What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as Sacituzumab Govitecan and Alpelisib, have specific side effects. Sacituzumab Govitecan often leads to neutropenia, diarrhea, nausea, fatigue, and alopecia. Alpelisib is associated with hyperglycemia, rash, diarrhea, and decreased appetite. These side effects are important considerations when evaluating treatment options.

What prior FDA approvals exist?

Sacituzumab Govitecan, an antibody-drug conjugate targeting Trop-2, has been approved by the FDA for the treatment of metastatic triple-negative breast cancer. Alpelisib, a PI3K inhibitor, is approved for use with fulvestrant in hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer. These approvals highlight the FDA's recognition of targeted therapies in managing specific subtypes of breast cancer, focusing on molecular and genetic profiles to improve treatment efficacy.

What other types of research exist?

Promising novel alternatives for breast cancer treatment in 2024 include: 1) Trastuzumab Deruxtecan (Enhertu), an antibody-drug conjugate targeting HER2, which has shown efficacy in HER2-low breast cancer. 2) Tucatinib (Tukysa), a HER2-targeted tyrosine kinase inhibitor, often used in combination with trastuzumab and capecitabine. 3) Pembrolizumab (Keytruda), an immune checkpoint inhibitor targeting PD-1, which has shown promise in combination with chemotherapy for triple-negative breast cancer. 4) Elacestrant, an oral selective estrogen receptor degrader (SERD), for ER-positive, HER2-negative advanced breast cancer. These treatments represent significant advancements and offer new hope for breast cancer patients.

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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 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.

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

0 / 28Eligibility criteria met

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.