Active not recruitingPHASE2INTERVENTIONAL

A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer

This study is exploring new treatment options for women with breast cancer that has spread and has specific characteristics (called hormone receptor-positive, HER2-negative). Participants will either receive a drug called abemaciclib along with tamoxifen, or abemaciclib by itself. The main goal is to find out if these treatments are safe and work well for patients who have already tried other therapies for their cancer. We want to understand if these combinations can help control the cancer and improve patient well-being. This is a Phase 2 study, meaning it's still in the earlier stages, focusing on how well the drugs work and any side effects.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Eli Lilly and Company

Enrolment target

234

Start

14 Sep 2016

Estimated completion

01 Dec 2026

Metastatic Breast Cancer

Results

Results from this study

Posted July 2019

Results have been published for this study.

Primary outcome

Progression Free Survival (PFS)

Progression-free survival time was measured from the date of randomization to the date of investigator-determined objective progression as defined by RECIST v1.1, or death from any cause, whichever occurred first. Progressive disease (PD) is defined as 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. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment (if available) or date of randomization if no post baseline radiographic assessment is available.

Full results on the registry

What is this study about?

This research study is looking into new ways to treat a specific type of breast cancer. This type is called 'hormone receptor-positive, HER2-negative,' which means the cancer cells are affected by hormones but don't have a high level of a certain protein called HER2. This study is for women whose breast cancer has spread to other parts of the body (this is called metastatic breast cancer) and who have already undergone some treatments that haven't fully stopped the cancer.

The study wants to see how well a drug called abemaciclib works, either on its own or when combined with another common breast cancer drug called tamoxifen. Doctors call these 'interventions.' The main things we want to learn are if these treatments are safe for patients and if they help to control the cancer. This is important because finding more effective and safer treatments for advanced breast cancer is a key goal in cancer care.

By taking part, individuals contribute to medical knowledge that could lead to better treatments for future patients with similar conditions. It's a way for doctors to carefully test new medicines and combinations to see if they are better than existing options. This study is in an earlier stage of testing, called Phase 2, which generally focuses on how well the treatments work and what side effects they might cause in a smaller group of people.

Key takeaways

This study is testing new treatments for advanced breast cancer.
It's for women whose breast cancer has spread and has specific characteristics.
Participants will receive abemaciclib with tamoxifen, or abemaciclib alone.
The main goals are to check treatment safety and how well it controls cancer.
Regular health checks and scans will be part of participation.
You can stop participating at any time.

Who may be eligible?

To join this study, you would typically be a woman aged 18 or older with breast cancer that has spread and has specific features (hormone receptor-positive and HER2-negative). You would have already received some previous treatments for your cancer, including at least one but no more than two chemotherapy treatments for the advanced stage. Your cancer must also be measurable, meaning doctors can track its size.

Your overall health needs to be good enough to take part, and your body's organs like kidneys and liver need to be working properly. You shouldn't have specific heart problems or ongoing serious infections that require strong antibiotics. If you are able to become pregnant, you would need to have a negative pregnancy test and agree to use effective birth control during and for a few weeks after the study.

There are also some reasons why you might not be able to join. For example, if your cancer has spread to your brain or spinal cord, or if you've already had a similar type of drug to abemaciclib. You also can't have a chronic condition that causes persistent diarrhoea, or a history of certain other cancers (unless it's a very specific type like non-melanoma skin cancer or certain early-stage cervical or breast cancers).

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.

Do I have breast cancer that has spread?
Is my breast cancer hormone receptor-positive and HER2-negative?
Have I already had other treatments for my cancer, including at least one but no more than two chemotherapies for the advanced stage?
Do I have cancer that doctors can measure and track?
Am I generally well enough to take part and am I over 18?
Do I have good organ function (e.g., kidneys, liver performing well)?

Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, you will receive either abemaciclib along with tamoxifen, or abemaciclib on its own. You will also receive a medication called prophylactic loperamide, which is given to prevent diarrhoea. You would take the study medication by mouth.

Participation will involve regular visits to the clinic 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 track any side effects and see if the treatment is working. You would need to stop any previous cancer treatments for at least three weeks (for stronger medicines) or two weeks (for milder ones) before starting the study drugs, and make sure any side effects from those treatments have mostly cleared up. The total duration of your participation would depend on how your cancer responds to the treatment and until the study doctors decide it's appropriate to stop the study treatment, with follow-up appointments continuing afterwards.

Potential risks and benefits

Like all medical treatments, taking part in this study could offer potential benefits and potential risks. The potential benefit is that these new treatment combinations might help control your cancer more effectively than existing options, or lead to a better quality of life. However, there's no guarantee the treatment will work for you, and there could be side effects. The study aims to carefully identify these. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (59)

The University of Arizona Cancer Center
Verified postcode
Tucson, United States
Dartmouth Hitchcock Medical Center
Verified postcode
Lebanon, United States
Tennessee Oncology PLLC
Verified postcode
Nashville, United States
The Center for Cancer and Blood Disorders
Verified postcode
Fort Worth, United States
University of Wisconsin Clinical Research Center
Verified postcode
Madison, United States
CENIT Centro de Neurociencias, Investigación y Tratamiento
City only
CABA, Argentina
Fundacion Ars Medica
Verified postcode
San Salvador de Jujuy, Argentina
Clinica Viedma
Verified postcode
Viedma, Argentina
Instituto de Oncología de Rosario
Verified postcode
Rosario, Argentina
Centro Para la Atención Integral del Paciente Oncologico (CAIPO)
Verified postcode
San Miguel de Tucumán, Argentina
Sanatorio Parque
Verified postcode
Salta, Argentina
Medizinische Universitaet Graz
Verified postcode
Graz, Austria

Common questions

What is 'metastatic breast cancer'?

Metastatic breast cancer means the cancer has spread from the breast to other parts of your body.

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

This describes specific features of your cancer cells. 'Hormone receptor-positive' means the cancer uses hormones to grow, and 'HER2-negative' means it doesn't have a high level of a protein called HER2.

What is abemaciclib?

Abemaciclib is a type of medicine designed to target cancer cells and stop them from growing.

Why is this study only for women?

This particular study focuses on breast cancer in women because the specific type of cancer being studied is more common in women.

What is a Phase 2 study?

A Phase 2 study is an early stage of clinical research. It mainly checks if a new treatment is effective and safe in a slightly larger group of people than Phase 1 studies.