What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as PI3K/mTOR inhibitors (e.g., Gedatolisib), estrogen receptor antagonists (e.g., Fulvestrant), and CDK4/6 inhibitors (e.g., Palbociclib), have distinct side effect profiles. PI3K/mTOR inhibitors often cause hyperglycemia, diarrhea, and stomatitis. Estrogen receptor antagonists like Fulvestrant can lead to injection site reactions, hot flashes, and fatigue. CDK4/6 inhibitors, such as Palbociclib, are associated with neutropenia, fatigue, and nausea. These side effects are generally manageable but require careful monitoring and supportive care.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of breast cancer that target similar pathways to those being studied in the trial with Gedatolisib, Fulvestrant, and Palbociclib. Alpelisib, a PI3K inhibitor, is approved for use with Fulvestrant in hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer. Everolimus, an mTOR inhibitor, is also approved for use with Exemestane in postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer. Fulvestrant, an estrogen receptor antagonist, is widely used in various combinations for hormone receptor-positive breast cancer. Palbociclib, a CDK4/6 inhibitor, is approved for use with endocrine therapy such as Letrozole or Fulvestrant in hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.

What other types of research exist?

Promising novel alternatives for HR+/HER2- breast cancer treatment in 2024 include: 1) Abemaciclib plus Trastuzumab with or without Fulvestrant, which targets CDK4/6 and HER2 pathways; 2) Buparlisib (pan-PI3K inhibitor) in combination with Fulvestrant, which targets the PI3K pathway; and 3) Alpelisib (PI3Kα inhibitor) combined with Fulvestrant, specifically targeting PI3Kα mutations. These alternatives offer different mechanisms of action and have shown efficacy in recent clinical trials.

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Estrogen Receptor Antagonist

Gedatolisib + Fulvestrant +/- Palbociclib for Advanced Breast Cancer (VIKTORIA-1 Trial)

Phase 3

Recruiting

Research Sponsored by Celcuity Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate archival or fresh tumor tissue for the analysis of PIK3CA mutational status

Documented HER2 immunohistochemistry (IHC) negative as per ASCO-CAP 2018 guidance

Must not have

Bone only disease that is only blastic with no soft tissue component

Known and untreated, or active, brain or leptomeningeal metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 48 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a combination of drugs to treat advanced breast cancer that has not responded to other treatments. The drugs work by blocking growth signals, breaking down estrogen receptors, and stopping cell division. Tamoxifen is a commonly used drug that blocks estrogen receptors to treat breast cancer, but resistance to it often develops.

Who is the study for?

This trial is for adults with advanced or metastatic HR+/HER2- breast cancer who've progressed after CDK4/6 and aromatase inhibitor therapy. They must have a life expectancy of at least 3 months, ECOG status of 0-1, adequate organ function, and no pregnancy. Pre-menopausal women must agree to LHRH agonist treatment.

What is being tested?

The study tests gedatolisib plus fulvestrant with or without palbociclib against standard care in patients whose breast cancer has worsened despite previous treatments. It's an open-label Phase 3 trial where participants are randomly assigned to different drug combinations.

What are the potential side effects?

Potential side effects may include digestive issues, blood sugar changes (especially important for diabetics), hormonal imbalances due to LHRH agonists in pre-menopausal women, and possible reactions related to the immune system or liver functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can provide a recent or past sample of my tumor for PIK3CA mutation testing.

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My cancer is HER2 negative according to the latest guidelines.

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My cancer has grown or spread after my last treatment, confirmed by scans.

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I am not pregnant and will use birth control during and for 1 year after the study.

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I am fully active or can carry out light work.

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I have been diagnosed with advanced breast cancer.

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My cancer is positive for estrogen or progesterone receptors.

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My cancer progressed after treatment with CDK4/6 inhibitors and AI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is only in the bones and does not affect soft tissues.

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I have untreated brain or spinal cord cancer spread.

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I have a history of serious heart problems.

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My cancer has spread to my organs and is causing symptoms that could quickly become life-threatening.

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I have received chemotherapy and antibody drug treatments for my advanced disease.

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My blood pressure is not controlled, even with medication.

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I do not have Long QT syndrome or a family history of sudden death.

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I have been treated with a PI3K, Akt, or mTOR inhibitor before.

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I have type 1 diabetes or my type 2 diabetes is not under control.

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I have had more than two hormone therapy treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer

Secondary study objectives

Adverse Events

Clinical Benefit Rate (CBR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer

Duration of Response (DOR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Arm F - Patients with PIK3CA Mutation (MT)Experimental Treatment2 Interventions

Gedatolisib + Fulvestrant

Group II: Arm D - Patients with PIK3CA Mutation (MT)Experimental Treatment3 Interventions

Gedatolisib + Palbociclib + Fulvestrant

Group III: Arm B - Patients Lacking PIK3CA Mutations (WT)Experimental Treatment2 Interventions

Gedatolisib + Fulvestrant

Group IV: Arm A - Patients Lacking PIK3CA Mutations (WT)Experimental Treatment3 Interventions

Gedatolisib + Palbociclib + Fulvestrant

Group V: Arm E - Patients with PIK3CA Mutation (MT)Active Control2 Interventions

Alpelisib + Fulvestrant

Group VI: Arm C - Patients Lacking PIK3CA Mutations (WT)Active Control1 Intervention

Fulvestrant

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gedatolisib

2018

Completed Phase 1

~160

Palbociclib

2017

Completed Phase 3

~3790

Fulvestrant

2011

Completed Phase 3

~3510

0 / 18Eligibility criteria met

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

Gedatolisib, a PI3K/mTOR inhibitor, targets the PI3K/AKT/mTOR pathway to inhibit cancer cell growth and survival. Fulvestrant, an estrogen receptor antagonist, binds to and degrades estrogen receptors, reducing estrogen-driven cancer cell proliferation. Palbociclib, a CDK4/6 inhibitor, blocks cyclin-dependent kinases 4 and 6, preventing cancer cell division. These mechanisms are crucial for breast cancer patients as they offer targeted approaches to disrupt specific pathways essential for cancer cell growth, potentially improving treatment efficacy and outcomes.