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.

Estrogen Receptor Antagonist

Inavolisib Combination for Breast Cancer (INAVO120 Trial)

Madrid, Spain

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 3.7 years

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.

See full description

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.Check my eligibility

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.See study design

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

Select...

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

show original

Select...

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

show original

Select...

My breast cancer is hormone receptor positive and HER2 negative.

show original

Select...

I am fully active or can carry out light work.

show original

Exclusion Criteria

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

Select...

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

show original

Select...

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

show original

Select...

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

show original

Select...

My breast cancer is of a rare type called metaplastic.

show original

Select...

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

show original

Select...

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

show original

Select...

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

show original

Select...

I have received treatment for breast cancer that has spread.

show original

Select...

I have had leptomeningeal disease or carcinomatous meningitis.

show original

Select...

I need daily oxygen or have symptoms from lung disease.

show original

Select...

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

show original

Select...

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

show original

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3.7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3.7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3.7 years 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)

Secondary study objectives

Duration of Response (DOR)

Number of Participants With Adverse Events (AEs)

Overall Survival (OS)

+7 more

Side effects data

From 2024 Phase 2 trial • 252 Patients • NCT04632992

40%

Nausea

40%

Urinary tract infection

40%

Headache

20%

Acute hepatic failure

20%

Pneumonia

20%

Constipation

20%

Dental caries

20%

Fatigue

20%

Oedema

20%

Post procedural haemorrhage

20%

Underdose

20%

Blood bilirubin increased

20%

Neutrophil count decreased

20%

Platelet count decreased

20%

Weight decreased

20%

Arthralgia

20%

Back pain

20%

Muscular weakness

20%

Pain in extremity

20%

Confusional state

20%

Dyspnoea

20%

Anaemia

20%

Non-cardiac chest pain

20%

Oedema peripheral

20%

Peripheral swelling

20%

Overdose

20%

Decreased appetite

100%

80%

60%

40%

20%

Study treatment Arm

Arm C: Alectinib

Arm D: Ipatasertib

Arm B: Inavolisib (GDC-0077)

Arm I: Trastuzumab Emtansine + Tucatinib

Arm H: PH FDC SC + Chemotherapy

Arm J: Trastuzumab Emtansine + Atezolizumab

Arm K: Ipatasertib + Atezolizumab

Arm E: Atezolizumab + Chemotherapy

Arm F: Trastuzumab Emtansine + Atezolizumab

Arm G: PH FDC SC

Arm L: Ipatasertib + Atezolizumab

Arm M: Ipatasertib + Paclitaxel

Arm N: Atezolizumab + Tiragolumab

Arm O: Pralsetinib

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

~750

Fulvestrant

2011

Completed Phase 3

~4160

Palbociclib

2017

Completed Phase 3

~3910

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.