Alpelisib And Sacituzumab Govitecan For Treatment Of Breast Cancer

Running, not enrolling · Phase 1

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT05143229

Run by

University of Kansas Medical Center

People needed

18

Starts

2022-03-28

Expected to finish

2026-12-01

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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

You may not qualify if…

• 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.
• 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:

Where it is running

• The University of Kansas Clinical Research Center — Fairway, Kansas, United States
• The University of Kansas Cancer Center - Overland Park — Overland Park, Kansas, United States
• The University of Kansas Cancer Center - Indian Creek — Overland Park, Kansas, United States
• The University of Kansas Cancer Center — Westwood, Kansas, United States
• The University of Kansas Cancer Center - North Kansas City Hospital — Kansas City, Missouri, United States
• The University of Kansas Cancer Center - North — Kansas City, Missouri, United States
• The University of Kansas Cancer Center - Lee's Summit — Lee's Summit, Missouri, United States

Full record on ClinicalTrials.gov

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