RC48-ADC Administered Intravenously to Subjects With HER2-Positive in Advanced Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03052634|
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : March 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Breast Cancer||Drug: RC48-ADC Drug: Lapatinib plus capecitabine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The Intervention Model of phase Ib is single group assignment，however ，The Intervention Model of phase II is parallel group assignment.The Experimental of The phase II is RC48-ADC, and the active comparator of RC48-ADC is lapatinib plus capecitabine|
|Masking:||None (Open Label)|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||December 2020|
Phase Ib: Patients will receive RC48-ADC 1.5 mg/kg or 2.0mg/kg or 2.5mg/kg intravenously (IV) administered once every 2 weeks.
Phase II: Patients will receive a suitable RC48-ADC dose which was selected according to the Ib phase of the experimental results RC48-ADC via IV administered once every 2 weeks.
Other Name: ADC=Antibody-drug conjugates
Active Comparator: Lapatinib plus capecitabine
Phase II： Active Comparator:Lapatinib+capecitabine Lapatinib repeating dose taken orally every day for 3 weeks as a treatment cycle.
Capecitabine :1000 mg/m2 bid, oral. Days: 1-14 every three weeks.
Drug: Lapatinib plus capecitabine
- Progression Free Survival (PFS) [ Time Frame: Estimated 2 year ]Progression-free survival (PFS) was defined as the time from the first day of study treatment (Day 1) to first documented disease progression or death, whichever occurred first. If a patient did not experience disease progression or die, PFS was censored at the day of the last tumor assessment that a patient was known to be progression free.
- Cmax [ Time Frame: Estimated 2 year ]Maximum Observed Plasma Concentration
- AUC [ Time Frame: Estimated 2 year ]Area Under Curve
- Tmax [ Time Frame: Estimated 2 year ]Time for Cmax
- Overall response Rate (ORR) [ Time Frame: Estimated 2 year ]As per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - to estimate the anti-tumor activity of RC48-ADC.
- Clinical Benefit Rate (CBR) [ Time Frame: Estimated 2 year ]Clinical Benefit Rate was defined as the percentage of patients with complete remission (CR) partial remission (PR) stable (SD) not less than 4 months.
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): NCT03052634
|Contact: Lin Lifirstname.lastname@example.org|
|Cancer Hospital Chinese Academy of Medical Sciences||Recruiting|
|Beijing, Beijing, China, 100021|