Not recruiting

Study on the Effects of Ribociclib and Endocrine Therapy for Patients with HR-Positive, HER2-Negative Early Breast Cancer

Fast replyRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called ribociclib in combination with endocrine therapy for patients with a type of breast cancer known as HR-positive HER2-negative breast cancer. The purpose of the study is to learn more about how well this combination works and how safe it is for patients with early-stage breast cancer. The study will involve taking ribociclib along with other medications that are part of endocrine therapy, such as exemestane, goserelin, leuprorelin acetate, letrozole, and anastrozole. These medications are used to help block hormones that can promote the growth of cancer cells.

Participants in the study will receive treatment over a period of up to 36 months. The study will monitor the participants' health and the progression of their breast cancer during this time. The goal is to evaluate the rate of invasive breast cancer-free survival at three years for those taking ribociclib with endocrine therapy. This means the study will look at how many participants remain free from invasive breast cancer after three years of treatment. The study will also track any side effects or adverse events that participants may experience while taking the medication.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to gather information on the effectiveness of the treatment. The study aims to provide valuable insights into the potential benefits of using ribociclib in combination with endocrine therapy for treating early-stage HR-positive HER2-negative breast cancer. This research could help improve treatment options and outcomes for patients with this type of breast cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and consent
Upon joining the study, the first step involves an initial visit where the study details are explained. This includes the purpose of the study, the procedures involved, and the potential risks and benefits.
During this visit, consent is obtained. This means agreeing to participate in the study after understanding all the information provided.
Step 2
Screening and eligibility assessment
A series of tests and assessments are conducted to confirm eligibility for the study. This includes checking the diagnosis of HR-positive HER2-negative breast cancer and ensuring there are no contraindications to the treatment.
An ECG (electrocardiogram) is performed to assess heart function, ensuring the QTcF interval is less than 450 milliseconds and the heart rate is between 50-99 beats per minute.
Step 3
Treatment initiation
Once eligibility is confirmed, treatment begins. The treatment involves taking ribociclib orally, along with endocrine therapy (ET).
The specific medications used in the endocrine therapy may include exemestane, goserelin, leuprorelin acetate, letrozole, or anastrozole. The choice of medication depends on individual circumstances.
Step 4
Ongoing treatment and monitoring
The treatment continues over a period of time, with regular monitoring to assess the effectiveness and safety of the therapy.
Regular visits are scheduled to monitor health status, manage any side effects, and adjust treatment as necessary.
Step 5
Follow-up and evaluation
After completing the treatment phase, follow-up visits are conducted to evaluate the long-term effects of the treatment.
The primary goal is to assess invasive breast cancer free survival at three years, along with monitoring for any adverse events or changes in health status.

Who can join the trial?

9 criteria

Participant is an adult, male or female, who is at least 18 years old.
Participant has a confirmed diagnosis of breast cancer that is positive for estrogen or progesterone receptors. This means the cancer grows in response to these hormones.
Participant has breast cancer that is HER2-negative. This means the cancer does not have high levels of the HER2 protein.
Participant may have already received standard hormone therapy, such as tamoxifen or toremifene, but must enroll within 36 months of starting this therapy and have at least 3 years of therapy remaining.
Participant must not have any medical reasons that prevent them from receiving hormone therapy in the study.
Participant has had surgery to remove the tumor completely, with no cancer cells left at the edges of the removed tissue. The cancer must be in certain stages, specifically stage III or some parts of stage II.
Participant has an ECOG Performance Status of 0, 1, or 2. This is a scale used to assess how well a person can perform daily activities. A lower score means better functioning.
Participant has adequate bone marrow and organ function, meaning their blood and organs are working well enough to participate in the study.
Participant's heart function, measured by an ECG (a test that records the electrical activity of the heart), must meet specific criteria: a QTcF interval of less than 450 milliseconds and a resting heart rate between 50 and 99 beats per minute.

Who cannot join the trial?

4 criteria

Patients with a type of breast cancer that is not HR-positive or HER2-negative cannot participate. HR-positive means the cancer grows in response to hormones. HER2-negative means the cancer does not have high levels of a protein called HER2.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both females and males can participate, but certain conditions may exclude individuals.
Patients who are part of a vulnerable population may be excluded. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centro Hospitalar Universitario Sao Joao E.P.E.
Verified
Porto, Portugal
Kliniken Essen-Mitte,Evangelische Huyssens-Stiftung
Verified
Essen, Germany
Ludwig Maximilian University Of Munich
Responsive
Munich, Germany

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Ribociclib
is a medication used in this clinical trial to help treat early breast cancer that is hormone receptor-positive and HER2-negative. It works by blocking certain proteins in cancer cells, which can slow down or stop the growth of the cancer. This medication is often used in combination with other treatments to improve its effectiveness.
Endocrine Therapy
is a treatment used in this trial to help manage early breast cancer that is hormone receptor-positive. This type of therapy works by interfering with the body's hormone production or by blocking the effects of hormones on cancer cells. Since some breast cancers grow in response to hormones like estrogen, endocrine therapy can help slow down or stop the growth of these cancer cells.

What is already known about the treatment

Ribociclib – Ribociclib is taken orally in the form of tablets and is used in combination with endocrine therapy to treat a specific type of breast cancer known as HR-positive, HER2-negative early breast cancer. It is currently being studied in clinical trials to assess its effectiveness and safety in preventing the return of breast cancer after initial treatment. Ribociclib works by inhibiting certain proteins in cancer cells, which helps to slow down or stop their growth. It belongs to a class of drugs known as CDK4/6 inhibitors, which are designed to target and disrupt the cell cycle of cancer cells.

Investigated diseases

Hormone Receptor-Positive, HER2-Negative Breast Cancer – This type of breast cancer is characterized by the presence of hormone receptors, meaning the cancer cells grow in response to hormones like estrogen or progesterone. It lacks overexpression of the HER2 protein, which is another factor that can promote cancer growth. The disease typically begins in the breast tissue and can progress by spreading to nearby lymph nodes or other parts of the body. The growth of these cancer cells is often slower compared to other types of breast cancer. As the disease advances, it may lead to the formation of tumors in other organs. The progression can vary significantly among individuals, influenced by factors such as hormone levels and genetic predispositions.