Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer

This research study is for women aged 18 to 100 with advanced breast cancer that is Estrogen Receptor-positive (ER+). It's testing new combinations of medicines: LEE011, BYL719, and letrozole. The main goals are to find the safest and most effective doses of these combinations, particularly whether using two or three drugs together works best. Doctors want to understand how well these new treatments work and if they help shrink tumours. This is an important step in finding better ways to treat ER+ breast cancer, particularly in cases where the cancer has spread or is locally advanced. About 270 women are expected to take part across different medical centres.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Novartis Pharmaceuticals

Enrolment target

255

Start

22 Oct 2013

Estimated completion

26 Feb 2027

Breast Cancer

What is this study about?

This study is designed to explore new ways of treating a common type of breast cancer called Estrogen Receptor-positive (ER+) breast cancer. This is when breast cancer cells grow in response to the female hormone oestrogen. When this cancer has spread to other parts of the body (advanced) or is locally advanced, doctors are always looking for better treatments.

Specifically, this research is looking at two new drugs, LEE011 and BYL719. These drugs aim to stop cancer cells from growing in different ways. They are being tested both alone and in combination with an existing breast cancer drug called letrozole, which works by reducing oestrogen levels in the body. The study's main purpose is to find the right doses for these new combinations and to understand how safe and effective they are. It starts by carefully increasing the dose to find the best level, then expands to see how well patients respond.

By taking part, women could help doctors learn more about these new drug combinations. This knowledge could lead to improved treatment options for future patients with ER+ breast cancer. The study is being carried out in different hospitals and clinics, welcoming around 270 women to contribute to this important research.

Key takeaways

New drug combinations are being tested for advanced ER+ breast cancer.
The study aims to find safe and effective doses of LEE011 and BYL719 with letrozole.
Around 270 women aged 18-100 will participate.
This research could lead to better treatments for future patients.
Your health will be closely monitored if you join.

Who may be eligible?

This study is for women aged 18 to 100 who have advanced or locally advanced breast cancer that is Estrogen Receptor-positive (ER+) or Progesterone Receptor-positive. You must have gone through menopause.

There are some conditions that might mean you can't join. For example, if your breast cancer has too much of a protein called HER2, or if you have active cancer in your brain, or if you've had major surgery very recently. You also can't take part if you have certain other serious health problems like pancreatitis, uncontrolled diabetes, or heart problems. If you've had another cancer recently (within 3 years) or are taking hormone replacement therapy that you can't stop, you also won't be able to join.

Your study doctor will carefully check all your medical details to see if this study is right for you and if you meet all the requirements for taking part.

Quick self-check

Are you a woman aged 18 to 100?
Do you have advanced or locally advanced ER+ breast cancer?
Are you postmenopausal?
Do you have HER2-negative breast cancer?
Do you not have active cancer in your brain or certain other serious health conditions?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will receive treatment with one of the drug combinations being tested. This will involve regular visits to the hospital or clinic for assessments, which typically include blood tests, physical examinations, and scans to check how you're responding to the treatment and to monitor for any side effects. You will receive the study medication regularly, as prescribed by the research team.

Initially, the study focuses on finding the right dose, so your treatment might start at a lower dose and then be adjusted. The study team will explain how often you'll need to visit and what each visit will involve. While the total duration isn't specified, you will likely continue treatment and follow-up for as long as it is working for you or until the study concludes. All your medical care related to the study will be provided as part of your participation.

Potential risks and benefits

Participating in a clinical trial might offer potential benefits, such as access to new treatments before they are widely available, and close monitoring by medical experts. However, there are also potential risks, as these are new drug combinations and side effects can occur, some of which may be serious, or the treatment may not work for you. The research team will explain all known and potential risks in detail before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (25)

Univ of California at San Diego Moores Cancer Ctr
San Diego, United States
UCSF Medical Center
San Francisco, United States
H Lee Moffitt Cancer Center and Research Institute
Tampa, United States
Massachusetts General Hospital SC-5
Boston, United States
Massachusetts General Hospital
Boston, United States
Sarah Cannon Research Institute
Nashville, United States
Vanderbilt University Medical Ctr
Nashville, United States
Texas Oncology
Amarillo, United States
Mays Cancer Ctr Uthsa Mdacc
San Antonio, United States
Northwest Medical Specialties
Tacoma, United States
Novartis Investigative Site
Westmead, Australia
Novartis Investigative Site
Parkville, Australia

+13 more sites — see the official record for the full list.

Common questions

What type of breast cancer is this study for?

This study is specifically for women with advanced or locally advanced breast cancer that is Estrogen Receptor-positive (ER+) or Progesterone Receptor-positive.

What are LEE011 and BYL719?

These are new drugs being tested in combination with an existing drug, letrozole, to see if they can better treat breast cancer.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, which means both you and your doctors will know which combination of drugs you are receiving.

How long will I be in the study if I join?

The study involves ongoing treatment and regular check-ups. You will continue as long as the treatment is helping you or until the study completes. The exact duration will be discussed with you.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, and this will not affect your future medical care.