University of Kansas Medical Center
Priyanka Sharma
This study evaluates the safety and efficacy of sacituzumab govitecan plus alpelisib for treatment of metastatic or locally recurrent HER2-negative breast cancer.
Breast Cancer
Alpelisib
Sacituzumab govitecan
Phase 1
Study Type : | Interventional |
Estimated Enrollment : | 18 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | Phase I Trial Of Alpelisib Plus Sacituzumab Govitecan In Patients With Metastatic Or Locally Recurrent HER2-Negative Breast Cancer |
Actual Study Start Date : | March 28, 2022 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Dose level 1: alpelisib 250 mg plus sacituzumab govitecan 8 mg/kg Alpelisib: 250 mg by mouth daily Sacituzumab govitecan: 8 mg/kg intravenous on days 1 and 8 of each 21 (+/-2) day cycle |
Drug: Alpelisib Drug: Sacituzumab govitecan |
Experimental: Dose level 2: alpelisib 250 mg plus sacituzumab govitecan 10 mg/kg Alpelisib: 250 mg by mouth daily Sacituzumab govitecan: 10 mg/kg intravenous on days 1 and 8 of each 21 (+/-2) day cycle |
Drug: Alpelisib Drug: Sacituzumab govitecan |
Experimental: Dose level 3: alpelisib 300 mg plus sacituzumab govitecan 10 mg/kg Alpelisib: 300 mg by mouth daily Sacituzumab govitecan: 10 mg/kg intravenous on days 1 and 8 of each 21 (+/-2) day cycle |
Drug: Alpelisib Drug: Sacituzumab govitecan |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
The University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
Recruiting
The University of Kansas Cancer Center - Overland Park
Overland Park, Kansas, United States, 66210
Recruiting
The University of Kansas Cancer Center - Indian Creek
Overland Park, Kansas, United States, 66211
Recruiting
The University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Recruiting
The University of Kansas Cancer Center - North Kansas City Hospital
Kansas City, missouri, United States, 64116
Recruiting
The University of Kansas Cancer Center - North
Kansas City, missouri, United States, 64154
Recruiting
The University of Kansas Cancer Center - Lee's Summit
Lee's Summit, missouri, United States, 64064