Phase Ⅱ Study of Pegylated Liposomal Doxorubicin（PLD）Plus Trastuzumab in HER-2 Positive Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03933319|
Recruitment Status : Unknown
Verified July 2020 by Peng Yuan, Chinese Academy of Medical Sciences.
Recruitment status was: Recruiting
First Posted : May 1, 2019
Last Update Posted : July 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|HER2-positive Breast Cancer||Drug: pegylated liposomal doxorubicin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ⅱ Study of Pegylated Liposomal Doxorubicin（PLD）Plus Trastuzumab in HER-2 Positive Metastatic Breast Cancer|
|Actual Study Start Date :||March 11, 2019|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||May 1, 2022|
Experimental: PLD in combination with trastuzumab
Trastuzumab: administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg once every 21 days.
pegylated liposomal doxorubicin(PLD):administered at dose of 35mg/m2 IV once every 21 days.
Drug: pegylated liposomal doxorubicin
Eligible patients will be treated with the PLD+trastuzumab regimen until the disease progresses or intolerable toxicity
- Objective response rate (ORR) [ Time Frame: approximately 6 months ]The ORR will be calculated as the proportion of patients in the Efficacy Evaluable Patient Set who achieve complete response (CR) and partial response (PR)
- Progression-free survival (PFS) [ Time Frame: approximately 1.5 years ]PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause
- Incidence and Severity of adverse events [ Time Frame: approximately 1.5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933319
|Contact: peng yuan, Prof||13501270834 ext firstname.lastname@example.org|
|Principal Investigator:||peng yuan||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|