Study on Optimizing CDK 4/6 Inhibitors and Endocrine Therapy for Older Patients with Advanced Breast Cancer Using Abemaciclib, Palbociclib, and Ribociclib

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What is this study about?

This clinical trial is focused on studying treatments for Advanced Breast Cancer in older patients. The study involves several medications, including Verzenios (abemaciclib), Faslodex (fulvestrant), IBRANCE (palbociclib), Arimidex (anastrozole), Kisqali (ribociclib), Aromasin (exemestane), and Femara (letrozole). These medications are used to explore the effectiveness of different doses of CDK 4/6-inhibitors, which are a type of cancer treatment that helps to slow down the growth of cancer cells. The purpose of the study is to investigate how well these treatments work when given at a lower initial dose along with endocrine therapy, compared to the full recommended dose, in older patients who may be more vulnerable or frail.

Participants in the study will receive either the lower dose or the full dose of the CDK 4/6-inhibitors along with endocrine therapy. The study will monitor the time it takes for the treatment to stop being effective, known as “time to treatment failure.” Other aspects being observed include overall survival, progression-free survival, and the time it takes before chemotherapy is needed. The study will also look at the side effects of the treatments, the quality of life of the participants, and the cost-effectiveness of the treatments.

The trial is expected to run until 2031, with recruitment starting in November 2023. This study aims to provide valuable insights into optimizing treatment for older patients with advanced breast cancer, ensuring they receive the most effective and safe care possible.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. Consent is required before any study-specific activities begin.

2 initial assessment

A comprehensive assessment will be conducted to evaluate the patient’s health status. This includes a geriatric assessment to determine the appropriate dosage of medications.

3 medication administration

The patient will receive a combination of CDK 4/6-inhibitors and endocrine therapy. The specific medications include abemaciclib, palbociclib, and ribociclib, administered orally in tablet form.

The dosage and frequency will be adjusted based on the initial assessment. The treatment aims to manage advanced breast cancer in older patients.

4 ongoing monitoring

Regular monitoring will be conducted to assess the patient’s response to treatment. This includes evaluating the time to treatment failure and other health indicators.

Adjustments to the treatment plan may be made based on the patient’s progress and any side effects experienced.

5 end of treatment

The study will continue until the estimated end date in May 2031, or until the patient completes the treatment protocol.

Final assessments will be conducted to evaluate the overall effectiveness and impact of the treatment on the patient’s quality of life.

Who Can Join the Study?

Patients must be at least 70 years old. Male patients should use effective birth control methods during and for at least 14 weeks after therapy.
Patients must be able to understand and give consent in English or their native language.
Patients must have a confirmed diagnosis of HR-positive (estrogen-receptor 1% or more) and HER2-negative breast cancer, based on the most recent tumor test.
Patients must have advanced breast cancer that cannot be cured with current treatments.
Patients should not have had any previous systemic treatment for advanced breast cancer. However, if the cancer returned during previous hormone therapy, they can still participate. A short treatment with certain hormone therapies before starting the study treatment is allowed.
Patients who had previous treatment with CDK4/6-inhibitors can participate if they have been free of the disease for more than 12 months after stopping the treatment.
Patients must have either measurable disease or bone-only disease that can be evaluated according to specific criteria.
Patients must provide written consent before any study-related procedures begin.
Patients must have adequate organ function, which includes specific blood counts and liver and kidney function levels. An ECG test is required to check heart function before starting treatment with ribociclib.
Patients must be able to swallow capsules.

Who Cannot Join the Study?

Patients who do not have advanced breast cancer. Advanced breast cancer means the cancer has spread beyond the breast to other parts of the body.
Patients who are not considered older. This study is focused on older patients.
Patients who are not vulnerable or frail. Vulnerable or frail means patients who may have additional health challenges or are weaker.
Patients who cannot take CDK 4/6-inhibitors. These are medications used to treat certain types of breast cancer.
Patients who cannot undergo endocrine therapy. Endocrine therapy is a treatment that blocks or removes hormones that fuel some cancers.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliero Universitaria Careggi	Florence	Italy

Other Sites

Site Name	City	Country
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A.	Athens	Greece
General University Hospital Of Patras	Patras	Greece
Azienda USL Toscana Centro	Prato	Italy
St. Luke’s Hospital S.A.	Thessaloniki	Greece
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Region Oerebro Laen	Orebro	Sweden
Metropolitan Hospital	Athens	Greece
Aybagfgw Uuaniaojpr Hiwaonrd	Lorenskog	Norway
Sq Ajvqyql Hadcvhqx	Patras	Greece
Hijqai Hinxrwmz	Athens	Greece
Tepkhjqcek Czeacc Hqjxgixk	Thessaloniki	Greece
Uwcsqer Uyxtohzgex Hkazsgcc	Uppsala	Sweden
Hrkbhdsf Uqnpfdxkim Copusht Hppzwrnl	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Finland	Recruiting	15.11.2023
Greece	Recruiting	15.11.2023
Italy	Recruiting	15.11.2023
Norway	Recruiting	15.11.2023
Spain	Recruiting	15.11.2023
Sweden	Recruiting	15.11.2023

Trial locations

Investigated drugs:

CDK 4/6-inhibitors are a type of medication used to treat certain types of breast cancer. They work by blocking specific proteins in cancer cells, which helps to stop the cells from growing and dividing. In this trial, these inhibitors are being tested to see if starting with a lower dose is effective for older patients who are more vulnerable or frail.

Endocrine therapy is a treatment that adds, blocks, or removes hormones. For certain types of breast cancer that are sensitive to hormones, this therapy can help slow or stop the growth of cancer by interfering with the body’s hormone production or action. In this trial, endocrine therapy is used in combination with CDK 4/6-inhibitors to see how well they work together in treating older breast cancer patients.

Investigated diseases:

Breast cancer

Advanced Breast Cancer – This is a stage of breast cancer where the disease has spread beyond the breast and nearby lymph nodes to other parts of the body. It is often referred to as metastatic breast cancer. The progression of the disease can vary, with cancer cells potentially affecting organs such as the bones, liver, lungs, or brain. Symptoms may include persistent pain, fatigue, and changes in appetite or weight. The disease can progress at different rates, and its impact on daily life can vary significantly among individuals. Management focuses on controlling the spread and alleviating symptoms to improve quality of life.

Trial ID:

2023-506620-87-00

Protocol code:

IMPORTANT TRIAL

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Optimizing CDK 4/6 Inhibitors and Endocrine Therapy for Older Patients with Advanced Breast Cancer Using Abemaciclib, Palbociclib, and Ribociclib

What is this study about?

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