Study Summary
This trial found that combining sacituzumab govitecan with alpelisib may help treat HER2-negative breast cancer that has spread or returned.
Eligible Conditions
- Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: From start of study treatment until removal from study treatment; estimated 24 months maximum.
21 days
Recommended phase II dose (RP2D) of alpelisib + sacituzumab govitecan
Month 24
Overall response rate (ORR) in patients with measurable disease
Hour 48
Pharmacokinetics of alpelisib when administered with sacituzumab govitecan
Pharmacokinetics of sacituzumab govitecan when administered with alpelisib
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Dose level 1: alpelisib 250 mg plus sacituzumab govitecan 8 mg/kg
1 of 3
Dose level 2: alpelisib 250 mg plus sacituzumab govitecan 10 mg/kg
1 of 3
Dose level 3: alpelisib 300 mg plus sacituzumab govitecan 10 mg/kg
1 of 3
Experimental Treatment
18 Total Participants · 3 Treatment Groups
Primary Treatment: Sacituzumab govitecan · No Placebo Group · Phase 1
Dose level 1: alpelisib 250 mg plus sacituzumab govitecan 8 mg/kgExperimental Group · 2 Interventions: Sacituzumab govitecan, Alpelisib · Intervention Types: Drug, Drug
Dose level 2: alpelisib 250 mg plus sacituzumab govitecan 10 mg/kgExperimental Group · 2 Interventions: Sacituzumab govitecan, Alpelisib · Intervention Types: Drug, Drug
Dose level 3: alpelisib 300 mg plus sacituzumab govitecan 10 mg/kgExperimental Group · 2 Interventions: Sacituzumab govitecan, Alpelisib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacituzumab govitecan
FDA approved
Alpelisib
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from start of study treatment until removal from study treatment; estimated 24 months maximum.
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
401 Previous Clinical Trials
158,351 Total Patients Enrolled
21 Trials studying Breast Cancer
3,990 Patients Enrolled for Breast Cancer
Gilead SciencesIndustry Sponsor
1,016 Previous Clinical Trials
659,929 Total Patients Enrolled
10 Trials studying Breast Cancer
3,146 Patients Enrolled for Breast Cancer
Novartis PharmaceuticalsIndustry Sponsor
2,718 Previous Clinical Trials
3,525,369 Total Patients Enrolled
80 Trials studying Breast Cancer
30,381 Patients Enrolled for Breast Cancer
Priyanka Sharma, MDPrincipal InvestigatorUniversity of Kansas Medical Center
7 Previous Clinical Trials
1,849 Total Patients Enrolled
4 Trials studying Breast Cancer
1,594 Patients Enrolled for Breast Cancer
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:This study is for women with HER2-negative breast cancer that is either at stage III (locally advanced) and not curable, or stage IV and has spread to other parts of the body
A person with an ECOG performance status of 0 or 1 is considered to have a good performance status
Breast cancer that is not positive for the HER2 protein, as determined by current guidelines from the American Society of Clinical Oncology and the College of American Pathologists, including tumors that are positive for the estrogen receptor and/or the progesterone receptor.
Patients who have received at least one line of chemotherapy and one line of hormonal therapy in either the advanced or neo/adjuvant setting are candidates for anti-PD-1 and/or anti-PD-L1 therapy.
The study participant OR their legal representative must be able to understand the study, and be willing to sign a written informed consent.
People over the age of 18 who are male or female.
There are no limitations to the number of prior chemotherapies or endocrine therapies a patient may have received for metastatic disease.
Be afflicted with a disease that can be measured or evaluated.
The ability to swallow and retain oral medicines.
Subjects who have received prior radiation therapy to their bony metastases are allowed to participate in this study
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Conditions
Cancer Related
Treatments