Trastuzumab and Pertuzumab in Combination With Tocilizumab in Subjects With Metastatic HER2 Positive Breast Cancer Resistant to Trastuzumab
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03135171|
Recruitment Status : Recruiting
First Posted : May 1, 2017
Last Update Posted : May 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Trastuzumab Drug: Pertuzumab Drug: Tocilizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Multi-Center Trial of Trastuzumab and Pertuzumab in Combination With Tocilizumab in Subjects With Metastatic HER2 Positive Breast Cancer Resistant to Trastuzumab|
|Actual Study Start Date :||May 22, 2017|
|Estimated Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||August 1, 2020|
|Experimental: Trastuzumab, Pertuzumab and Tocilizumab||
All dose levels will receive 8 mg/kg loading dose for cycle 1, followed by 6 mg/kg in subsequent cycles, every 3 weeks.
Dose Levels two and three will receive 840 mg loading dose for cycle 1, followed by 420 mg in subsequent cycles, every 3 weeks.
Tocilizumab 4-8 mg/kg, administered intravenously every three weeks
- Recommended Phase II Dose of Tocilizumab [ Time Frame: 10 weeks ]The primary objective is to determine the highest dose level of tocilizumab (up to 8 mg/kg every 3 weeks) that, when given in combination with trastuzumab and pertuzumab every three weeks in subjects with HER2 positive metastatic breast cancer, will result in less than 25% incidence of DLT. DLTs (Dose Limiting Toxicity) will be assessed within the first two cycles (up to 10 weeks) and defined as any toxicity of grade 3 or 4, unless specifically described in the protocol.
- The Frequency of Adverse Events at Each Dose Level [ Time Frame: 30 days after last treatment dose ]The number of grade 3 and 4 adverse events at each dose level will be described.
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): NCT03135171
|Contact: Monika Burness, M.D.||email@example.com|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Rita Nanda, MD|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Monika Burness, M.D. 800-865-1125 firstname.lastname@example.org|
|Principal Investigator: Monika Burness, M.D.|
|United States, New York|
|Yale University||Not yet recruiting|
|New Haven, New York, United States, 06520|
|Contact: Lajos Pusztai, MD, DPhil|
|Principal Investigator:||Monika Burness, M.D.||University of Michigan Rogel Cancer Center|