Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A phase Ib study of Ipatasertib, an AKT inhibitor, in combination with Pertuzumab plus Trastuzumab in patients with PIK3CA-mutant, HER2-positive locally advanced or metastatic breast cancer.

This research study is for people with advanced breast cancer that has spread or is locally advanced. Specifically, it's for those whose cancer has a certain genetic change (PIK3CA mutant) and high levels of a protein called HER2. These patients are already receiving a type of maintenance therapy with Herceptin (trastuzumab) and Perjeta (pertuzumab) after their initial treatment for advanced disease. The study aims to find the right dose of a new experimental drug called ipatasertib when combined with Herceptin and Perjeta. Researchers want to understand how safe this combination is and how well patients tolerate it, as well as if it helps to control the cancer. This is an early-stage study to gather important information before larger studies are done.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Solti Group

Enrolment target

Start

25 Jun 2024

Patients with PIK3CA-mutant HER2-positive locally advanced or metastatic breast cancer candidates to receive maintenance therapy with trastuzumab plus pertuzumab (HP) after first line treatment for metastatic disease with a taxane or vinorelbine plus HP.

What is this study about?

This study is looking into new ways to treat a specific type of advanced breast cancer. Advanced breast cancer means the cancer has spread from where it started to other parts of the body, or it's grown into nearby tissues. In this study, they're focusing on breast cancer that has two particular features: it has a genetic change called a PIK3CA mutation, and it has high levels of a protein called HER2. These features can sometimes make the cancer harder to treat.

Patients in this study will already be receiving standard treatments called Herceptin (trastuzumab) and Perjeta (pertuzumab) for their advanced breast cancer. These are known treatments that work by targeting the HER2 protein. The study wants to see if adding a new experimental drug, called ipatasertib, to this existing treatment can be helpful. Ipatasertib works differently, by targeting another pathway in cancer cells. The goal is to see if combining these treatments can be more effective.

This is a 'Phase Ib' study, which means it's an early stage of research. The main purpose is to figure out the safest dose of ipatasertib when given with Herceptin and Perjeta. Researchers will carefully watch for any side effects and how well people tolerate the new drug combination. They will also start to look at how much the treatment helps to control the cancer. The information gathered from this study will help decide if this combination should be tested in larger studies in the future.

Key takeaways

This study evaluates a new drug, ipatasertib, for advanced breast cancer.
It's for people with specific cancer features: PIK3CA-mutant and HER2-positive.
Participants will already be receiving Herceptin and Perjeta.
The main aim is to find the safest dose of ipatasertib and check for side effects.
It's an early-stage study to gather initial safety and effectiveness information.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To join this study, people generally need to be at least 18 years old. The study is open to both men and women.

More specifically, you would need to have breast cancer that is considered 'locally advanced' (meaning it has grown into nearby tissues but hasn't necessarily spread far) or 'metastatic' (meaning it has spread to other parts of the body). A key requirement is that your cancer must have a specific genetic change called 'PIK3CA mutant' and also have high levels of a protein called 'HER2'. Your doctor would have tested for these things.

You also need to be currently receiving or planned to receive ongoing treatment with Herceptin and Perjeta. This usually happens after you've had an initial treatment like chemotherapy (taxane or vinorelbine) for your advanced breast cancer. The study is for people who are suitable for this 'maintenance' part of their treatment plan.

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.

Are you 18 years old or older?
Do you have locally advanced or metastatic breast cancer?
Has your doctor confirmed your cancer is PIK3CA-mutant and HER2-positive?
Are you currently receiving or planning to receive Herceptin and Perjeta treatment?
Have you already had initial treatment (like chemotherapy) for your advanced breast cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study drugs according to a specific schedule. This schedule will include your regular infusions of Herceptin and Perjeta, plus the new drug ipatasertib. Ipatasertib will likely be taken by mouth, but the exact way and how often will be explained by the study team.

Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. These visits are important for the doctors to make sure the treatment is safe for you and to see if it's working. The first few weeks are especially important for checking for side effects and finding the right dose.

While the detailed duration isn't specified, studies like this often involve close monitoring for several months or as long as the treatment is beneficial and tolerable. The specific tests and number of visits will be fully explained by the study team if you are considering joining.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as access to a new treatment combination that isn't widely available yet, which could potentially help your cancer. However, there's no guarantee it will work for everyone, and it might not be better than standard treatments. As with any medication, there are potential risks and side effects. Ipatasertib is a new drug, and while researchers try to understand all possible side effects, some might be unknown or unexpected. You will be closely monitored for any side effects, especially stomach upset like diarrhoea, as this is something doctors are looking out for with this drug. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is PIK3CA-mutant breast cancer?

This means your breast cancer cells have a specific change in a gene called PIK3CA. This change can sometimes make the cancer grow.

What does HER2-positive mean?

HER2-positive means your cancer cells have high levels of a protein called HER2, which helps them grow. There are targeted treatments for HER2-positive cancer.

Are Herceptin and Perjeta standard treatments?

Yes, Herceptin (trastuzumab) and Perjeta (pertuzumab) are standard, approved treatments for HER2-positive breast cancer.

What is ipatasertib?

Ipatasertib is a new, experimental drug that works differently from Herceptin and Perjeta, and it's being tested to see if it can improve treatment when combined.

What is the main goal of this study?

The main goal is to find the safest dose of ipatasertib when given with Herceptin and Perjeta, and to see what side effects people might experience.