RecruitingPHASE2INTERVENTIONAL

A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer

This research study is investigating new treatment options for a common type of early-stage breast cancer. Specifically, it's for patients whose breast cancer is Estrogen Receptor-positive (ER+), HER2-negative, and has a specific gene alteration called a PIK3CA mutation. The study aims to find out if a new drug called Inavolisib, when given alongside existing treatments like Ribociclib and Letrozole, is safe and works well. The goal is to improve outcomes for patients with this type of cancer before they have surgery. It's a 'Phase 2' study, meaning researchers are still learning about how well the treatment works and what side effects it might have in a group of patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Hoffmann-La Roche

Enrolment target

Start

09 Sep 2025

Estimated completion

28 Sep 2027

Breast Cancer

What is this study about?

This study is for people who have been diagnosed with early-stage breast cancer. This means the cancer hasn't spread to other parts of the body, and it's either in Stage II or Stage III. Importantly, the study is focused on a specific kind of breast cancer: it must be Estrogen Receptor-positive (ER+), HER2-negative, and have a particular change in a gene called PIK3CA. These details are usually found through tests on your cancer cells.

The main aim is to test a new medicine called Inavolisib. Inavolisib is being given along with other standard treatments, Ribociclib and Letrozole, which are already used for breast cancer. The researchers want to see if this new combination of medicines can help shrink the tumour and make surgery more successful. They will also be looking closely at how safe the combination treatment is for patients.

Taking part in this study means you would receive treatment before having surgery. This is sometimes called 'neoadjuvant' treatment. By doing this, doctors can assess how well the medicines work to reduce the tumour size before it's removed. The information gathered from this study will help doctors understand better ways to treat this specific type of early breast cancer in the future.

Key takeaways

This study tests new drug combinations for early-stage breast cancer.
It's for a specific type: ER+, HER2-, with a PIK3CA gene mutation.
The new medicine, Inavolisib, is given with existing treatments.
Treatment happens before surgery to see its effect.
Regular check-ups and monitoring are part of taking part.
You can leave the study at any time.

Who may be eligible?

To join this study, you would need to have been diagnosed with early-stage breast cancer (Stage II or III). Your doctors would also need to confirm that your cancer is Estrogen Receptor-positive (ER+) and HER2-negative, which are common classifications for breast cancer. A crucial part of eligibility is that your cancer must show a specific gene change called a PIK3CA mutation, and your Ki-67 score (a measure of how quickly cancer cells are dividing) should be 5% or higher. You should also be planning to have breast surgery after the study treatments.

There are also some reasons why you wouldn't be able to join. For example, if your breast cancer has already spread to other parts of your body (Stage IV), or if you have a specific type called inflammatory breast cancer. You also wouldn't be able to join if you have certain other medical conditions, such as Type 1 diabetes, or Type 2 diabetes that needs ongoing medical treatment. If you've already had surgery or other treatments for the current breast cancer, you would also not be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have you been diagnosed with breast cancer that is Stage II or Stage III?
Has your doctor confirmed your cancer is ER-positive and HER2-negative?
Have tests shown your cancer has a PIK3CA gene mutation?
Are you planning to have breast surgery?
Do you have Type 1 diabetes or Type 2 diabetes requiring ongoing medication?
Have you already had treatment (like surgery or radiotherapy) for your current breast cancer?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive a new treatment combination involving Inavolisib, Ribociclib, and Letrozole. This treatment will be given before you have surgery for your breast cancer. You will have regular visits to the clinic for medical checks, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects. The exact schedule of visits and tests will be explained to you by the study team.

The duration of the treatment period within the study will vary, as it continues until it is time for your breast cancer surgery. After your surgery, the study team will continue to follow up with you to see how you are doing and to collect long-term information about your health and recovery. The total duration of your participation, including follow-up, will be clearly outlined by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from a new treatment combination that could be more effective than standard approaches for your specific type of breast cancer. However, there's no guarantee the treatment will work for you, and like all medicines, Inavolisib, Ribociclib, and Letrozole can cause side effects. These could range from mild to serious, and the study team will monitor you closely for any issues. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (30)

Community Clinical Trials
Verified postcode
Orange, United States· Recruiting
Hospital Aleman de Buenos Aires
Verified postcode
Buenos Aires, Argentina· Recruiting
Centro Médico Fleischer
Verified postcode
Buenos Aires, Argentina· Recruiting
Centro Oncologico Korben
City only
Ciudad Autonoma Buenos Aires, Argentina· Recruiting
Hospital Araujo Jorge
Verified postcode
Goiânia, Brazil· Recruiting
Hospital do Cancer de Pernambuco - HCP
Verified postcode
Recife, Brazil· Recruiting
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Verified postcode
Porto Alegre, Brazil· Recruiting
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
Verified postcode
São Paulo, Brazil· Recruiting
Sunnybrook Odette Cancer Centre
Verified postcode
Toronto, Canada· Recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM)
Verified postcode
Montreal, Canada· Recruiting
Jewish General Hospital
Verified postcode
Montreal, Canada· Recruiting
McGill University Health Center
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is PIK3CA-mutated breast cancer?

It's a type of breast cancer that has a specific change in a gene called PIK3CA. This gene change can sometimes make cancer cells grow differently.

What are Inavolisib, Ribociclib, and Letrozole?

Inavolisib is a new drug being tested. Ribociclib and Letrozole are medicines already used to treat breast cancer. This study is testing them together.

Why is the treatment given before surgery?

Giving treatment before surgery (called neoadjuvant treatment) can help shrink the tumour, making surgery easier, and allows doctors to see how well the medicine works.

Will I still need surgery if I join this study?

Yes, after completing the study treatment, you will still undergo breast surgery (either a mastectomy or breast-conserving surgery) as planned.

What happens after the treatment and surgery?

The study team will continue to follow up with you for a period to see how you are doing and to collect information about your long-term health.

How to find out more

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

global-roche-genentech-trials@gene.com 888-662-6728 (U.S. and Canada) Official trial record

Always speak to your GP or specialist before deciding to take part in a study.