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Protein Kinase Inhibitor

Subtype-Targeted Therapeutics for Breast Cancer

Phase 2
Waitlist Available
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
Must not have
Known hypersensitivity to study agent (IP) or standard endocrine therapy drug, or to any of the excipients of study agent (IP) or standard endocrine therapy drug. Each study agent specific exclusion 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
No Placebo-Only Group

Summary

This trial is testing a new drug that targets specific genetic changes found in some breast cancers. It aims to slow down tumor growth more effectively than standard treatments. The study focuses on patients with certain types of breast cancer that have these genetic features.

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.
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.
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%.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am allergic to the medication or its ingredients used in this study.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 Tamoxifen (closed to enrollment)Experimental 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:Tamoxifen (closed to enrollment)Active 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
~960
Tamoxifen
2005
Completed Phase 4
~30110
Zotatifin
2021
Completed Phase 1
~40
Fulvestrant
2011
Completed Phase 3
~3890

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
Common treatments for breast cancer, particularly targeted therapies, work by interfering with specific molecular pathways activated by genetic changes in cancer cells. For example, hormone receptor-positive therapies block estrogen or progesterone receptors, HER2-targeted therapies inhibit the HER2 protein, and PI3K/AKT/mTOR inhibitors disrupt signaling pathways crucial for cancer cell growth. These targeted approaches are important for breast cancer patients as they enable personalized treatment plans, potentially increasing efficacy and reducing side effects compared to traditional chemotherapy.
Therapeutic approaches for relapsed/refractory adult acute lymphoblastic leukemia (ALL), a review on monoclonal antibodies and targeted therapies.Intervention in the context of development: pathways toward new treatments.Pharmacokinetics, clinical indications, and resistance mechanisms in molecular targeted therapies in cancer.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,462 Previous Clinical Trials
17,494,921 Total Patients Enrolled
60 Trials studying Breast Cancer
111,030 Patients Enrolled for Breast Cancer
United States Department of DefenseFED
904 Previous Clinical Trials
333,210 Total Patients Enrolled
37 Trials studying Breast Cancer
103,325 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 (closed to enrollment), IC1:Tamoxifen (closed to enrollment), 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
~7 spots leftby Sep 2025