Safety and Efficacy of SCT200 in Patients With Relapsed or Metastatic Triple Receptor Negative Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03692689|
Recruitment Status : Unknown
Verified March 2018 by Sinocelltech Ltd..
Recruitment status was: Recruiting
First Posted : October 2, 2018
Last Update Posted : October 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Triple Negative Breast Neoplasms||Biological: SCT200||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Recombinant Anti-EGFR Monoclonal Antibody（SCT200） in Patients With Relapsed or Metastatic Triple Receptor Negative Breast Cancer : a Phase Ⅱ, Open-label, Single-arm, Multicenter Study|
|Actual Study Start Date :||July 20, 2018|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Initially, 6.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 8.0mg/kg of SCT200 will be administered every two weeks until disease progression.
Recombinant Anti-EGFR Monoclonal Antibody（SCT200）
- Objective response rate (ORR) [ Time Frame: 1 year ]ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment.
- Adverse events (AEs) [ Time Frame: 1 year ]AE are assessed according to NCI CTCAE v4.03.
- Progress Free Survival ( PFS) [ Time Frame: 1 year ]PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 criteria.
- Duration of response (DOR) [ Time Frame: 1 year ]DOR is defined as time from the date when a patient first meets the criteria for CR or PR according to RECIST v1.1, until the date that progressive disease (PD) is objectively documented or death, whichever occurs first.
- Disease control rate (DCR) [ Time Frame: 1 year ]The achievement of any a stable response（SD）, partial response (PR) or complete response (CR), according to RECIST v1.1 criteria.
- Time to Progression (TTP) [ Time Frame: 1 year ]TTP is defined as the time from first dose of SCT200 until the date of first documentation of progressive disease (PD), according to RECIST v1.1 criteria.
- Overall survival (OS) [ Time Frame: 1 year ]OS is defined as time from first dose of SCT200 until the date of death from any cause.
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): NCT03692689
|Contact: qingyuan zhang, MDemail@example.com|
|Cancer Hospital Affiliated to Harbin Medical University||Recruiting|
|Harbin, Heilongjiang, China, 150081|
|Contact: qingyuan zhang, MD|
|Principal Investigator:||qingyuan zhang, MD||Cancer Hospital Affiliated to Harbin Medical University|