What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as Alpelisib (a PI3K inhibitor) and Enzalutamide (an androgen receptor inhibitor), have distinct side effect profiles. Alpelisib is known to cause hyperglycemia, rash, diarrhea, and liver function abnormalities. Enzalutamide can lead to fatigue, hot flashes, hypertension, and cardiovascular issues. Additionally, hormone therapies and targeted treatments often result in side effects like bone density loss, fractures, and cardiovascular risks. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several drugs targeting the PI3K/AKT/mTOR pathway for the treatment of breast cancer. 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 another drug in this pathway, approved for use with exemestane in similar breast cancer subtypes. While Enzalutamide, an androgen receptor inhibitor, is primarily used in prostate cancer, its combination with other therapies is being explored in clinical trials for breast cancer. These approvals highlight the ongoing efforts to target specific molecular pathways in breast cancer treatment.

What other types of research exist?

Promising novel alternatives for breast cancer treatment in 2024 include: 1) Sacituzumab Govitecan, an antibody-drug conjugate targeting Trop-2, which has shown efficacy in triple-negative breast cancer. 2) Trastuzumab Deruxtecan, another antibody-drug conjugate targeting HER2, effective in HER2-positive breast cancer. 3) PARP inhibitors like Olaparib and Talazoparib, particularly for patients with BRCA mutations. 4) CDK4/6 inhibitors such as Abemaciclib, Palbociclib, and Ribociclib, which are effective in HR-positive, HER2-negative breast cancer.

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PI3K Inhibitor

Alpelisib + Enzalutamide for Breast Cancer

Phase 1

Waitlist Available

Led By Meghan Karuturi

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 16 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial tests the combination of alpelisib and enzalutamide in patients with advanced breast cancer that has specific markers. The drugs work together to block cancer cell growth and reduce hormone levels, aiming to improve treatment outcomes. Alpelisib is a unique drug approved for the treatment of patients with estrogen receptor-positive metastatic breast cancer.

Who is the study for?

This trial is for adults with metastatic breast cancer that's hormone-receptor positive or triple-negative, and not suitable for surgery/radiation. Participants must have stable health, meet specific blood/lab criteria, and not be pregnant or breastfeeding. They should agree to use effective contraception if of childbearing potential.

What is being tested?

The trial tests the combination of Alpelisib and Enzalutamide in patients with advanced breast cancer. It aims to find the best dose while assessing side effects. Alpelisib blocks enzymes needed for tumor growth; Enzalutamide lowers body's androgen to combat cancer cell growth.

What are the potential side effects?

Potential side effects include reactions related to immune system, gastrointestinal issues affecting drug absorption, uncontrolled diabetes risks due to altered glucose levels, fatigue from anemia or other blood-related changes, liver function alterations, and possible skin sensitivity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 weeks for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Clinical benefit rate (CBR) (complete response or partial response + prolonged stable disease)

Incidence of adverse events

Profession-free survival (PFS)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (alpelisib, enzalutamide)Experimental Treatment2 Interventions

Patients receive alpelisib PO and enzalutamide PO on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alpelisib

FDA approved

Enzalutamide

FDA approved

Do I qualify?Apply below to find out

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

Alpelisib, a PI3K inhibitor, targets the PI3K/AKT/mTOR pathway to reduce tumor cell proliferation and induce apoptosis, while Enzalutamide, an androgen receptor inhibitor, blocks androgens that promote cancer cell growth. These targeted therapies are crucial for breast cancer patients as they offer more effective treatment options based on the specific molecular characteristics of their tumors.

Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.PIK3CA and MAP3K1 alterations imply luminal A status and are associated with clinical benefit from pan-PI3K inhibitor buparlisib and letrozole in ER+ metastatic breast cancer.Endocrine therapy for early breast cancer.