~4 spots leftby Apr 2026

Alpelisib + Sacituzumab Govitecan for Breast Cancer

(ASSET Trial)

Recruiting in Palo Alto (17 mi)
+6 other locations
Priyanka Sharma
Overseen byPriyanka Sharma, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: University of Kansas Medical Center
Must not be taking: CYP3A inhibitors, BCRP inhibitors, Warfarin
Disqualifiers: Pregnancy, Diabetes, Cardiac disease, others
No Placebo Group
Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial requires that you stop taking certain medications before starting the study. Specifically, you must discontinue strong inducers of CYP3A and BCRP inhibitors at least one week before the trial. If you are on medications that prolong the QT interval or are taking warfarin, you may need to stop or switch them as well.

What data supports the effectiveness of the drug Alpelisib in combination with Sacituzumab Govitecan for breast cancer?

Alpelisib has shown effectiveness in treating hormone receptor-positive, HER2-negative breast cancer with PIK3CA mutations, as demonstrated in the SOLAR-1 trial. Sacituzumab Govitecan, although not directly mentioned in the provided research, is known for its use in treating certain types of breast cancer, suggesting potential effectiveness when combined with Alpelisib.12345

What safety data exists for Sacituzumab Govitecan in humans?

Sacituzumab Govitecan has been studied in patients with advanced solid tumors, including breast cancer, and common side effects include nausea, neutropenia (low white blood cell count), diarrhea, fatigue, anemia (low red blood cell count), vomiting, hair loss, constipation, rash, decreased appetite, and abdominal pain. These side effects were observed in more than 25% of patients in clinical trials.678910

What makes the drug Alpelisib + Sacituzumab Govitecan unique for breast cancer treatment?

This drug combination is unique because it includes Sacituzumab Govitecan, an antibody-drug conjugate that targets Trop-2, a protein often found on cancer cells, and delivers a chemotherapy agent directly to the tumor, potentially increasing effectiveness and reducing side effects compared to standard chemotherapy.6891011

Research Team

Priyanka Sharma

Priyanka Sharma, MD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

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.

Inclusion Criteria

My calcium levels are normal or slightly above but not concerning.
My brain metastases are stable, I'm not on steroids or specific seizure meds, and it's been over 21 days since their treatment.
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.
See 26 more

Exclusion Criteria

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.
I have lung inflammation or scarring.
See 26 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive alpelisib and sacituzumab govitecan in a 21-day cycle with dose escalation to determine the recommended phase II dose

21 days per cycle
Intravenous administration on days 1 and 8 of each cycle

Pharmacokinetics Assessment

Blood sampling for pharmacokinetics of alpelisib and sacituzumab govitecan

48 hours post-dose in cycle 1
Multiple blood sampling visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

Estimated 24 months maximum

Treatment Details

Interventions

  • Alpelisib (PI3K Inhibitor)
  • Sacituzumab govitecan (Monoclonal Antibodies)
Trial OverviewThe 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.
Participant Groups
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

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
The University of Kansas Clinical Research CenterFairway, KS
The University of Kansas Cancer Center - Overland ParkOverland Park, KS
The University of Kansas Cancer Center - Indian CreekOverland Park, KS
The University of Kansas Cancer CenterWestwood, KS
More Trial Locations
Loading ...

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials
527
Patients Recruited
181,000+

Novartis Pharmaceuticals

Industry Sponsor

Trials
2963
Patients Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali

Gilead Sciences

Industry Sponsor

Trials
1150
Patients Recruited
878,000+

Findings from Research

Alpelisib (Piqray) is effective for treating advanced or metastatic breast cancer that is HR-positive, HER2-negative, and has PIK3CA mutations, targeting specific genetic alterations to improve treatment outcomes.
Polatuzumab vedotin-piiq (Polivy) is used for diffuse large B-cell lymphoma, while eculizumab (Soliris) is indicated for neuromyelitis optica spectrum disorder, highlighting the development of targeted therapies for specific cancer types and autoimmune conditions.
Pharmaceutical Approval Update.Choy, M.[2020]
Alpelisib (PIQRAY®) is the first PI3K inhibitor approved for treating hormone receptor-positive metastatic breast cancer with PIK3CA mutations, showing promising clinical results that support its use in overcoming endocrine resistance.
The review highlights the pharmacodynamic and pharmacokinetic properties of alpelisib, along with safety and efficacy data from the Phase III SOLAR-1 trial, which led to its FDA approval, indicating its potential as a tailored treatment option.
Alpelisib in the treatment of metastatic HR+ breast cancer with PIK3CA mutations.Mavratzas, A., Marmé, F.[2021]
Alpelisib (Piqray™) is an oral PI3K inhibitor specifically targeting PI3Kα, showing efficacy in treating hormone receptor-positive, HER2-negative breast cancer in patients with a PIK3CA mutation.
The drug has been approved in the USA for use in combination with fulvestrant, marking a significant milestone in its development for breast cancer treatment.
Alpelisib: First Global Approval.Markham, A.[2020]

References

Pharmaceutical Approval Update. [2020]
Alpelisib in the treatment of metastatic HR+ breast cancer with PIK3CA mutations. [2021]
Alpelisib: First Global Approval. [2020]
A Phase Ib Study of Alpelisib or Buparlisib Combined with Tamoxifen Plus Goserelin in Premenopausal Women with HR-Positive HER2-Negative Advanced Breast Cancer. [2021]
A Cohort Study of the Antitumor Efficacy and Toxicity Profile of Alpelisib for Metastatic or Locally Advanced HR+, HER2- Breast Cancer: A Single-Institution Experience. [2023]
Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. [2021]
FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer. [2022]
The European Medicines Agency review of sacituzumab govitecan for the treatment of triple-negative breast cancer. [2022]
Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. [2019]
Safety and effectiveness of sacituzumab govitecan in patients with metastatic triple-negative breast cancer in real-world settings: first observations from an interdisciplinary breast cancer centre in Germany. [2023]
Sacituzumab Govitecan: First Approval. [2021]