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Breast CancerPhase 1ASSETNCT05143229

Alpelisib And Sacituzumab Govitecan For Treatment Of Breast Cancer

A Phase 1 study testing Alpelisib and Sacituzumab govitecan in people with Breast Cancer, run by University of Kansas Medical Center at 7 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study evaluates the safety and efficacy of sacituzumab govitecan plus alpelisib for treatment of metastatic or locally recurrent HER2-negative breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Alpelisib and Sacituzumab govitecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
7 sitesUnited States
Study dates
28 Mar 2022to Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
  • Males and females age ≥ 18 years
  • ECOG Performance Status 0 - 2 (See Appendix A)
  • Histologically proven HER2-negative breast cancer (per current ASCO-CAP guidelines); HER2-negative breast cancer includes hormone receptor-positive (estrogen receptor and/or progesterone receptor-positive) breast cancer and TNBC.
  • HER2-negative breast cancer that at the time of study entry is either stage III (locally advanced) disease not amenable to curative therapy, or stage IV disease. Histological confirmation of recurrent/metastatic disease is encouraged but not required if clinical evidence of stage IV disease is available.
  • Have measurable or evaluable disease.
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  • Ability to swallow and retain oral medicines.
  • No limitations to number of prior chemotherapies or endocrine therapies for metastatic disease.
  • 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.
  • Prior palliative radiation therapy to bony metastases is allowed. A minimum of 14 days between the end of radiation treatment and start of study treatment is required.
  • 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.
  • Participants must be >2 weeks or 5 half-lives (whichever is longer) from prior systemic chemotherapy for breast cancer AND should have recovered to Grade 1 or better (except alopecia and neuropathy) from related side effects of any prior antineoplastic therapy prior to study entry.
  • Women of childbearing potential must have a negative serum pregnancy test 24 hours prior to initiating treatment.
  • Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use approved forms of contraception for the duration of study participation and for 6 months following completion of therapy.
  • Fasting plasma glucose ≤140 mg/dL or ≤7.8 mmol/L
  • HbA1c ≤6.4%
  • Absolute neutrophil count ≥ 1500/uL NOTE: Patients with established diagnosis of benign neutropenia are eligible to participate with ANC between 1000-1500 if in the opinion of treating physician the trial treatment does not pose excessive risk of infection to the patient.
  • Platelets ≥ 100,000/uL (no transfusion allowed within 2 weeks)
  • Hemoglobin > 9 g/dL (which may be reached by transfusion)
  • Total bilirubin within normal range or ≤ 1.5x institutional upper limit of normal (IULN) if liver metastases are present, or total bilirubin ≤ 3.0x IULN with direct bilirubin within normal range in patients with well-documented Gilbert's Syndrome, which is defined as presence of unconjugated hyperbilirubinemia with normal results from CBC (including normal reticulocyte count and blood smear), normal liver function test results and absence of other contributing disease processes at the time of diagnosis.
  • AST(SGOT)/ALT(SPGT) ≤ 2.5x IULN or ≤ 5x IULN if liver metastases are present
  • Serum creatinine ≤ 1.5x IULN
  • Creatinine clearance ≥ 35 mL/min using Cockcroft-Gault formula
  • Potassium within institutional normal limits
  • Magnesium within institutional normal limits
  • Calcium (corrected for serum albumin) within institutional normal limits or ≤grade 1 according to NCI-CTCAE version 4.03 if judged clinically not significant by the investigator
  • Serum amylase ≤ 2x IULN
  • Serum lipase within institutional normal limits
  • Albumin ≥ 2.5 g/dL

