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PI3K Inhibitor

Alpelisib + Sacituzumab Govitecan for Breast Cancer (ASSET Trial)

Phase 1
Recruiting
Led By Priyanka Sharma, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients should have received at least one line of chemotherapy and at least one line of hormonal therapy (where appropriate) in either the advanced or neo/adjuvant setting. Patients who are candidates for anti-PD-1 and/or anti-PD-L1 therapy should have received at least one line of anti-PD-1 and/or anti-PD-L1 therapy in either the advanced or neo/adjuvant setting
Participants with previously treated brain metastases must be free of central nervous system symptoms and be >21 days from treatment of brain metastases. CNS brain metastasis should be clinically stable at the time of screening, and participant is not receiving steroids and/or enzyme inducing anti-epileptic medications for brain metastases
Must not have
Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
Patient has pneumonitis or interstitial lung disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of study treatment until removal from study treatment; estimated 24 months maximum.
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a combination of two drugs for patients with advanced HER2-negative breast cancer. One drug delivers chemotherapy directly to the cancer cells, and the other stops the cancer cells from growing.

Who is the study for?
This trial is for adults with HER2-negative breast cancer that's either locally advanced or has spread (metastatic). They should have tried at least one chemotherapy and, if applicable, hormonal therapy. Participants need to be able to take oral medication, not have uncontrolled diabetes, no recent major surgery or active severe infections, and can't be pregnant or breastfeeding. Those with certain heart conditions or a history of severe allergic reactions are also excluded.
What is being tested?
The study tests the combination of two drugs: Alpelisib and Sacituzumab Govitecan in treating metastatic or locally recurrent HER2-negative breast cancer. It aims to determine how safe this combination is and how effective it is in managing the disease.
What are the potential side effects?
Potential side effects may include digestive issues like nausea and diarrhea, blood sugar changes due to Alpelisib which targets specific proteins in cancer cells; as well as possible hair loss (alopecia), fatigue, lowered immune response from Sacituzumab Govitecan which delivers a toxic payload directly into cancer cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had chemotherapy, hormonal therapy, and anti-PD-1/PD-L1 therapy if suitable.
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My brain metastases are stable, I'm not on steroids or specific seizure meds, and it's been over 21 days since their treatment.
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I am 18 years old or older.
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I, or my legal representative, can understand the study and agree to sign the consent form.
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My breast cancer is HER2-negative, advanced, and cannot be cured with surgery.
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I finished my last chemotherapy for breast cancer more than 2 weeks ago and have mostly recovered from its side effects.
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My kidneys work well enough to clear at least 35 mL/min of creatinine.
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I am able to get out of my bed or chair and move around.
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My kidney function, measured by creatinine, is within normal limits.
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My cancer can be measured or seen on tests.
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I can swallow and keep down pills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a GI condition that could affect how I absorb medication.
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I have lung inflammation or scarring.
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I am on a medication that affects my heart's rhythm and cannot change it.
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I have inflammatory breast cancer.
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I have had pancreatitis within the last year or have chronic pancreatitis.
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I have a heart rhythm problem.
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I do not have an active Hepatitis B or C infection.
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I have a history of heart problems.
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My liver disease is moderately to severely advanced.
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I stopped taking BCRP inhibitors at least a week ago.
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I have untreated brain symptoms.
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I am currently taking warfarin or a similar blood thinner.
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I have type I diabetes or my type II diabetes is not under control.
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I have been treated with a PI3K or AKT inhibitor before.
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I have ongoing jawbone issues not yet healed.
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I am not using, nor do I plan to use, other cancer treatments or experimental drugs during this study.
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I have been treated with sacituzumab govitecan or alpelisib before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of study treatment until removal from study treatment; estimated 24 months maximum.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of study treatment until removal from study treatment; estimated 24 months maximum. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recommended phase II dose (RP2D) of alpelisib + sacituzumab govitecan
Secondary study objectives
Overall response rate (ORR) in patients with measurable disease
Pharmacokinetics of alpelisib when administered with sacituzumab govitecan
Pharmacokinetics of sacituzumab govitecan when administered with alpelisib

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Dose level 3: alpelisib 300 mg plus sacituzumab govitecan 10 mg/kgExperimental Treatment2 Interventions
Alpelisib: 300 mg by mouth daily Sacituzumab govitecan: 10 mg/kg intravenous on days 1 and 8 of each 21 (+/-2) day cycle
Group II: Dose level 2: alpelisib 250 mg plus sacituzumab govitecan 10 mg/kgExperimental Treatment2 Interventions
Alpelisib: 250 mg by mouth daily Sacituzumab govitecan: 10 mg/kg intravenous on days 1 and 8 of each 21 (+/-2) day cycle
Group III: Dose level 1: alpelisib 250 mg plus sacituzumab govitecan 8 mg/kgExperimental Treatment2 Interventions
Alpelisib: 250 mg by mouth daily Sacituzumab govitecan: 8 mg/kg intravenous on days 1 and 8 of each 21 (+/-2) day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alpelisib
2018
Completed Phase 3
~960
Sacituzumab govitecan
2017
Completed Phase 3
~530

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Sacituzumab Govitecan is an antibody-drug conjugate that targets Trop-2, delivering a cytotoxic agent directly to breast cancer cells, thereby minimizing damage to healthy cells. Alpelisib is a PI3K inhibitor that targets the PI3K pathway, which is often mutated in breast cancer, inhibiting cancer cell growth and survival. These targeted therapies are important for breast cancer patients as they offer more personalized treatment options, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.
First--select the target: better choice of adjuvant treatments for breast cancer patients.

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
513 Previous Clinical Trials
176,997 Total Patients Enrolled
22 Trials studying Breast Cancer
4,358 Patients Enrolled for Breast Cancer
Novartis PharmaceuticalsIndustry Sponsor
2,917 Previous Clinical Trials
4,254,166 Total Patients Enrolled
87 Trials studying Breast Cancer
37,738 Patients Enrolled for Breast Cancer
Gilead SciencesIndustry Sponsor
1,137 Previous Clinical Trials
868,004 Total Patients Enrolled
17 Trials studying Breast Cancer
6,229 Patients Enrolled for Breast Cancer

Media Library

Alpelisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05143229 — Phase 1
Breast Cancer Research Study Groups: Dose level 1: alpelisib 250 mg plus sacituzumab govitecan 8 mg/kg, Dose level 2: alpelisib 250 mg plus sacituzumab govitecan 10 mg/kg, Dose level 3: alpelisib 300 mg plus sacituzumab govitecan 10 mg/kg
Breast Cancer Clinical Trial 2023: Alpelisib Highlights & Side Effects. Trial Name: NCT05143229 — Phase 1
Alpelisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05143229 — Phase 1
~5 spots leftby Dec 2025