| 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 |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
|
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
|
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: peng yuan, Prof | 13501270834 ext 13501270834 | yuanpeng01@hotmail.com |
| China, Beijing | |
| Peng Yuan | Recruiting |
| Beijing, Beijing, China, 100021 | |
| Contact: peng yuan, Prof 13501270834 ext 13501270834 yuanpeng01@hotmail.com | |
| Contact: xue wang, Dr 13811967690 ext 13501270834 wxyxuki@163.com | |
| Principal Investigator: | peng yuan | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 29, 2019 | ||||
| First Posted Date ICMJE | May 1, 2019 | ||||
| Last Update Posted Date | July 8, 2020 | ||||
| Actual Study Start Date ICMJE | March 11, 2019 | ||||
| Estimated Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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)
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Phase Ⅱ Study of Pegylated Liposomal Doxorubicin(PLD)Plus Trastuzumab in HER-2 Positive Metastatic Breast Cancer | ||||
| Official Title ICMJE | Phase Ⅱ Study of Pegylated Liposomal Doxorubicin(PLD)Plus Trastuzumab in HER-2 Positive Metastatic Breast Cancer | ||||
| Brief Summary | This is a single-center phase Ⅱ study designed to evaluated the efficacy and safety of pegylated liposomal doxorubicin(PLD)in combination with trastuzumab in HER-2 positive metastatic breast cancer . | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | HER2-positive Breast Cancer | ||||
| Intervention ICMJE | Drug: pegylated liposomal doxorubicin
Eligible patients will be treated with the PLD+trastuzumab regimen until the disease progresses or intolerable toxicity
|
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| Study Arms ICMJE | 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. Intervention: Drug: pegylated liposomal doxorubicin
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
30 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | May 1, 2022 | ||||
| Estimated Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03933319 | ||||
| Other Study ID Numbers ICMJE | CSPC-DMS-BC-11 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Peng Yuan, Chinese Academy of Medical Sciences | ||||
| Study Sponsor ICMJE | Chinese Academy of Medical Sciences | ||||
| Collaborators ICMJE | CSPC Ouyi Pharmaceutical Co., Ltd. | ||||
| Investigators ICMJE |
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| PRS Account | Chinese Academy of Medical Sciences | ||||
| Verification Date | July 2020 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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