Sacituzumab Govitecan in Chinese Patients With mTNBC of at Least 2 Prior Treatments
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|ClinicalTrials.gov Identifier: NCT04454437|
Recruitment Status : Not yet recruiting
First Posted : July 1, 2020
Last Update Posted : July 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Triple-negative Breast Cancer||Biological: Sacituzumab Govitecan||Phase 2|
This is a Phase IIb, single arm, multicenter study of sacituzumab govitecan in locally advanced or metastatic TNBC patients who are refractory or relapsing after at least 2 prior standard chemotherapy regimens for unresectable, locally advanced or metastatic breast cancer, and these regimens will qualify regardless of triple-negative status at the time they were given. The primary endpoint of the trial will be the ORR per RECIST v 1.1 by Independent Review Committee (IRC) in all treated patients.
Patients will be treated until progression requiring discontinuation of further treatment, unacceptable toxicity, study withdrawal, or death, whichever comes first. Tumor response and progression will be assessed using RECIST v 1.1 and assessment by Investigator at the trial center will be sufficient for decisions on continuation of treatment. An independent analysis of response will also be performed by IRC, but this will not be used to make treatment decisions. All patients will visit the Investigator at regular intervals for assessment of safety parameters and AEs.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IIb, Single Arm, Multicenter Trial of Sacituzumab Govitecan in Chinese Patients With Metastatic Triple-negative Breast Cancer Who Received at Least Two Prior Treatments|
|Estimated Study Start Date :||July 3, 2020|
|Estimated Primary Completion Date :||October 31, 2021|
|Estimated Study Completion Date :||November 27, 2022|
Biological: Sacituzumab Govitecan
10 mg/kg intravenously on Days 1 and 8 of a 21-day cycleNA. Number of Cycles: until disease progression or intolerable toxicity or consent withdrawal for any reason.
- Objective response rate (ORR) by IRC according to RECIST v 1.1 [ Time Frame: 3 years ]
- Duration of response [DOR] by Independent Review Committee (IRC) [ Time Frame: 3 years ]Defined as the time between the date when response is first observed until the earlier date of disease progression or death.
- Clinical benefit rate [CBR] [ Time Frame: 3 years ]Includes CR, PR and stable disease (SD) of at least 6 months.
- Progression-free survival [PFS] [ Time Frame: 3 years ]Defined as the time since the first dose of trial treatment until the earlier date of disease progression or death
- Overall survival [OS] [ Time Frame: 3 years ]Defined as the time since the first dose of trial treatment until death
- Safety and tolerability [ Time Frame: 3 years ]AEs, serious adverse events [SAEs] according to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 [NCI-CTCAE v 5.0]
- PK parameters; T1/2 [ Time Frame: 3 years ]
- PK parameters; AUC0-168h [ Time Frame: 3 years ]
- PK parameters; Cmax [ Time Frame: 3 years ]
- Anti-drug antibody [ Time Frame: 3 years ]If ADA is positive or negative during treatment, and ADA titer if positive
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): NCT04454437
|Contact: Zhai Qingbo||86 185 0210 email@example.com|
|Principal Investigator:||Binghe Xu, MD||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|