after enrollment until 6 months after the end of treatment.
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
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Wang Jiayu