Who cannot join

  • Simultaneously enrolled in any therapeutic clinical trial
  • Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
  • Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
  • Is pregnant or breastfeeding
  • Has a known allergic reaction to any excipient contained in the study drug formulation Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment.
  • Patient has previously been treated with sacituzumab govitecan or alpelisib.
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  • Patient has a concurrent malignancy or malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer, or curatively resected cervical cancer).
  • Diabetes mellitus type I, or uncontrolled type II based on fasting plasma glucose and HbA1c meeting either of the following:
  • Fasting plasma glucose >140 mg/dL or >7.8 mmol/L
  • HbA1c ≥6.5% Note: For patients with fasting plasma glucose ≥ 100 mg/dL and/or HbA1c ≥5.7% (i.e. threshold for pre-diabetes) at baseline, lifestyle changes according to American Diabetes Association guidelines were recommended
  • 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 is classified into Child-Pugh class B or C.
  • Patient has a known history of HIV infection (testing not mandatory).
  • Patient has active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV). In patients with a history of HBV or HCV, patients with a detectable viral load will be excluded.
  • Patient has symptomatic/untreated CNS disease.
  • Patient has active cardiac disease or a history of cardiac dysfunction including any of the following:
  • Uncontrolled hypertension defined by a systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mm Hg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening.
  • Unstable angina pectoris within 6 months prior to study entry
  • Symptomatic pericarditis
  • Documented myocardial infarction within 6 months prior to study entry
  • Coronary artery bypass graft within 6 months prior to study entry
  • History of documented congestive heart failure (New York Heart Association functional classification III-IV)
  • Documented cardiomyopathy
  • Patient has a left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)
  • Patient has any of the following cardiac conduction abnormalities:
  • Ventricular arrhythmias, except for benign premature ventricular contractions
  • Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medicine
  • Conduction abnormality requiring a pacemaker
  • Other cardiac arrhythmia not controlled with medication
  • Patient has a QTcF > 470 msec if female and >450 msec if male on the screening ECG (using the QTcF formula).
  • Patient is currently receiving treatment with a medication that has a known risk to prolong the QT interval or induce Torsades de Pointes and the treatment cannot be discontinued or switched to a different medication prior to start of study drug.
  • Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
  • Participant has received palliative radiation therapy ≤ 2 weeks prior to starting study drug, or has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia).
  • Patient is currently receiving or has received high-dose systemic corticosteroids (≥20mg of prednisone or its equivalent) ≤ 2 weeks prior to starting study drug or has not fully recovered from side effects of such treatment.
  • Note: The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular).
  • Patient is currently receiving treatment with drugs known to be moderate or strong inhibitors or inducers of isoenzyme CYP3A. The patient must have discontinued strong inducers for at least one week before the start of treatment.
  • Patient is currently receiving treatment with inhibitor(s) of BCRP (see Appendix B, table with heading Prohibited BRCP inhibitors). The patient must have discontinued BCRP inhibitors for at least one week before the start of treatment.
  • Patient is currently receiving warfarin or other coumarin-derived anti-coagulant for treatment, prophylaxis or otherwise.
  • Patient has received previous treatment with a PI3K inhibitor or AKT inhibitor
  • Patient has a history of acute (within one year of study entry) pancreatitis or past medical history of chronic pancreatitis.
  • Patient has pneumonitis or interstitial lung disease.
  • Patient has unresolved osteonecrosis of the jaw.
  • Patient has inflammatory breast cancer.
  • Patient has a history of severe cutaneous reactions, such as Steven-Johnson Syndrome (SJS), erythema multiforme (EM), toxic epidermal necrolysis (TEM), or drug reaction with eosinophilia and systemic syndrome (DRESS).
  • Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation in the clinical study (including, but not limited to: severe immune disease, certain degenerative diseases, certain other acute or chronic concurrent illnesses).

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • The University of Kansas Clinical Research Center

    Fairway, Kansas, 66205

  • The University of Kansas Cancer Center - North Kansas City Hospital

    Kansas City, Missouri, 64116

  • The University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • The University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

  • The University of Kansas Cancer Center - Overland Park

    Overland Park, Kansas, 66210

  • The University of Kansas Cancer Center - Indian Creek

    Overland Park, Kansas, 66211

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: Phase I Trial Of Alpelisib Plus Sacituzumab Govitecan In Patients With Metastatic Or Locally Recurrent HER2-Negative Breast Cancer

This study evaluates the safety and efficacy of sacituzumab govitecan plus alpelisib for treatment of metastatic or locally recurrent HER2-negative breast cancer.

