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 Status
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
Hxhcbovr Ulqfcpbszxlrs Dx Budmnya Badajoz Spain
Hawyhnfc Utvltjnzaxabc Rtxmsqvc Dq Mftccv Malaga Spain
Mmxwswsya siqost Horovice Czechia
Bvhkswuifwt Vyrlmhlit Onwkojgtfyag Kecskemet Hungary
Iqortyso Bcqwdtoy Bordeaux France
Hypbmd Hqrtlhos Herlev Denmark
Ilovmtmw Rkwolcnpj Pvg Le Scwyls Dkn Tylugb Dnka Azxjfaw Iczw Sdqvit Meldola Italy
Gjdhtfqfnaqticfaz Vjwrnsdrm Pcyv Aocpft Ehjvajrh Ovjugu Kwmtvv Gyor Hungary
Amyoho Mhxtbod Cmffmg Sgzi Thessaloniki Greece
Hxtfwine Umiaxfyxxdjzb de A Cfeflr A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

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