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, and hyperglycemia. Chemotherapy agents like paclitaxel can cause alopecia, granulocytopenia, and neurotoxicity. Targeted therapies, such as those involving fulvestrant, may lead to increased risks of adverse events including severe skin reactions and gastrointestinal issues. It is important for patients to 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 treatments for breast cancer that target the PI3K pathway, similar to inavolisib. One notable example is alpelisib, an alpha-specific PI3K inhibitor, which is approved for use in combination with fulvestrant for hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer. This approval was based on the results of a phase III trial demonstrating its efficacy in this patient population. Other targeted therapies for breast cancer include CDK4/6 inhibitors like palbociclib, which is often used in combination with endocrine therapy such as fulvestrant.

What other types of research exist?

Promising novel alternatives to Inavolisib for breast cancer patients include: 1) Alpelisib (another PI3K inhibitor) in combination with endocrine therapy, 2) CDK4/6 inhibitors like Abemaciclib, Ribociclib, and Palbociclib, 3) PARP inhibitors such as Olaparib and Talazoparib for patients with BRCA mutations, and 4) Immunotherapy agents like Pembrolizumab for PD-L1 positive tumors. These alternatives have shown efficacy in various clinical trials and are considered promising for treatment in 2024.

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Estrogen Receptor Antagonist

Inavolisib Combination for Breast Cancer (INAVO120 Trial)

Phase 2 & 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)

Metastatic or locally advanced disease not amenable to curative therapy

Must not have

Active inflammatory or infectious conditions in either eye, or any eye conditions expected to require surgery during the study treatment period

Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial tests a new drug combination (inavolisib, palbociclib, and fulvestrant) for patients with a specific type of advanced breast cancer that got worse after hormone therapy. The treatment aims to stop cancer cells from growing and spreading by attacking them in different ways.

Who is the study for?

This trial is for adults with a specific mutation in their breast cancer cells (PIK3CA), whose cancer has worsened during or after hormone therapy and haven't had treatment for advanced disease. They must have measurable disease, provide tissue samples, have good organ function, not be pregnant or breastfeeding, and can't have untreated brain metastases or prior treatments that are excluded.

What is being tested?

The study tests the effectiveness of Inavolisib combined with Palbociclib and Fulvestrant versus a placebo plus Palbociclib and Fulvestrant in treating certain advanced breast cancers. It aims to see if adding Inavolisib helps patients better than the standard treatment alone.

What are the potential side effects?

Possible side effects include reactions at the injection site, nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, liver issues indicated by abnormal blood tests, eye inflammation or infections requiring surgery.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has a specific genetic change in the PIK3CA gene.

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My cancer has spread and cannot be cured with surgery or radiation.

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My breast cancer is hormone receptor positive and HER2 negative.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I do not have active eye infections or conditions needing surgery soon.

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I have not had major surgery or a significant injury in the last 28 days.

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I am on long-term steroids or drugs that suppress my immune system.

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My breast cancer is of a rare type called metaplastic.

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I have a history of inflammatory bowel disease or currently have active bowel inflammation.

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I have Type 2 diabetes and am on treatment, or I have a history of Type 1 diabetes.

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I have not taken drugs targeting the PI3K-AKT-mTOR pathway.

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I have received treatment for breast cancer that has spread.

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I have had leptomeningeal disease or carcinomatous meningitis.

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I need daily oxygen or have symptoms from lung disease.

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I have had significant radiation therapy or a bone marrow transplant.

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I haven't taken any experimental drugs in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Inavolisib + Palbociclib + FulvestrantExperimental Treatment3 Interventions

Participants will receive inavolisib, palbociclib, and fulvestrant.

Group II: Placebo + Palbociclib + FulvestrantPlacebo Group3 Interventions

Participants will receive placebo, palbociclib, and fulvestrant.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Inavolisib

2021

Completed Phase 2

~260

Fulvestrant

2011

Completed Phase 3

~3890

Palbociclib

2017

Completed Phase 3

~3880

0 / 16Eligibility 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

Breast cancer treatments often target specific pathways involved in cancer cell growth and survival. PI3K inhibitors, like Inavolisib, block the PI3K pathway, which is frequently mutated in breast cancer, thereby inhibiting tumor growth and survival. CDK 4/6 inhibitors, such as palbociclib, prevent cancer cells from proliferating by halting the cell cycle. Hormone therapies, including fulvestrant, block estrogen receptors or reduce estrogen production, which is crucial for hormone receptor-positive breast cancer. These targeted treatments are essential as they offer more personalized and effective options, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

Promising novel therapies for the treatment of endometrial cancer.New drugs for breast cancer.Highlights from the 42nd annual meeting of the American Society of Clinical Oncology Atlanta, GA, USA, 2-6 June 2006.

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Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,444 Previous Clinical Trials

1,092,797 Total Patients Enrolled

158 Trials studying Breast Cancer

90,325 Patients Enrolled for Breast Cancer

Clinical TrialsStudy DirectorHoffmann-La Roche

2,212 Previous Clinical Trials

892,091 Total Patients Enrolled

136 Trials studying Breast Cancer

70,979 Patients Enrolled for Breast Cancer

Media Library

Fulvestrant (Estrogen Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04191499 — Phase 2 & 3

Breast Cancer Research Study Groups: Placebo + Palbociclib + Fulvestrant, Inavolisib + Palbociclib + Fulvestrant

Breast Cancer Clinical Trial 2023: Fulvestrant Highlights & Side Effects. Trial Name: NCT04191499 — Phase 2 & 3

Fulvestrant (Estrogen Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04191499 — Phase 2 & 3

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