Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A randomized, double-blind, parallel-group, multicentre, phase II study to compare the efficacy and tolerability of fulvestrant (FaslodexTM) 500mg with placebo and fulvestrant (FaslodexTM) 500mg in combination with PD-0332991 (Palbociclib) as first line treatment for postmenopausal women with hormone receptor-positive metastatic breast cancer, who have completed at least 5 years of adjuvant endocrine therapy and remained disease free for more than 12 months following its completion or have de novo metastatic disease. "The FLIPPER Study"

The FLIPPER Study is a research project for women who have breast cancer that has spread to other parts of their body (metastatic breast cancer). These women have a specific type of cancer that is sensitive to hormones and have already finished at least five years of hormone treatment, or their cancer has appeared for the first time as metastatic. The study aims to compare how well an existing treatment, Faslodex, works on its own against Faslodex combined with a new drug called Palbociclib. Researchers want to find out if the combination treatment can stop the cancer from growing for longer. They will also look at side effects, how long people live, and their quality of life.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fundacion Grupo Espanol De Investigacion En Cancer De Mama

Enrolment target

189

Start

23 Oct 2024

Metastatic breast cancer

What is this study about?

The FLIPPER Study is a vital clinical trial for women living with metastatic breast cancer that is sensitive to hormones. This type of breast cancer grows in response to hormones, and treatments that block these hormones are often used. Many women in the study would have completed a long course of hormone treatment and remained cancer-free for a while, or they might be experiencing metastatic breast cancer for the first time.

The main goal of this study is to see if combining a standard treatment, Faslodex, with a newer drug, Palbociclib, is more effective than Faslodex alone in stopping the cancer from growing. Faslodex works by blocking estrogen, a hormone that can fuel breast cancer growth. Palbociclib works differently; it aims to stop cancer cells from dividing and growing. By combining these two treatments, doctors hope to achieve a more powerful effect against the cancer.

Researchers will carefully monitor participants to see how long it takes for the cancer to show signs of growing again. They will also look at how many people respond to the treatment (meaning their cancer shrinks or disappears), how long they live, and importantly, how their quality of life is affected. This study is designed to gather important information that could lead to better treatment options for women with this type of breast cancer.

Key takeaways

This study is for postmenopausal women with specific types of metastatic breast cancer.
It compares Faslodex alone with Faslodex combined with Palbociclib.
The main goal is to see if the combination treatment stops cancer growth for longer.
Researchers will also track side effects and quality of life.
Participation involves regular check-ups and medical tests.
You have the right to leave the study at any time.

Who may be eligible?

This study is specifically designed for women who have gone through menopause. You would also need to have breast cancer that has spread to other parts of your body (this is called metastatic breast cancer), and this cancer must be sensitive to hormones.

To be considered, you should have already finished at least five years of hormone treatment for your breast cancer and remained cancer-free for over a year after stopping that treatment. Alternatively, your breast cancer might be new and already be metastatic when it was first diagnosed.

To find out if this study is suitable for you, your doctors will carry out some checks and tests to make sure you meet all the specific requirements. They will be able to discuss your individual situation with 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 a woman who has gone through menopause?
Do you have breast cancer that has spread to other parts of your body?
Is your breast cancer sensitive to hormones?
Have you completed at least 5 years of hormone treatment and been cancer-free for over a year after that, OR is your metastatic breast cancer newly diagnosed?
Are you 18 years old or older?

Answer every question to see your result.

What does participation involve?

If you choose to take part in "The FLIPPER Study," you will be assigned to receive either Faslodex on its own or Faslodex combined with Palbociclib. Neither you nor your doctor will know which treatment you are receiving. Faslodex is given as an injection, while Palbociclib is a tablet you take by mouth.

You will have regular hospital visits for check-ups, blood tests, and scans (like CT scans or X-rays) to monitor your health and how the treatment is working. These tests will help doctors see if the cancer is growing, shrinking, or staying the same. You will also be asked about how you are feeling and how the treatment is affecting your daily life. The total duration of your participation will depend on how you respond to the treatment and the study's requirements.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new and promising treatments before they are widely available. Your health will also be closely monitored by a team of experts. However, there are also potential risks; the treatments might not work for everyone, and you might experience side effects, some of which could be serious. The research team will explain all known and potential side effects in detail. Remember, you have the right to withdraw from 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
Spain
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Unverified
Ireland

Common questions

What is metastatic breast cancer?

Metastatic breast cancer means that the cancer cells have spread from the breast to other parts of your body, like the bones, lungs, or liver.

What does 'hormone receptor-positive' mean?

It means the cancer cells have special proteins (receptors) that attach to hormones like estrogen, which can make the cancer grow. Treatments that block these hormones can be effective.

What are Faslodex and Palbociclib?

Faslodex is a drug that blocks the action of estrogen, while Palbociclib is a newer drug that aims to stop cancer cells from dividing and growing.

What is a 'Phase II' study?

A Phase II study is one of the stages of a clinical trial. It means researchers are looking more closely at how well a new treatment works and its safety, usually in a larger group of people than earlier studies.

Will I know which treatment I am getting?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know whether you are receiving Faslodex alone or the combination of Faslodex and Palbociclib. This helps ensure unbiased results.