Phase 1b-2 Study of Elacestrant and Abemaciclib in Patients with Brain Metastases from ER-Positive, HER2-Negative Breast Cancer

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What is this study about?

This clinical trial is focused on studying a type of breast cancer known as Estrogen Receptor Positive, HER-2 Negative Breast Cancer that has spread to the brain, referred to as brain metastasis. The study involves two medications: Elacestrant and Abemaciclib. Elacestrant is taken in the form of film-coated tablets, and Abemaciclib is also administered as film-coated tablets. The purpose of the study is to explore the effects of these medications when used together in patients with this specific type of breast cancer.

The study is divided into two phases. In the first phase, the focus is on determining the appropriate dose of Elacestrant when combined with Abemaciclib. In the second phase, the study aims to evaluate how effective this combination is in treating patients with brain metastases from this type of breast cancer. Participants will take the medications orally, and the study will monitor their response to the treatment over time.

Throughout the study, participants will be observed for any changes in their condition, including the size and number of brain metastases. The study will also track any side effects or adverse reactions to the medications. The goal is to gather information that could help improve treatment options for patients with this type of breast cancer in the future.

1 phase 1b evaluation

participation begins with the phase 1b stage of the study.

the goal of this stage is to find the recommended dose of elacestrant when used together with abemaciclib.

the medications, elacestrant and abemaciclib, are taken by mouth.

2 phase 2 evaluation

the second stage is the phase 2 evaluation.

the purpose of this stage is to check how well the combination of elacestrant and abemaciclib works for people with breast cancer that has spread to the brain.

the medications continue to be taken by mouth.

Who Can Join the Study?

You must sign a consent form, which is a document that explains all the details of the study before you begin any activities.
You must have had no more than one seizure (an uncontrolled electrical disturbance in the brain) in the 4 weeks before starting the study treatment.
You must have a life expectancy of at least 12 weeks.
You must have healthy bone marrow (the part of the body inside bones that makes blood cells) and organ function, based on specific blood tests for:
- Neutrophils (a type of white blood cell that fights infection).
- Platelets (cells that help blood clot).
- Hemoglobin (a protein in red blood cells that carries oxygen).
- Electrolytes (minerals like potassium, sodium, calcium, and magnesium that keep the body working correctly).
- Kidney function (measured by creatinine clearance, which shows how well your kidneys filter waste).
- Albumin (a protein in the blood).
- Liver function (measured by levels of ALT and AST, which are enzymes that can indicate liver health, and bilirubin, a yellow substance produced by the liver).
You must be 18 years of age or older.
Women must be either postmenopausal (no longer having menstrual periods) or pre/perimenopausal (still having periods or approaching menopause) and must be taking a specific medication called an LHRH agonist to manage hormone levels if they are not postmenopausal.
Your cancer must be ER positive (the cancer cells have receptors for the hormone estrogen) and HER-2 negative (the cancer cells do not have high levels of a specific protein that promotes cancer growth).
For the second part of the study, you must have at least one active and measurable brain metastasis (cancer that has spread to the brain and can be seen on a scan like a CT or MRI scan).
In the first part of the study, you do not need brain metastases, but you must have at least one measurable cancer lesion somewhere else in your body.
If you are taking corticosteroids (medicines that reduce inflammation), your dose must be stable or decreasing and must not be higher than a specific amount (4 mg of dexamethasone) for at least 7 days.
You must have previously received at least one endocrine therapy (treatment that interferes with hormones) and have used up to two types of chemotherapy (drugs used to kill cancer cells) and up to two types of CDK 4/6 inhibitors (a type of targeted medicine), excluding abemaciclib.
Any side effects from your previous treatments must have mostly resolved, meaning they are no longer severe.
Your cancer must have shown radiological progression (the cancer has grown or spread as seen on a scan) or recurrence (the cancer has come back) after your last treatment.
You must have an ECOG performance status of 2 or less, which is a scale used by doctors to measure how well you can perform daily activities and how much your cancer affects your lifestyle.

Who Cannot Join the Study?

