Active not recruitingPHASE3INTERVENTIONAL

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

This study is investigating a new way to treat early-stage breast cancer that is hormone receptor-positive and HER2-negative. Doctors want to see if adding a drug called ribociclib to standard hormone therapy helps prevent the cancer from returning. Patients will either receive ribociclib plus hormone therapy or hormone therapy alone. This research aims to understand if the combination treatment is more effective and safe. The study includes both women (before and after menopause) and men aged 18 and over who have undergone surgery for their breast cancer. It's a key step in finding better treatments for this type of breast cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Enrolment target

5,101

Start

07 Dec 2018

Estimated completion

29 May 2030

Early Breast Cancer

What is this study about?

This important study is looking into a type of breast cancer called 'early breast cancer' that is found to be hormone receptor-positive and HER2-negative. These are common characteristics of breast cancer that doctors test for. After surgery, and sometimes chemotherapy or radiotherapy, patients often receive hormone therapy to help stop the cancer from coming back. This study is exploring if adding a drug called ribociclib to this standard hormone therapy could be even more effective.

Imagine the study like comparing two paths forward after your initial cancer treatment. On one path, you receive the usual hormone therapy. On the other path, you receive the same hormone therapy but also take ribociclib. Doctors want to find out if the ribociclib path leads to better outcomes, meaning the cancer is less likely to return, and if the combined treatment is well-tolerated.

About 5,000 patients will take part, including women (both before and after menopause) and men. They will be split randomly into two groups, making sure the comparison is fair. This kind of research helps doctors understand the best ways to treat breast cancer in the future, aiming to offer patients the most effective and safest options possible.

Key takeaways

Investigates adding ribociclib to hormone therapy for early breast cancer.
Aims to see if the combination is more effective at preventing cancer recurrence.
Includes women (pre/post-menopausal) and men with HR+/HER2- early breast cancer.
Patients are randomly assigned to receive either combo or hormone therapy alone.
Treatment duration for hormone therapy is five years; ribociclib is for three years.
Important for finding better future treatments for this type of breast cancer.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old and have been diagnosed with early breast cancer that is hormone receptor-positive and HER2-negative. This diagnosis must have been made within the last 18 months.

You should have already had surgery for your breast cancer. Depending on your situation, you might have also received radiotherapy or chemotherapy. The doctors also need to believe that standard hormone therapy would be a suitable long-term treatment for you.

The study includes women, both before and after menopause, and men. For women, your menopausal status would be carefully checked based on your age, whether you've had certain surgeries, or if you meet specific hormone level criteria.

Quick self-check

Are you 18 years old or older?
Do you have early breast cancer that is hormone receptor-positive and HER2-negative?
Have you had surgery for your breast cancer within the last 18 months?
Are you considered suitable for ongoing hormone therapy?
Are you a woman (pre- or post-menopausal) or a man?

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 be randomly assigned to one of two groups. One group will take the drug ribociclib every day for three weeks, followed by one week off, for about three years. This group will also take standard hormone therapy every day for five years. The other group will take only the standard hormone therapy every day for five years.

You'll have regular appointments to monitor your health, check for any side effects, and see how the treatment is working. The hormone therapy would be taken for a total of 60 months (five years) from the start of the study. After this, your own doctor would decide on any further treatment. The overall duration of your active involvement in the study's treatment will depend on which group you are in, but the hormone therapy component for both groups lasts for five years.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new treatment (ribociclib) that might prove more effective than standard hormone therapy alone in preventing your cancer from returning. However, it's also important to be aware of potential risks, including side effects from the investigational drug. All medical treatments have potential side effects, and these would be carefully explained and monitored if you were to participate. You would also contribute to valuable medical research that could help future patients. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (387)

University of Alabama at Birmingham-Kirklin Clinic
Birmingham, United States
Cancer Treatment Centers of America
Goodyear, United States
St Bernards Medical Center
Jonesboro, United States
Comprehensive Blood and Cancer
Bakersfield, United States
UCLA Beverly Hills
Beverly Hills, United States
UCLA Burbank
Burbank, United States
Encino Research Center
Encino, United States
St. Jude Heritage Medical Group
Fullerton, United States
UCLA Hematology Oncology
Laguna Hills, United States
Southern CA Oncology Rsrch Alliance
Los Angeles, United States
Stanford University Medical Center
Palo Alto, United States
UCLA Pasadena HC Hemato Onco
Pasadena, United States

+375 more sites — see the official record for the full list.

Common questions

What is 'Hormone Receptor-positive' breast cancer?

It means the cancer cells have receptors that can attach to hormones like oestrogen. Hormone therapy works by blocking these hormones or their receptors to stop the cancer from growing.

What does 'HER2-negative' mean?

This means the cancer cells do not have high levels of a protein called HER2. This is important because some specific drugs target HER2-positive cancers, but this study is for HER2-negative ones.

What is ribociclib?

Ribociclib is a type of drug that targets specific proteins involved in cancer cell growth. It's often used with hormone therapy to improve treatment outcomes.

Why is the study 'randomised'?

Randomisation means patients are put into groups by chance. This helps make sure the groups are similar, so doctors can fairly compare the effects of the different treatments.

How long will I take the study treatment?

If you get ribociclib, you'll take it for about three years. The hormone therapy in both groups will be taken for five years.