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Protein Kinase Inhibitor

Subtype-Targeted Therapeutics for Breast Cancer

Phase 2
Recruiting
Led By George Sledge
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pre-Screening Phase: Biopsy-proven ER-positive, HER2-negative breast cancer with ER-positivity and PR-positivity defined as ≥1% cells staining positive by immunohistochemistry. HER2-negativity defined by IHC or FISH, per ASCO-CAP 2018 guidelines. Breast tumor must be intact and tumor size must be ≥ 1 cm as measured by ultrasound, mammogram, MRI, or clinical exam. If tumor is locally recurrent, it must be in the breast (not skin, node, or chest wall recurrence). Ki67 may or may not have been done locally but if done locally, must be ≥ 5%. Any nodal status is allowed, as M0 or M1 disease. Women or men, age ≥ 18 years old. Performance status 0 to 1 (by Eastern Cooperative Oncology Group [ECOG] scale). Ability to understand and the willingness to sign a written informed consent document.
Treatment Phase: Breast tumor classifies as relevant integrative subtype per tumor sequencing performed and analyzed by central laboratory. Breast tumor Ki67 score ≥ 10% as assessed by central laboratory. Each investigational agent specific inclusion criteria can be found in the agent-specific appendix
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 or 19 days, based on the duration specified for the assigned therapy
Awards & highlights

Study Summary

This trial is testing whether a new drug, targeted at a specific genetic change found in some breast tumors, will slow the growth of the tumor more than standard anti-hormone therapy.

Who is the study for?
This trial is for adults with ER-positive, HER2-negative breast cancer that hasn't been treated yet. The tumor must be at least 1 cm and could be a new case or a local recurrence in the breast. Participants need to have certain gene changes in their tumors and meet specific health criteria.Check my eligibility
What is being tested?
The study tests if adding targeted drugs like Alpelisib, Tamoxifen, Zotatifin, or Fulvestrant before surgery can slow tumor growth better than standard hormone therapy alone. Each drug targets different genetic changes in the tumors.See study design
What are the potential side effects?
Potential side effects may include nausea, fatigue, skin rash, high blood sugar levels (especially with Alpelisib), hot flashes (common with Tamoxifen), liver enzyme changes (with Fulvestrant), and other reactions depending on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have breast cancer that is estrogen receptor-positive and HER2-negative, confirmed by a biopsy. The tumor must be at least 1 centimeter in size and located in the breast. You must be at least 18 years old and able to understand and sign a consent form.
Select...
My breast tumor is a specific type based on lab tests and has a growth rate of at least 10%.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 or 19 days, based on the duration specified for the assigned therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 or 19 days, based on the duration specified for the assigned therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage change in Ki67
Secondary outcome measures
Ki67 <10% on-treatment measurement

Trial Design

14Treatment groups
Experimental Treatment
Active Control
Group I: IC8:Zotatifin in combination with FulvestrantExperimental Treatment2 Interventions
Integrative subtype 8, Treatment (14 days, - 2 to +7 days). Zotatifin (calculated by weight, 0.10 mg/kg) should be administered as a 60-minute IV infusion on Days 1. A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.
Group II: IC7:Zotatifin in combination with FulvestrantExperimental Treatment2 Interventions
Integrative subtype 7, Treatment (14 days, - 2 to +7 days). Zotatifin (calculated by weight, 0.10 mg/kg) should be administered as a 60-minute IV infusion on Days 1. A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.
Group III: IC6:Zotatifin in combination with FulvestrantExperimental Treatment2 Interventions
Integrative subtype 6, Treatment (14 days, - 2 to +7 days). Zotatifin (calculated by weight, 0.10 mg/kg) should be administered as a 60-minute IV infusion on Days 1. A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.
Group IV: IC4:Zotatifin in combination with FulvestrantExperimental Treatment2 Interventions
Integrative subtype 4, Treatment (14 days, - 2 to +7 days). Zotatifin (calculated by weight, 0.10 mg/kg) should be administered as a 60-minute IV infusion on Days 1. A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.
Group V: IC3:Zotatifin in combination with FulvestrantExperimental Treatment2 Interventions
Integrative subtype 3, Treatment (14 days, - 2 to +7 days). Zotatifin (calculated by weight, 0.10 mg/kg) should be administered as a 60-minute IV infusion on Days 1. A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.
Group VI: IC2:Zotatifin in combination with FulvestrantExperimental Treatment2 Interventions
Integrative subtype 2, Treatment (14 days, - 2 to +7 days). Zotatifin (calculated by weight, 0.10 mg/kg) should be administered as a 60-minute IV infusion on Days 1. A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.
Group VII: IC1:Alpelisib in combination with TamoxifenExperimental Treatment2 Interventions
Integrative subtype IC1, Treatment (14 days, - 2 or + 7 days): Take assigned alpelisib pills, 300 mg (two 150 mg tablets) with food, once daily by mouth. Tamoxifen pills, 20 mg once daily by mouth
Group VIII: IC1:TamoxifenActive Control1 Intervention
Integrative subtype 1, Treatment (14 days, -2 to +7 days): Take assigned tamoxifen pills, 20 mg once daily by mouth
Group IX: IC2:FulvestrantActive Control1 Intervention
Integrative subtype 2, Treatment (14 days, - 2 to +7 days) A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.
Group X: IC3:FulvestrantActive Control1 Intervention
Integrative subtype 3, Treatment (14 days, - 2 to +7 days) A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1. on Day 1.
Group XI: IC4:FulvestrantActive Control1 Intervention
Integrative subtype 4, Treatment (14 days, - 2 to +7 days) A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1..
Group XII: IC6:FulvestrantActive Control1 Intervention
Integrative subtype 6, Treatment (14 days, - 2 to +7 days) A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.
Group XIII: IC7:FulvestrantActive Control1 Intervention
Integrative subtype 7, Treatment (14 days, - 2 to +7 days) A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.
Group XIV: IC8:FulvestrantActive Control1 Intervention
Integrative subtype 8, Treatment (14 days, - 2 to +7 days) A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alpelisib
2018
Completed Phase 3
~900
Tamoxifen
2005
Completed Phase 4
~30070
Zotatifin
2021
Completed Phase 1
~40
Fulvestrant
2011
Completed Phase 3
~3690