You need immediate treatment specifically for the central nervous system, which is the part of the body containing the brain and spinal cord.
You are currently experiencing organ failure (when an organ stops working correctly) or a visceral crisis (a sudden, life-threatening medical emergency involving internal organs).
You have leptomeningeal metastases, which means the cancer has spread to the protective layers covering the brain and spinal cord, or it is found in the cerebrospinal fluid (the clear liquid that surrounds the brain and spinal cord).
You have never received any systemic therapy (medical treatment that travels through the entire body, such as pills or IV medicine) for your advanced or metastatic breast cancer.
You have previously taken abemaciclib to treat metastatic breast cancer, unless it was used as adjuvant therapy (treatment given after the main treatment to prevent the cancer from coming back) more than 12 months ago.
You have previously used elacestrant or other similar experimental drugs, such as SERDs, SERMs, SERCANs, CERANs, or PROTACs (different types of hormone-based or experimental cancer treatments), for metastatic breast cancer.
You have another type of cancer that started within the last 3 years, except for certain well-treated skin, bladder, or cervical cancers, or a second breast cancer that is currently in complete remission (a state where there are no signs or symptoms of the disease).
You are currently participating in another clinical study for breast cancer.
You have taken certain medications too recently, including:
- Fulvestrant (a hormone therapy) less than 42 days before starting the study.
- Other endocrine therapies (medicines that affect hormones) less than 14 days before starting.
- Chemotherapy or other cancer medicines less than 14 days before starting.
- Experimental cancer drugs within 28 days or 5 half-lives (the time it takes for the amount of a drug in your body to reduce by half).
- Bisphosphonates or RANKL inhibitors (medicines often used for bone health) within 1 month of starting.
You have taken certain foods, herbs, or medicines that affect cytochrome P450 3A4 (a specific enzyme in the liver that helps break down many drugs) within the last 14 days, or herbal supplements like ginseng, ginkgo biloba, or kava within the last 7 days.
You have had a pulmonary embolism (a blood clot in the lung), a cerebrovascular accident (a stroke), or a myocardial infarction (a heart attack) in the past 6 months.
You have had radiation therapy (the use of high-energy rays to kill cancer cells) within the last 7 days or have not fully recovered from its side effects.
You have an active, uncontrolled infection, or you have Hepatitis B or Hepatitis C with a detectable viral load (the amount of virus present in the blood).
You have HIV with a detectable viral load.
You have had major surgery within the last 4 weeks.
You are unable to swallow pills or have a condition like malabsorption syndrome (where the body cannot properly soak up nutrients or medicine from the gut) or other stomach issues that affect how medicine is absorbed.
Women of childbearing age who do not agree to use highly effective non-hormonal contraception (methods like an IUD or certain surgical procedures) and do not agree to avoid donating eggs during the study period.
Men who are able to father children and whose partners are of childbearing age, if they do not agree to use barrier contraception (such as condoms) or if they do not agree to avoid freezing or donating sperm during the study period.
You are currently pregnant or breastfeeding.
You have a known intolerance (a bad reaction or inability to handle) to the study drugs or any of the excipients (the inactive substances used to make up a pill, like fillers or coatings).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Medizinische Hochschule Hannover	Hanover	Germany
Centre Jean Perrin	Clermont Ferrand	France
Hospital Clinico San Carlos	Madrid	Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Universitaet Leipzig	Leipzig	Germany
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Euromedica General Clinic Of Thessaloniki	Thessaloniki	Greece
Centre De Cancerologue Du Grand Montpellier	Montpellier	France
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Azienda Ospedaliera Papardo	Messina	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Klinikum Worms gGmbH	Worms	Germany
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Universita’ Politecnica Delle Marche	Ancona	Italy
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Helios Universitaetsklinikum Wuppertal	Wuppertal	Germany
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Francois Baclesse	Caen	France
Metropolitan Hospital	Athens	Greece
Ctemuuxvs Uqelbmeuwmjqkm Slvmbfjru	Woluwe-Saint-Lambert	Belgium
Cnhudm Lzuq Btwkco	Lyon	France
Uzybsrjbxm Hqihzcle Cyuzdlf	Cologne	Germany
Imqayomx Ryutagcbm Plg La Sicbcb Dbn Tsrybt Dont Aiyvbas Iuts Sdvrll	Meldola	Italy
Uloakbhoorfoyztrctkjy Dgbojrklkmm Azm	Duesseldorf	Germany
Alfvxop Oflvnhdyujk Uxcajqhchwgzg Crfylglntbns Ddyad Spucmf E Dzlkz Sfyhqkv Dv Tdmiqy	Turin	Italy
Azmgtg Mzgaofe Ccmkpp Sfvo	Thessaloniki	Greece
Ktzfgzzh Bndncerz Gscm	Bayreuth	Germany
Uzdowougjj Ox Awbhfiu	Edegem	Belgium
Hkuptpym Viub deaekmrn	Barcelona	Spain
Uzllolgqul Glthuay Hkqwdygr Awrpbss	Athens	Greece

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.06.2022
France	Recruiting	01.06.2022
Germany	Recruiting	01.06.2022
Greece	Recruiting	01.06.2022
Italy	Recruiting	01.06.2022
Spain	Recruiting	01.06.2022

Trial locations

Investigated drugs:

Elacestrant is an oral medication taken as a tablet that is used to treat certain types of breast cancer. It works by blocking estrogen, a hormone that can help some cancer cells grow.

Abemaciclib is an oral medication used to treat breast cancer. It works by blocking specific proteins in the body that help cancer cells grow and divide.

Metastatic estrogen receptor-positive, human epidermal growth factor receptor2-negative breast cancer – This is a type of cancer where cells in the breast grow uncontrollably and use estrogen to fuel their development. The cancer is characterized by having receptors for estrogen but lacking high levels of a specific protein called HER2. This condition is considered metastatic when the cancer cells spread from the original breast site to other parts of the body. As the disease progresses, these cancer cells can form new tumors in distant organs. Brain metastasis from estrogen receptor-positive, HER-2 negative breast cancer – This occurs when breast cancer cells that are driven by estrogen and lack the HER2 protein spread specifically to the brain. The cancer cells travel through the bloodstream or lymphatic system to reach brain tissue. Once there, they begin to grow and form new masses within the brain. The disease continues to advance as these secondary tumors increase in size or number.

Trial ID:

2024-512878-98-00

Protocol code:

ELA-0121

NCT ID:

NCT05386108

Trial Phase:

Human Pharmacology (Phase I) – Other

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Phase 1b-2 Study of Elacestrant and Abemaciclib in Patients with Brain Metastases from ER-Positive, HER2-Negative Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?