Long-term safety study of ribociclib with letrozole, tamoxifen, or goserelin acetate in patients with HR-positive, HER2-negative advanced or metastatic breast cancer

3 1 1 1

What is this study about?

This clinical trial focuses on patients with HR-positive, HER2-negative advanced or metastatic breast cancer. The study evaluates the long-term safety of ribociclib (also known as LEE011) when used in combination with other medications. The other medications that may be used in combination with ribociclib include tamoxifen, letrozole, and goserelin acetate.

The purpose of this study is to provide continued access to ribociclib treatment for patients who have been receiving this medication in previous Novartis-sponsored studies and have shown benefit from the treatment. The study will monitor how well patients tolerate the treatment over an extended period and track any side effects that may occur.

During the study, patients will continue their current treatment combination that includes ribociclib. The medications are given by mouth as tablets or capsules, except for goserelin acetate which is given as an implant. Patients will have regular check-ups to monitor their health and any potential side effects throughout their participation in the study.

1 Initial treatment phase

You will receive a combination of medications including ribociclib (oral capsules) along with other prescribed treatments.

Your treatment includes a combination of oral medications: tamoxifen, letrozole, and ribociclib. Some patients may also receive goserelin acetate through implantation.

The treatment continues as long as you show clinical benefit from the therapy.

2 Regular medical assessments

Your doctor will conduct regular evaluations to monitor your response to the treatment.

These assessments include checking for any side effects or adverse reactions to the medications.

The medical team will evaluate the clinical benefit of the treatment during each visit.

3 Safety monitoring

Regular monitoring of any side effects or unexpected reactions to the treatment will be performed.

The medical team will track and document any adverse events throughout your participation.

Your safety and well-being will be continuously evaluated during the entire treatment period.

4 Long-term treatment continuation

The treatment may continue until 2030, depending on your individual response and clinical benefit.

Regular scheduled visits will be required throughout the treatment period.

Your doctor will determine if continuing the treatment is beneficial for your condition.

Who Can Join the Study?

You must be currently taking part in a parent study sponsored by Novartis where you are receiving ribociclib (a medication used to treat breast cancer) combined with other medications
You must be willing and able to follow the study schedule, including:
– Attending all planned visits
– Following treatment plans
– Completing all required study procedures
You must have been taking ribociclib for at least 6 treatment cycles in the parent study (a cycle typically lasts 28 days)
Your doctor must determine that you are receiving benefit from the treatment
You must have HR-positive, HER2-negative advanced or metastatic breast cancer (breast cancer that has spread and has specific characteristics that make it responsive to hormonal therapy but not to HER2-targeted treatments)
You can be either male or female
You must be an adult (18 years or older)

Who Cannot Join the Study?

History of severe allergic reactions to any of the study medications
Active brain metastases (cancer that has spread to the brain) that are not stable
Impaired heart function, including heart failure or significant heart rhythm problems
Severe liver dysfunction (problems with liver function)
Severe kidney dysfunction (problems with kidney function)
Current treatment with other investigational drugs (medications being tested in other clinical trials)
Pregnant or breastfeeding women
Unable to swallow oral medications
History of other cancers within the past 5 years, except for adequately treated non-melanoma skin cancer or cervical cancer in situ
Any medical condition that the study doctor believes would make participation unsafe
Known HIV infection (human immunodeficiency virus)
Active hepatitis B or C infection (viral infections affecting the liver)
Unable to comply with scheduled study visits and procedures

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Hospital Beatriz Angelo	Loures	Portugal
University General Hospital Of Heraklion	Heraklion	Greece
Champalimaud Clinical Centre	Lisbon	Portugal
Cmvcykcu Ssceudls Ifjdrhbs	L'hospitalet De Llobregat	Spain
Ikucwexn Rbkkxssef Pak Lj Sfdrdc Dgo Tahcrb Dckq Ayqgiie Ikee Sqggsp	Meldola	Italy
Ungsemtlhsdzwv Cmrwvfd Kigrvngir	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Greece	Not recruiting	07.07.2022
Italy	Not recruiting	07.07.2022
Poland	Not recruiting	07.07.2022
Portugal	Not recruiting	07.07.2022
Spain	Not recruiting	07.07.2022

Trial locations

Investigated drugs:

Ribociclib (LEE011) is a medication used in cancer treatment, specifically for treating certain types of breast cancer. It belongs to a class of drugs known as kinase inhibitors, which work by blocking specific proteins that promote cancer cell growth. This medication is typically used as part of a combination therapy regimen with other cancer treatments. It is taken orally and helps to slow down or stop the growth of cancer cells.

Investigated diseases:

Hormone Receptor-Positive, HER2-Negative Breast Cancer – A type of breast cancer characterized by the presence of hormone receptors (estrogen and/or progesterone) on cancer cells, while lacking excess HER2 protein. The cancer cells grow in response to natural hormones in the body. When the cancer spreads beyond the breast to distant parts of the body, it is called advanced or metastatic breast cancer. This form represents the most common type of breast cancer. The cancer can spread to various organs, including bones, liver, lungs, and brain, where it forms new tumors.

Trial ID:

2024-514891-41-00

Protocol code:

CLEE011A2412B

NCT ID:

NCT05161195

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Long-term safety study of ribociclib with letrozole, tamoxifen, or goserelin acetate in patients with HR-positive, HER2-negative advanced or metastatic breast cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?