What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those involving PI3K inhibitors like Inavolisib, often have side effects such as diarrhea, rash, nausea, hyperglycemia, and fatigue. For example, in the BELLE-4 trial, buparlisib (another PI3K inhibitor) combined with paclitaxel frequently caused diarrhea, alopecia, rash, nausea, and hyperglycemia. Similarly, capivasertib, another PI3K pathway inhibitor, was associated with diarrhea, fatigue, and stomatitis. These side effects are important considerations when evaluating the safety and efficacy of these treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that involve PI3K inhibitors, similar to Inavolisib. One notable example is alpelisib, which is approved for use with fulvestrant in hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer. This approval was based on a phase III trial demonstrating its efficacy. Other treatments for breast cancer include various targeted therapies and chemotherapies, but alpelisib is specifically relevant as a PI3K inhibitor.

What other types of research exist?

Promising novel alternatives to Inavolisib for breast cancer patients in 2024 include: 1) Trastuzumab Deruxtecan (Enhertu), an antibody-drug conjugate targeting HER2-positive breast cancer, which has shown significant efficacy in clinical trials. 2) Tucatinib (Tukysa), a HER2-targeted tyrosine kinase inhibitor, often used in combination with trastuzumab and capecitabine for advanced HER2-positive breast cancer. 3) Sacituzumab Govitecan (Trodelvy), an antibody-drug conjugate targeting Trop-2, approved for metastatic triple-negative breast cancer but also showing promise in other subtypes. These alternatives offer targeted approaches with potential for improved outcomes.

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Monoclonal Antibodies

Inavolisib + Phesgo for Breast Cancer

Phase 3

Recruiting

Research Sponsored by Hoffmann-La Roche

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 day 1 of cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with pro collection and survival follow up visit every 6 months (up to 111 months). each cycle is 21 days.

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new drug called inavolisib combined with Phesgo, which includes three existing drugs. It targets patients with untreated HER2-positive advanced breast cancer. Inavolisib works by blocking growth signals in cancer cells, while Phesgo targets a protein on these cells to stop their growth and spread.

Who is the study for?

This trial is for adults with HER2-positive advanced breast cancer that hasn't been treated yet. They should have a certain gene mutation (PIK3CA), good heart function, and no diabetes requiring systemic treatment. People who've had specific eye conditions, severe liver disease, lung problems like pneumonitis, or inflammatory bowel disease can't join.

What is being tested?

The study tests the safety and effectiveness of Inavolisib combined with Phesgo against a placebo with Phesgo after initial therapy. It's for those whose breast cancer has spread or can't be surgically removed.

What are the potential side effects?

Possible side effects include reactions to the drug infusion, changes in blood counts affecting organ functions, potential worsening of diabetes if present, eye inflammation risks, and possible exacerbation of liver or lung conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 of cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with pro collection and survival follow up visit every 6 months (up to 111 months). each cycle is 21 days.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 of cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with pro collection and survival follow up visit every 6 months (up to 111 months). each cycle is 21 days.

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with pro collection and survival follow up visit every 6 months (up to 111 months). each cycle is 21 days. for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Mean and Mean Changes from Baseline Score in Function and Health-Related Quality of Life (HRQoL)

Awards & Highlights

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Maintenance Therapy: Inavolisib plus PhesgoExperimental Treatment3 Interventions

Participants will be administered the treatments as outlined in the interventions section.

Group II: Induction Therapy: Phesgo plus Taxane-Based ChemotherapyExperimental Treatment2 Interventions

Participants will be administered the treatments as outlined in the interventions section.

Group III: Maintenance Therapy: Placebo plus PhesgoActive Control3 Interventions

Participants will be administered the treatments as outlined in the interventions section.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Inavolisib

2021

Completed Phase 2

~680

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

Breast cancer treatments often target specific molecular pathways involved in tumor growth and survival. For example, Inavolisib is a PI3K inhibitor that blocks the PI3K/AKT/mTOR pathway, which is frequently activated in breast cancer, leading to reduced tumor cell proliferation and survival. Other common treatments include HER2 inhibitors like trastuzumab, which target the HER2 receptor to prevent cell growth, and hormone therapies that block estrogen receptors in hormone receptor-positive cancers. Understanding these mechanisms is crucial for breast cancer patients as it allows for personalized treatment plans that target the specific pathways driving their cancer, potentially improving outcomes and reducing side effects.

Challenges in the diagnosis and management of cervical neuroendocrine carcinoma.[Trastuzumab (Herceptin) and breast cancer: mechanisms of resistance].