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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Gemeinschaftspraxis Dr. Pourfard & Dr. Uleer	Hildesheim	Germany
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
Technische Universitaet Dresden	Dresden	Germany
Klinikverbund Suedwest GmbH	Böblingen	Germany

Other Sites

Site Name	City	Country
Haematologie-Onkologie im Zentrum MVZ GmbH	Augsburg	Germany
Vivantes Netzwerk fuer Gesundheit GmbH	Berlin	Germany
Champalimaud Clinical Centre	Lisbon	Portugal
Rotkreuzklinikum Muenchen gGmbH	Munich	Germany
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Ludwig Maximilian University Of Munich	Munich	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
St. Vincenz-Krankenhaus GmbH	Paderborn	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Evangelisches Krankenhaus Bergisch Gladbach gGmbH	Bergisch Gladbach	Germany
Marienhospital Bottrop gGmbH	Bottrop	Germany
HELIOS Klinikum Berlin-Buch GmbH	Berlin	Germany
Staedtisches Klinikum Dessau	Dessau-Roßlau	Germany
Hospital De Santa Maria E.P.E.	Lisbon	Portugal
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.	Coimbra	Portugal
Studienzentrum Onkologie Ravensburg GmbH	Ravensburg	Germany
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH	Moenchengladbach	Germany
MVZ-Onkologie Velbert GbR	Velbert	Germany
MVZ Nordoberpfalz GmbH	Weiden I.D.Opf.	Germany
Marienhaus Klinikum Mainz GmbH	Mainz	Germany
St. Elisabeth-Krankenhaus Leipzig	Leipzig	Germany
Gemeinschaftspraxis Für Hämatologie And Onkologie	Langen	Germany
Hospital CUF Porto S.A.	Porto	Portugal
Lizhnvqg Obpoxtygmbyz Sdwodrehecespotdh	Luebeck	Germany
Odgwfaxudqmo Sorqrthnvreiiuqyw	Bielefeld	Germany
Uaihynrqcsrwuksgldbow Ddleskiculm Aae	Duesseldorf	Germany
Uxlfitylac Mjyagme Cvasdb Hvhswnlstoocndjau	Hamburg	Germany
Ugaqztjjfowpjajiewmjp Edmzl Ani	Essen	Germany
Uvtgohprwfdtyzhgrwprh Avloddhr	Augsburg	Germany
Kgcaqfif Esvdhgpjjjxdrbgoobkroagw Haenrblprktxjwilr	Essen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	30.07.2025
Portugal	Recruiting	30.07.2025

Trial locations

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.

Investigated diseases:

Hormone receptor positive HER2 negative breast cancer

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.

Trial ID:

2022-503001-38-01

Protocol code:

CLEE011O12001

NCT ID:

NCT05827081

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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