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,393 Previous Clinical Trials
17,341,407 Total Patients Enrolled
60 Trials studying Breast Cancer
111,030 Patients Enrolled for Breast Cancer
United States Department of DefenseFED
863 Previous Clinical Trials
227,482 Total Patients Enrolled
36 Trials studying Breast Cancer
3,316 Patients Enrolled for Breast Cancer
George SledgePrincipal InvestigatorStanford Universiy

Media Library

Alpelisib (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05101564 — Phase 2
Breast Cancer Research Study Groups: IC1:Alpelisib in combination with Tamoxifen, IC1:Tamoxifen, IC2:Zotatifin in combination with Fulvestrant, IC2:Fulvestrant, IC3:Zotatifin in combination with Fulvestrant, IC3:Fulvestrant, IC4:Zotatifin in combination with Fulvestrant, IC4:Fulvestrant, IC6:Zotatifin in combination with Fulvestrant, IC6:Fulvestrant, IC7:Zotatifin in combination with Fulvestrant, IC7:Fulvestrant, IC8:Zotatifin in combination with Fulvestrant, IC8:Fulvestrant
Breast Cancer Clinical Trial 2023: Alpelisib Highlights & Side Effects. Trial Name: NCT05101564 — Phase 2
Alpelisib (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05101564 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are enrolled in this clinical experiment?

"This trial is presently not recruiting, as the last amendment was made on November 16th 2022. However, if you are searching for other medical studies related to breast cancer there are currently 2601 active studies and 225 trials actively seeking participants in Infigratinib-related research."

Answered by AI

Is recruitment for this investigation still available for participants?

"At this current moment, no individuals can enroll in the study. This research was first posted on January 1st 2023 and received its last update a few weeks ago on November 16th 2022. If you are looking for an alternative trial, there are 2601 studies related to breast cancer that require patients and 225 trials involving Infigratinib recruiting participants."

Answered by AI

What diseases has Infigratinib been proven to help alleviate?

"Infigratinib is a viable solution for treating advance directives, polycystic ovary syndrome and breast cancer."

Answered by AI

What precautions must be taken when administering Infigratinib to patients?

"With prior data confirming a degree of safety, Infigratinib was given a score of 2 on our team's risk assessment scale. While there is some evidence suggesting its efficacy, this particular medical trial is still in the Phase 2 stage."

Answered by AI

Are there any prior experiments involving Infigratinib that have yielded noteworthy results?

"Currently, 225 Infigratinib trials are running globally. Of these investigations, 59 have progressed to the third phase of clinical research. The majority of studies for this drug are conducted in San Francisco yet there is a total of 13479 sites involved with its testing."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Umbrella Trial Testing Integrative Subtype-Targeted Therapeutics in HR+ /HER2-Negative Breast Cancer
2023. "Umbrella Trial Testing Integrative Subtype-Targeted Therapeutics in HR+ /HER2-Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05101564.
~83 spots leftby Sep 2025
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