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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of study treatment until removal from study treatment; estimated 24 months maximum.
Awards & highlights
ASSET Trial Summary
This trial found that combining sacituzumab govitecan with alpelisib may help treat HER2-negative breast cancer that has spread or returned.
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.Check my eligibility
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.See study design
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.
ASSET Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
ASSET Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of study treatment until removal from study treatment; estimated 24 months maximum.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of study treatment until removal from study treatment; estimated 24 months maximum.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended phase II dose (RP2D) of alpelisib + sacituzumab govitecan
Secondary outcome measures
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
ASSET 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
~900
Sacituzumab govitecan
2017
Completed Phase 3
~530
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
463 Previous Clinical Trials
169,252 Total Patients Enrolled
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4,492 Patients Enrolled for Breast Cancer
Novartis PharmaceuticalsIndustry Sponsor
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4,198,291 Total Patients Enrolled
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37,800 Patients Enrolled for Breast Cancer
Gilead SciencesIndustry Sponsor
1,084 Previous Clinical Trials
848,244 Total Patients Enrolled
16 Trials studying Breast Cancer
6,436 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My calcium levels are normal or slightly above but not concerning.I have a GI condition that could affect how I absorb medication.I had palliative radiation therapy less than 2 weeks ago or still have side effects from it.My brain metastases are stable, I'm not on steroids or specific seizure meds, and it's been over 21 days since their treatment.I have lung inflammation or scarring.I am on a medication that affects my heart's rhythm and cannot change it.Your absolute neutrophil count (a type of white blood cell) is at least 1500 per microliter. If you have a condition causing low neutrophil count, you may still be eligible if your count is between 1000-1500 and your doctor thinks the trial treatment won't increase your risk of infection too much.I have inflammatory breast cancer.Women who could become pregnant must have a negative pregnancy test within 24 hours before starting treatment.Your potassium levels are within the normal range at the hospital where you're being treated.I haven't had cancer, except for certain skin or cervical cancers, in the last 3 years.Your HbA1c level is less than or equal to 6.4%.I have had pancreatitis within the last year or have chronic pancreatitis.I've had chemotherapy, hormonal therapy, and anti-PD-1/PD-L1 therapy if suitable.I have a heart rhythm problem.My bilirubin levels are within the normal range or slightly higher if I have liver metastases.Your magnesium levels are within the normal range at the hospital.I do not have an active Hepatitis B or C infection.I have a history of heart problems.I am 18 years old or older.My liver disease is moderately to severely advanced.I stopped taking BCRP inhibitors at least a week ago.I, or my legal representative, can understand the study and agree to sign the consent form.My breast cancer is HER2-negative, advanced, and cannot be cured with surgery.I finished my last chemotherapy for breast cancer more than 2 weeks ago and have mostly recovered from its side effects.My hemoglobin level is above 9 g/dL, possibly after a transfusion.My kidneys work well enough to clear at least 35 mL/min of creatinine.I have untreated brain symptoms.I am currently taking warfarin or a similar blood thinner.Your blood sugar levels when you have not eaten should be less than 140 mg/dL or 7.8 mmol/L.I am able to get out of my bed or chair and move around.I had radiation for bone metastases and it's been over 2 weeks since my last treatment.I have type I diabetes or my type II diabetes is not under control.Your blood amylase levels are not more than twice the normal limit.You have been diagnosed with HIV in the past. Testing for HIV is not required to participate.Your albumin level in your blood is at least 2.5 grams per deciliter.I have been treated with a PI3K or AKT inhibitor before.My kidney function, measured by creatinine, is within normal limits.I am not currently on strong drugs that affect liver enzymes.I have ongoing jawbone issues not yet healed.My cancer can be measured or seen on tests.I can swallow and keep down pills.I haven't had major surgery in the last 2 weeks or still have major side effects from it.I am not allergic to the study drug and have not had a severe infection in the last 2 weeks.I've taken high-dose steroids recently or am still experiencing their side effects.I am not using, nor do I plan to use, other cancer treatments or experimental drugs during this study.I have had multiple treatments for my cancer that has spread.You have had serious skin reactions like Steven-Johnson Syndrome, erythema multiforme, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic syndrome in the past.I have been treated with sacituzumab govitecan or alpelisib before.My breast cancer is HER2-negative, possibly hormone receptor-positive or triple-negative.Your liver enzyme levels are not too high, unless you have cancer that has spread to your liver.My platelet count is at least 100,000/uL without recent transfusions.Your blood test for lipase is within the normal range for the hospital where you are being treated.
Research Study Groups:
This trial has the following groups:- Group 1: Dose level 1: alpelisib 250 mg plus sacituzumab govitecan 8 mg/kg
- Group 2: Dose level 2: alpelisib 250 mg plus sacituzumab govitecan 10 mg/kg
- Group 3: Dose level 3: alpelisib 300 mg plus sacituzumab govitecan 10 mg/kg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Sacituzumab govitecan a secure option for those in need of treatment?
"With limited clinical evidence to support safety and efficacy, Sacituzumab govitecan was rated a 1 on the risk spectrum."
Answered by AI
What is the current sample size of this research endeavor?
"Affirmative. The clinicaltrial.gov website reveals that this experiment, initiated on March 28th 2022, is presently recruiting individuals. Around 18 volunteers are required from 7 distinct sites."
Answered by AI
What medical maladies is Sacituzumab govitecan usually prescribed to address?
"Sacituzumab govitecan is used to facilitate therapeutic processes, as well as to medicate certain conditions such as pharmacotherapy, uc 84572, and breast cancer."
Answered by AI
How many medical institutions are conducting this experiment?
"Currently, this trial is occurring in 7 different sites. Specifically, Kansas City, Lee's Summit and Westwood have clinical locations; other centres are also available for recruitment. To reduce travel burdens for those participating in the study it may be wise to choose a clinic nearest you."
Answered by AI
Has Sacituzumab govitecan been tested in any prior scientific experiments?
"Presently, 64 Sacituzumab govitecan related studies are actively being conducted with 12 in the third phase. While many of these trials are New york-based, over two thousand six hundred and ninety five sites worldwide have research projects revolving around Sacituzumab govitecan."
Answered by AI
Is there still an opportunity for potential subjects to join this investigation?
"Per current information on clinicaltrials.gov, this medical test is actively recruiting volunteers to participate. It was first announced on March 28th 2022 and underwent its most recent update April 4th 2022."
Answered by AI
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