Study Comparing Abemaciclib and Fulvestrant with Placebo and Fulvestrant for Patients with Advanced or Metastatic Breast Cancer After Previous Treatment

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What is this study about?

This clinical trial is focused on studying a type of breast cancer known as HR-positive, HER2-negative advanced or metastatic breast cancer. This type of cancer is characterized by the presence of hormone receptors (HR) and the absence of a protein called HER2. The study is designed to evaluate the effectiveness of a treatment combination involving two medications: abemaciclib and fulvestrant. Abemaciclib is a medication that works by inhibiting certain proteins involved in cancer cell growth, while fulvestrant is a hormone therapy that blocks the effects of estrogen on cancer cells. The trial will compare the effects of using both abemaciclib and fulvestrant together against using a placebo with fulvestrant.

The purpose of the study is to determine how well the combination of abemaciclib and fulvestrant works in treating patients who have already been treated with a type of medication called a CDK4/6 inhibitor and hormone therapy. Participants in the study will be randomly assigned to receive either the combination of abemaciclib and fulvestrant or a placebo with fulvestrant. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the actual medication or the placebo, which is known as a double-blind study.

Throughout the study, participants will receive regular check-ups and monitoring to assess the progression of their cancer and any side effects from the treatment. The study aims to provide valuable information on whether the combination of abemaciclib and fulvestrant can help improve outcomes for patients with this specific type of breast cancer. The trial is expected to continue for a period of time to gather sufficient data on the treatment’s effectiveness and safety.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, such as having a diagnosis of HR+, HER2- advanced or metastatic breast cancer and evidence of disease progression.

Participants must be able to swallow tablets and have adequate organ function.

2 treatment initiation

The treatment involves the administration of two medications: abemaciclib and fulvestrant.

Abemaciclib is provided in the form of 50 mg film-coated tablets and is taken orally.

Fulvestrant is administered through an intramuscular injection.

3 treatment schedule

The treatment is conducted in cycles, with specific dosages and frequencies determined by the study protocol.

Participants receive fulvestrant injections on a regular schedule, while abemaciclib tablets are taken daily.

4 monitoring and assessments

Throughout the study, regular monitoring and assessments are conducted to evaluate the response to treatment.

Progression-Free Survival (PFS) is the primary endpoint, meaning the time during which the disease does not worsen is measured.

5 completion of the study

The study is estimated to conclude by February 16, 2026.

Upon completion, final assessments are conducted to determine the overall efficacy of the treatment.

Who Can Join the Study?

