Study Comparing Ribociclib and Palbociclib for Patients with Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

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What is this study about?

This clinical trial is focused on studying treatments for advanced hormone receptor-positive/HER2-negative/HER2-Enriched breast cancer. The study will compare two medications: ribociclib (also known as LEE011) and palbociclib, both of which are used in combination with endocrine therapy. The purpose of the study is to see which treatment is more effective in delaying the progression of the disease.

Participants in the study will receive either ribociclib or palbociclib, along with standard endocrine therapy. Ribociclib is taken as a film-coated tablet, while palbociclib is available in hard capsule form. The study will also include a group receiving a placebo. The trial will monitor the participants over a period to assess how well the treatments work in controlling the cancer and improving the quality of life for patients.

The study will involve regular visits to the clinic for treatment and monitoring. Participants will undergo various tests to track the progress of their condition and the effects of the treatment. The trial aims to provide valuable information on the safety and effectiveness of these medications in treating this specific type of breast cancer.

1 joining the study

Upon joining the study, the patient will be required to provide signed informed consent. This is necessary before any trial-specific procedures can begin.

A molecular pre-screening consent must also be signed prior to the PAM50 test, which is used to analyze the tumor subtype.

2 initial assessments

The patient will undergo various assessments to ensure eligibility, including blood tests to check hematologic and organ function.

A pregnancy test is required for women of childbearing potential, and effective contraception must be used during the trial.

3 treatment allocation

The patient will be randomly assigned to one of two treatment groups: ribociclib plus endocrine therapy or palbociclib plus endocrine therapy.

Both medications are used to treat advanced hormone receptor-positive, HER2-negative breast cancer.

4 medication administration

If assigned to the ribociclib group, the patient will take Kisqali 200 mg film-coated tablets orally.

If assigned to the palbociclib group, the patient will take IBRANCE hard capsules orally, with available dosages of 75 mg, 100 mg, or 125 mg.

5 additional treatments

Patients may also receive Tevimbra 100 mg concentrate for solution for infusion intravenously, depending on the specific treatment plan.

The frequency and duration of these treatments will be determined by the study protocol.

6 ongoing assessments

Throughout the trial, regular assessments will be conducted to monitor the patient’s health and response to treatment.

These assessments may include physical exams, blood tests, and imaging studies.

7 end of treatment

The trial is expected to continue until July 2028, with the duration of individual participation varying based on treatment response and other factors.

Upon completion of the trial, final assessments will be conducted to evaluate the patient’s condition.

Who Can Join the Study?

Patients must have advanced breast cancer that is hormone receptor-positive and HER2-negative.
Patients must sign an informed consent form before any trial-specific procedures begin.
Patients need to have adequate blood and organ function, as shown by specific lab tests.
Patients must be willing and able to follow the trial’s schedule, including visits, treatments, and tests.
Women who can become pregnant must have a negative pregnancy test before starting the trial.
Women who can become pregnant must agree to use highly effective birth control methods during the trial and for a period after stopping treatment.
Postmenopausal women or those who meet specific criteria can participate. Pre/perimenopausal women can join if they agree to additional treatment with specific medications.
Patients must be able to swallow pills.
Patients need to have a normal heart rhythm and heart rate as shown by an ECG test.
Men who are not sterile must use effective birth control during the study and for at least 120 days after the last dose of the study medication.
Participants must be at least 18 years old.
Patients must have breast cancer confirmed by specific tests showing it is hormone receptor-positive and HER2-negative.
Patients must have a good performance status, meaning they can carry out daily activities without significant limitations.
Previous radiation therapy for cancer that has spread is allowed if the patient has recovered from any side effects.
Patients must have advanced breast cancer that is not treatable with curative therapy or has spread to other parts of the body.
Patients must provide a tumor sample for specific testing to determine eligibility.
Patients must have a specific subtype of breast cancer as determined by a central test.
Patients must have measurable or evaluable disease according to specific criteria.

Who Cannot Join the Study?

Patients who do not have advanced hormone receptor-positive/HER2-negative/HER2-Enriched breast cancer. This means the cancer must be of a specific type that responds to hormones and is not related to a protein called HER2.
Patients who are not within the specified age range for the study. The study may have specific age requirements.
Patients who are not female or male, as the study includes both genders.
Patients who are considered part of a vulnerable population. This term refers to groups of people who might be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Jerez de la Frontera	Jerez De La Frontera	Spain

Other Sites

Site Name	City	Country
Hospital Universitari General De Catalunya	Sant Cugat Del Valles	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Hospital San Pedro De Alcantara	Caceres	Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Hospital Beatriz Angelo	Loures	Portugal
Hospital Universitario Basurto	Bilbao	Spain
Hospital Quironsalud Sagrado Corazon	Sevilla	Spain
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Unidade Local De Saude Do Alto Ave E.P.E.	Guimaraes	Portugal
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.	Lisbon	Portugal
Hospital Universitario De Leon	Leon	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Salut Sant Joan De Reus	Reus	Spain
Hospital Universitario De Canarias	La Laguna	Spain
Hvspfbri Urbpxnhmjavby Mlacpui Dm Vylbtbebnp	Santander	Spain
Idjevqsi Cwaihw Difytqtozkvpgdmct	L'hospitalet De Llobregat	Spain
Htlbrtkh Uzgfprndmnkwv Df Btlegmp	Badajoz	Spain
Hintpfsv Vmjn dbzbwlup	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Portugal	Not recruiting	01.03.2022
Spain	Not recruiting	01.03.2022

Trial locations

Investigated drugs:

Ribociclib is a medication used in this trial to treat advanced breast cancer that is hormone receptor-positive and HER2-negative. It works by inhibiting certain proteins in cancer cells, which can slow down or stop the growth of the cancer.

Palbociclib is another medication used in the trial for the same type of breast cancer. Like ribociclib, it targets specific proteins in cancer cells to help control the progression of the disease.

Endocrine Therapy is a treatment that involves using hormone-blocking medications to slow or stop the growth of hormone receptor-positive breast cancer. This therapy is used in combination with either ribociclib or palbociclib in the trial.

Investigated diseases:

Hormone receptor positive HER2 negative breast cancer

Advanced Hormone Receptor-Positive/HER2-Negative/HER2-Enriched 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 is negative for the human epidermal growth factor receptor 2 (HER2), which means it does not overexpress the HER2 protein. The HER2-enriched subtype is a specific category within this group, known for its unique gene expression profile. This cancer can progress by spreading to other parts of the body, often affecting bones, liver, lungs, or brain. The progression is typically monitored through imaging and clinical assessments to evaluate changes in tumor size and spread. The disease’s behavior can vary, with some cases showing slow progression while others may advance more rapidly.

Trial ID:

2023-508828-35-01

Protocol code:

SOLTI-2101

NCT ID:

NCT05207709

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Ribociclib and Palbociclib for Patients with Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?