Active not recruitingPHASE3INTERVENTIONAL

A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer

This research is for women with advanced breast cancer that is hormone receptor positive (HR+) and HER2 negative (meaning it doesn't have high levels of a specific protein called HER2). The main goal is to see how well a new drug, abemaciclib, works when given with another drug called fulvestrant, compared to fulvestrant alone. The study will look at how long people live without their cancer getting worse. Some participants will get abemaciclib plus fulvestrant, while others will get fulvestrant plus a dummy drug (placebo). There's also a group who haven't had hormone therapy before, who will all receive abemaciclib plus fulvestrant. Each person in the study will be involved for about nine months.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

669

Start

22 Jul 2014

Estimated completion

01 Dec 2027

Breast Neoplasms

Results

Results from this study

Posted March 2018

Results have been published for this study.

Primary outcome

Progression-Free Survival (PFS)

PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.

Full results on the registry

What is this study about?

This clinical trial is designed for women who have advanced breast cancer that is hormone receptor positive (HR+) and HER2 negative. This type of cancer means it relies on hormones to grow and doesn't have too much of a protein called HER2. The term 'advanced' means the cancer has spread beyond the original site or cannot be removed completely by surgery.

The main aim of this study is to compare two treatment approaches. One group of participants will receive a new drug called abemaciclib along with an existing treatment called fulvestrant. The other group will receive fulvestrant plus a 'fake' drug called a placebo. By doing this, researchers can find out if adding abemaciclib helps slow down the cancer's growth more effectively than fulvestrant alone. The study will specifically measure how long people live without their cancer getting worse, which is known as 'progression-free survival'.

For some participants who have not had hormone therapy for their cancer before (this is called 'endocrine naïve'), everyone in that group will receive the combination of abemaciclib and fulvestrant. This part of the study will help understand how the new drug performs in people earlier in their treatment journey. The overall goal is to find better ways to treat this type of breast cancer and improve outcomes for patients.

Key takeaways

This study evaluates abemaciclib plus fulvestrant for advanced HR+, HER2- breast cancer.
It aims to see if the new combination helps patients live longer without their cancer growing.
You might receive the new combination or fulvestrant with a dummy pill (placebo).
Participation involves regular clinic visits, tests, and taking study medication.
The active treatment and assessment period for each participant is around nine months.
You must be postmenopausal and have progressed after prior hormone therapy for your cancer.

Who may be eligible?

To join this study, you need to be a woman with breast cancer that is hormone receptor positive and HER2 negative. This means your cancer grows because of hormones and doesn't have high levels of a protein called HER2. Your cancer should also be advanced, meaning it's spread locally or to other parts of the body, and surgery isn't a good option anymore.

You would be considered if your cancer has either come back while you were on or within a year of finishing hormone therapy, or if it came back after initial hormone therapy for advanced disease. If your cancer was advanced from the start and has since progressed after initial hormone therapy, you might also be eligible. Importantly, you shouldn't have had more than one line of hormone therapy or any chemotherapy for advanced breast cancer before joining the study.

Finally, you must be postmenopausal, either naturally, through surgery, or by using medication to stop your ovaries working. If you can still get pregnant, you'll need to have a negative pregnancy test and agree to use effective birth control during and for a period after the study.

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 with breast cancer that is hormone receptor positive and HER2 negative?
Is your breast cancer considered advanced (spread locally or to other parts of the body) and not suitable for curative surgery?
Has your cancer come back or gotten worse after receiving earlier hormone therapy for advanced disease, and you haven't had more than one type of hormone therapy or any chemotherapy for advanced cancer?
Are you postmenopausal due to natural causes, surgery, or medication?
If you can still get pregnant, are you able and willing to use effective birth control?

Answer every question to see your result.

What does participation involve?

Taking part in this study means you will receive regular medical care and study treatments according to a planned schedule. You'll have regular appointments at the study clinic for check-ups, blood tests, and scans to monitor your health and how the treatment is working. Depending on which group you're in, you'll either receive abemaciclib plus fulvestrant, or fulvestrant plus a placebo (a dummy drug).

For most participants, you'll be randomly assigned to one of these groups, like flipping a coin, but with a higher chance of getting the active combination. If you're in the group for those who haven't had hormone therapy for advanced breast cancer before, you'll receive the abemaciclib and fulvestrant combination. The study drugs will be given according to a specific schedule, and you'll be monitored closely for any side effects.

The total time you'll be actively involved in the study treatment and assessments is expected to be around nine months. After this period, you will continue to be followed up by the research team to track your long-term health and any ongoing effects of the treatment, even if you stop taking the study medication. You'll receive detailed information about what is expected at each visit before you decide to join.

Potential risks and benefits

Joining a clinical trial might offer potential benefits, such as receiving a new and promising treatment before it's widely available, and getting very close medical attention from a specialist team. While abemaciclib has shown promise, it's not guaranteed to work for everyone, and it might not be better than standard treatments. There are potential risks, as any medication can cause side effects. These will be fully explained to you before you decide to participate, 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 (146)

St. Bernards Medical Center
Verified postcode
Jonesboro, United States
Highlands Oncology Group
Verified postcode
Springdale, United States
University of California - San Diego
Verified postcode
La Jolla, United States
Kaiser Permanente
Verified postcode
Riverside, United States
Univ of California San Francisco
Verified postcode
San Francisco, United States
Stanford University Clinic
Verified postcode
Stanford, United States
Palm Beach Cancer Institue
Verified postcode
Atlantis, United States
Holy Cross Hospital
Verified postcode
Fort Lauderdale, United States
Florida Cancer Specialists - South
Verified postcode
Fort Myers, United States
Palm Beach Cancer Institue
Verified postcode
Palm Beach Gardens, United States
Florida Cancer Specialists - North
Verified postcode
St. Petersburg, United States
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Verified postcode
Tampa, United States

Common questions

What is 'hormone receptor positive' breast cancer?

This means your breast cancer cells have special proteins (receptors) that attach to hormones like oestrogen. These hormones can make the cancer grow, so treatments often aim to block this effect.

What does 'HER2 negative' mean?

HER2 is another protein that can be found on breast cancer cells. 'HER2 negative' means your cancer doesn't have high levels of this particular protein, which helps doctors choose the right treatments for you.

What is the difference between abemaciclib and fulvestrant?

Fulvestrant is a hormone therapy that blocks oestrogen from reaching cancer cells. Abemaciclib is a newer type of drug that works by stopping cancer cells from dividing and growing as quickly.

Will I definitely get the new drug combination?

For most participants, there's a two-thirds chance you'll get abemaciclib plus fulvestrant, and a one-third chance you'll get fulvestrant plus a dummy pill (placebo). However, if you haven't had hormone therapy for advanced cancer before, you'll receive the abemaciclib plus fulvestrant combination.

How long will I be in the study?

You'll be actively involved with treatment and assessments for about nine months, but the research team will continue to follow your health for a longer period after that.