Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

BYLieve: A phase II, multicenter, open-label, three-cohort, non-comparative study to assess the efficacy and safety of alpelisib plus fulvestrant or letrozole in patients withPIK3CA mutant, hormone receptor (HR) positive, HER2-negative advanced breast cancer (aBC), who have progressed on or after prior treatments.

This study, called BYLieve, is testing new treatment combinations for a type of advanced breast cancer. This is for adults whose cancer has a specific genetic change (called PIK3CA mutant), is hormone receptor-positive (HR+), and HER2-negative. Participants would have already tried other treatments that are no longer working. The main goal is to see how many people are still alive and their cancer hasn't gotten worse after six months on these new treatments. We will also be looking at how long people live without their cancer growing, how many people respond to the treatment, and any side effects. The medications being studied include alpelisib combined with either fulvestrant or letrozole.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Novartis Pharma AG

Enrolment target

Start

22 Mar 2024

Adult patients with PIK3CA mutant HR-positive HER2-negative advanced breast cancer

What is this study about?

The BYLieve study is a clinical trial that aims to find better treatments for a specific type of advanced breast cancer. This is for people whose cancer has spread and can no longer be cured, but treatment can help manage it. The focus is on breast cancer that has certain characteristics: it's hormone receptor-positive (meaning its growth is fueled by hormones), it's HER2-negative (meaning it doesn't have too much of a protein called HER2), and it has a particular change in its genes, known as a PIK3CA mutation. This mutation can sometimes make cancer harder to treat.

Participants in this study will have already received other treatments for their advanced breast cancer, and those treatments are no longer effective. The researchers are testing new combinations of medicines: alpelisib with fulvestrant, or alpelisib with letrozole. In some cases, other hormone-blocking medications like leuprorelin acetate or goserelin might also be used. The main reason for this study is to see how well these new drug combinations work in slowing down or stopping the cancer's growth.

The study will especially look at how many patients are alive and their cancer hasn't progressed (gotten worse) after six months of treatment. They will also collect information on how long people live overall, how long they live without their cancer growing, if the tumours shrink, and also whether there are any side effects from the treatments. By carefully studying these new combinations, doctors hope to find more effective ways to manage advanced breast cancer for people who have limited options.

Key takeaways

This study is for advanced breast cancer that has specific genetic features.
It tests new drug combinations for people whose previous treatments are no longer working.
The main goal is to see how many people live longer without their cancer growing.
You would receive either alpelisib with fulvestrant or alpelisib with letrozole.
Regular health checks and scans are part of participating.
You can stop participating at any time if you change your mind.

Who may be eligible?

This study is looking for adult patients, meaning anyone 18 years old or older, regardless of their gender. Your doctors will need to check if your breast cancer has a specific genetic change called PIK3CA mutation. Your cancer also needs to be hormone receptor-positive (HR-positive) and HER2-negative.

Crucially, you would have already received other treatments for your advanced breast cancer, and the cancer has continued to grow despite those treatments. There might be other medical criteria we haven't listed here, so the medical team will thoroughly review your health and medical history to make sure the study is a safe and suitable option for you.

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?
Has your doctor confirmed your breast cancer has a PIK3CA mutation?
Is your breast cancer hormone receptor-positive and HER2-negative?
Have you already had other treatments for advanced breast cancer which are no longer effective?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive one of the study medications, either alpelisib with fulvestrant or alpelisib with letrozole. You will have regular visits to the clinic for check-ups, where doctors will monitor your health, perform examinations, and take blood tests. They will also do scans to see how your cancer is responding to the treatment. This will help them understand if the treatment is working and if you are experiencing any side effects.

The study will follow your progress over several months, specifically looking at how your cancer changes over time. The exact number of visits and the full length of your participation will be explained in detail by the study team. You will have a chance to ask any questions you have about the schedule and what's involved before you agree to take part.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as access to new medications that aren't yet widely available, which could potentially help manage your cancer. However, there are also potential risks; the new drugs might have side effects, some of which could be serious or unexpected. The study team will explain all known side effects. You have the full right to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Denmark
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Unverified
Italy

Common questions

What is PIK3CA mutant breast cancer?

This means your cancer has a specific change in one of its genes, called PIK3CA. This change can sometimes affect how your cancer grows and responds to treatment.

What does 'hormone receptor positive' and 'HER2-negative' mean?

Hormone receptor positive means your cancer cells use hormones to grow. HER2-negative means your cancer doesn't have high levels of a protein called HER2, which guides certain other treatments.

What are alpelisib, fulvestrant, and letrozole?

These are different medications used to treat breast cancer. Alpelisib is a newer drug aimed at cancers with the PIK3CA mutation, while fulvestrant and letrozole are types of hormone therapy.

What does a 'Phase II' study mean?

A Phase II study means researchers are testing if a new treatment works and is safe in a larger group of people. If it shows promise, it might then go into a larger Phase III study.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, which means both you and your doctors will know exactly which combination of medications you are receiving as part of the trial.