Inavolisib for Breast Cancer

Recruiting at 13 trial locations

Overseen By Reference Study ID Number: BO45853 https://forpatients.roche.com/

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Must be taking: Endocrine therapy

Disqualifiers: Stage IV BC, Inflammatory BC, Bilateral BC, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of inavolisib, a new potential drug, when combined with other treatments for a specific type of breast cancer that has not been previously treated. The focus is on individuals with Stage II-III breast cancer that is estrogen receptor-positive and HER2-negative, with a specific PIK3CA gene mutation. Participants will receive various combinations of inavolisib, letrozole, and ribociclib over several treatment cycles. Ideal candidates for this trial have a confirmed PIK3CA mutation and tumors that are estrogen receptor-positive and HER2-negative, and are prepared for surgery after treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have Type 2 diabetes requiring ongoing treatment, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that inavolisib, used alone or with other breast cancer treatments, is generally safe. Studies indicate that patients have tolerated the treatment well, even those on it for a year or more. Reports mention that side effects are usually manageable, allowing doctors to control them if they occur. While some patients might experience side effects, the treatment remains safe for continued use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Inavolisib is unique because it targets the PI3K pathway, which is crucial for cancer cell growth and survival. This mechanism is different from the standard treatments for breast cancer, such as hormone therapies like letrozole or CDK4/6 inhibitors like ribociclib, which work by blocking hormone receptors or cell cycle proteins. Researchers are excited about inavolisib because it offers a new way to tackle cancer by directly interfering with a pathway that is often overactive in cancer cells. This could potentially improve outcomes for patients whose cancers are resistant to current therapies.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Research has shown that inavolisib may help treat breast cancer with a PIK3CA mutation. In this trial, participants will receive inavolisib alongside other treatments. Studies have found that combining inavolisib with treatments like palbociclib and fulvestrant can significantly increase survival rates. Specifically, patients who took inavolisib lived for a median of 34 months, compared to 27 months for those on a placebo. Inavolisib reduced the risk of death by more than 30% in some cases. These findings suggest that inavolisib could be an effective treatment option for patients with this type of breast cancer. ^{4 6 7 8 9}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for individuals with early-stage, PIK3CA-mutated, ER-positive, HER2-negative breast cancer who haven't been treated yet. Specific details about inclusion and exclusion criteria are not provided but typically would involve health status and other medical conditions.

Inclusion Criteria

I am eligible for initial hormone therapy before surgery.

My cancer has a PIK3CA mutation.

My tumor is estrogen receptor-positive according to ASCO/CAP guidelines.

Exclusion Criteria

My breast cancer has spread to other parts of my body.

My breast cancer is inflammatory (stage T4d).

I have breast cancer in both breasts.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive inavolisib combination therapies in cycles, with varying regimens across cycles 1-6

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Inavolisib

Trial Overview The study tests the safety and effectiveness of inavolisib combined with ribociclib and letrozole in treating certain types of breast cancer. It's focused on those who have specific genetic mutations and hormone receptor statuses.

How Is the Trial Designed?

Group I: Arm C Experimental Treatment 3 Interventions

Participants will receive a starting regimen of ribociclib PO QD from Day 1 to 21 and letrozole PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + letrozole as follows: inavolisib and letrozole PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days).

Group II: Arm B Experimental Treatment 3 Interventions

Participants will receive a starting regimen of inavolisib and letrozole PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + letrozole as follows: inavolisib and letrozole PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days).

Group III: Arm A Experimental Treatment 3 Interventions

Participants will receive inavolisib and letrozole orally (PO) once a day (QD) from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 1-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days).

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40454641/

Overall Survival with Inavolisib in PIK3CA-Mutated ... Conclusions: Treatment with inavolisib plus palbociclib-fulvestrant led to a significant overall survival benefit, as compared with placebo plus ...

2. roche.com roche.com/media/releases/med-cor-2025-05-31

New data show Roche's Itovebi significantly extended ... The ItovebiTM (inavolisib)-based regimen reduced the risk of death by more than 30% in people with PIK3CA-mutated HR-positive, HER2-negative ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.1003

INAVO120: Phase III trial final overall survival (OS) analysis ... Median OS was 34.0 mo (95% CI = 28.4–44.8) in the INAVO arm and 27.0 mo (95% CI = 22.8–38.7) in the PBO arm (stratified hazard ratio 0.67; 95% ...

4. onclive.com onclive.com/view/inavo120-final-analysis-translating-overall-survival-data-into-clinical-practice

INAVO120 Final Analysis: Translating Overall Survival ... The final overall survival analysis revealed a median overall survival of 34 months in the inavolisib group compared to 27 months in the placebo ...

5. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2501796

Overall Survival with Inavolisib in PIK3CA-Mutated ... Treatment with inavolisib plus palbociclib–fulvestrant led to a significant overall survival benefit, as compared with placebo plus palbociclib–fulvestrant.

6. esmoopen.com esmoopen.com/article/S2059-7029(25)01172-X/fulltext

Safety overview and management of inavolisib alone ... Safety results showed a manageable safety/tolerability profile of inavolisib, including in patients treated for ≥1 year. •. These results ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40513140/

Safety overview and management of inavolisib alone ... Conclusions: Inavolisib alone or in combination with HR-positive breast cancer therapies demonstrated a manageable safety and tolerability ...

8. itovebi-hcp.com itovebi-hcp.com/side-effects/summary.html

Itovebi Regimen Safety Profile See safety data from the INAVO120 clinical trial of Itovebi™ (inavolisib). Visit our website. See full safety for more information.

9. asco.org asco.org/abstracts-presentations/ABSTRACT363596

Long-term safety of inavolisib (GDC-0077) in an ongoing ... Conclusions: These data indicate acceptable long-term tolerability. The safety profile of pts on study treatment with inavolisib alone or in combo with ...