Conditions
Breast Cancer
Being tested
Alpelisib, Sacituzumab govitecan
Keywords
HER2-negative, Metastatic/locally advanced, Sacituzumab govitecan, Alpelisib, RP2D, Trop-2 antibody-drug conjugate, PI3K inhibitor
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlpelisibDrug

    Also called Piqray

    PI3K inhibitor

  • Sacituzumab govitecanDrug

    Also called Trodelvy

    Trop-2-directed antibody and topoisomerase inhibitor drug conjugate

Study groups in NCT05143229
Study groupRoleWhat they receive
Dose level 1: alpelisib 250 mg plus sacituzumab govitecan 8 mg/kgExperimentalAlpelisib: 250 mg by mouth daily Sacituzumab govitecan: 8 mg/kg intravenous on days 1 and 8 of each 21 (+/-2) day cycle
Receives: Drug: Alpelisib; Drug: Sacituzumab govitecan
Dose level 2: alpelisib 250 mg plus sacituzumab govitecan 10 mg/kgExperimentalAlpelisib: 250 mg by mouth daily Sacituzumab govitecan: 10 mg/kg intravenous on days 1 and 8 of each 21 (+/-2) day cycle
Receives: Drug: Alpelisib; Drug: Sacituzumab govitecan
Dose level 3: alpelisib 300 mg plus sacituzumab govitecan 10 mg/kgExperimentalAlpelisib: 300 mg by mouth daily Sacituzumab govitecan: 10 mg/kg intravenous on days 1 and 8 of each 21 (+/-2) day cycle
Receives: Drug: Alpelisib; Drug: Sacituzumab govitecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended phase II dose (RP2D) of alpelisib + sacituzumab govitecan

    Standard 3+3 dose escalation design (three dose levels of alpelisib plus sacituzumab govitecan) with dose-limiting toxicities (DLT) assessed during the first treatment cycle. If two or more of the six patients experienced a dose-limiting toxicity, dosing escalation would cease and maximum tolerated dose (MTD) would be reached. RP2D was the next lower dose at which <1/6 subjects experienced a DLT.

    Measured: 21 days

Secondary outcomes (3)

  1. Pharmacokinetics of alpelisib when administered with sacituzumab govitecan

    Alpelisib area under the curve (AUC): blood sampling pre-dose and 0.5, 1, 2, 3, 4, 6, 24, and 48 hours post-sacituzumab govitecan dose

    Measured: In cycle 1, from prior to sacituzumab govitecan dosing through 48 hours after sacituzumab govitecan dosing

  2. Pharmacokinetics of sacituzumab govitecan when administered with alpelisib

    Sacituzumab govitecan, free SN-38, and total SN-38 area under the curve (AUC): blood sampling pre-dose and 0.5, 1, 2, 3, 4, 6, 24, and 48 hours post-sacituzumab govitecan dose

    Measured: In cycle 1, from prior to sacituzumab govitecan dosing through 48 hours after sacituzumab govitecan dosing

  3. Overall response rate (ORR) in patients with measurable disease

    ORR includes complete response (CR) plus partial response (PR). As evaluated per RECIST version 1.1.

    Measured: From start of study treatment until removal from study treatment; estimated 24 months maximum.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2021
  2. Study start28 Mar 2022
  3. Primary completion28 Jan 2025
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Standard 3+3 dose escalation
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05143229
Sponsor's protocol ID
IIT-2021-ASSET
Acronym
ASSET
Status last verified
Apr 2026
First submitted
19 Nov 2021
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Alpelisib and Sacituzumab govitecan in people with Breast Cancer, run by University of Kansas Medical Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended phase II dose (RP2D) of alpelisib + sacituzumab govitecan (time frame: 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05143229.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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