Have a diagnosis of HR+ (hormone receptor-positive), HER2- (human epidermal growth factor receptor 2-negative) locally advanced or metastatic breast cancer.
Have radiologic evidence (imaging tests) showing that the disease has gotten worse or come back. This should be either while on treatment with a CDK4/6 inhibitor (a type of cancer treatment) with an aromatase inhibitor (AI) as the first treatment for advanced disease, or on/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET) given as additional treatment for early-stage breast cancer.
Must be considered suitable for treatment with endocrine therapy (ET), which is a treatment that blocks or removes hormones that fuel certain cancers.
If female, must be in a postmenopausal status, which means having gone through menopause naturally, through surgery, or by using medication to stop the ovaries from working.
Have Response Evaluable Criteria in Solid Tumors (RECIST) evaluable disease, meaning the disease can be measured or assessed through medical imaging.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale, which is a way to measure how well a person can perform daily activities. A score of 0 means fully active, and 1 means restricted in physically strenuous activity but able to do light work.
Have adequate renal (kidney), hematologic (blood), and hepatic (liver) organ function, meaning these organs are working well enough.
Must be able to swallow capsules or tablets.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have not reached the required age range for the study.
Patients who are not able to follow the study procedures or instructions.
Patients who have a medical condition that could interfere with the study treatment.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have had a recent surgery or medical procedure that could affect the study.
Patients who have a history of allergic reactions to the study medications.
Patients who have a serious infection or illness that could affect their participation.
Patients who have a history of drug or alcohol abuse.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Central Hospital Of Northern Pest Military Hospital	Budapest	Hungary
Centre Hospitalier Departemental Vendee	La Roche sur Yon	France
Orszagos Onkologiai Intezet	Budapest	Hungary
Algemeen Ziekenhuis Klina	Brasschaat	Belgium
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Humanitas Istituto Clinico Catanese S.p.A.	Misterbianco	Italy
University General Hospital Of Heraklion	Heraklion	Greece
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Azienda USL Toscana Sud Est	Arezzo	Italy
Azienda Sanitaria Locale Viterbo	Viterbo	Italy
Hospital Universitario De Toledo Ute	Toledo	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
Alexandra Hospital	Athens	Greece
Hospital Clinic De Barcelona	Barcelona	Spain
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Jessa Ziekenhuis	Hasselt	Belgium
General University Hospital Of Patras	Patras	Greece
Salut Sant Joan De Reus	Reus	Spain
Region Midtjylland	Aarhus	Denmark
Servei De Salut De Les Illes Balears	Palma	Spain
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej	Opole	Poland
L’Hopital Prive Du Confluent	Nantes	France
Hecddvht Uktecshqgptpl Dq Bnbnmpw	Badajoz	Spain
Hypyddba Ugkcizcclfppm Rgmkntsg Dr Mogwqt	Malaga	Spain
Mryrykocw strrpl	Horovice	Czechia
Bwzpkywtvxg Vbyfnldyk Otpzamybdbgm	Kecskemet	Hungary
Ixyppdvu Bfeelayn	Bordeaux	France
Htmgua Humnajaa	Herlev	Denmark
Igrffeca Rrdhevfaj Pmd Lx Srqxwf Duv Tlkyud Dohj Apmfavz Ibpr Shclur	Meldola	Italy
Gbicveyzjdwcpvtos Voeztrnlv Ptfj Axikfb Ekxzolhy Oyzssk Kuoklh	Gyor	Hungary
Ayurmz Mfhmusl Csvlzj Sksm	Thessaloniki	Greece
Hfoatmtl Uaqdtgxuzcfnq da A Cadhbx	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	11.03.2022
Czechia	Not recruiting	11.03.2022
Denmark	Not recruiting	11.03.2022
France	Not recruiting	11.03.2022
Greece	Not recruiting	11.03.2022
Hungary	Not recruiting	11.03.2022
Italy	Not recruiting	11.03.2022
Poland	Not recruiting	11.03.2022
Spain	Not recruiting	11.03.2022

Trial locations

Investigated drugs:

Abemaciclib is a medication used in this trial to treat advanced or metastatic breast cancer. It works by blocking certain proteins called CDK4 and CDK6, which are involved in the growth and division of cancer cells. By inhibiting these proteins, abemaciclib can help slow down or stop the progression of cancer.

Fulvestrant is another medication used in this trial for treating advanced or metastatic breast cancer. It is a type of hormone therapy that works by blocking and degrading estrogen receptors on cancer cells. Since some breast cancers need estrogen to grow, fulvestrant can help slow down or stop the growth of these cancer cells.

Investigated diseases:

Breast neoplasm

Breast Neoplasm – This is a condition where abnormal cells in the breast grow uncontrollably, forming a mass or lump known as a tumor. It can start in different parts of the breast, such as the ducts or lobules. As the disease progresses, the tumor may grow larger and can potentially spread to nearby tissues or lymph nodes. The growth rate and behavior of the tumor can vary, with some being slow-growing and others more aggressive. Over time, if not managed, it may lead to changes in the shape or size of the breast and can cause symptoms like lumps, pain, or discharge.

Neoplasm Metastasis – This refers to the process by which cancer cells spread from the original tumor site to other parts of the body. It occurs when cancer cells break away from the primary tumor and travel through the bloodstream or lymphatic system. These cells can form new tumors in other organs or tissues, which are known as metastatic tumors. The progression of metastasis can vary, with some cancers spreading quickly and others more slowly. This process can lead to the involvement of multiple organs, affecting their function and potentially leading to a range of symptoms depending on the organs affected.

Trial ID:

2023-506771-10-00

Protocol code:

I3Y-MC-JPEF

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Abemaciclib and Fulvestrant with Placebo and Fulvestrant for Patients with Advanced or Metastatic Breast Cancer After Previous Treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?