Study on Lasofoxifene, Fulvestrant, and Abemaciclib for Advanced Breast Cancer in Women and Men with ESR1 Mutation

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What is this study about?

This clinical trial is focused on studying treatments for locally advanced or metastatic breast cancer, specifically in cases where the cancer is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) with an estrogen receptor 1 (ESR1) mutation. The study involves two treatment combinations: one group will receive a combination of Lasofoxifene and Abemaciclib, while the other group will receive a combination of Fulvestrant and Abemaciclib. These treatments are being tested to see how well they work and how safe they are for both pre- and postmenopausal women and men who have previously been treated with certain other medications.

The purpose of the study is to evaluate how long patients can live without their cancer getting worse when treated with these combinations. Participants will be randomly assigned to one of the two treatment groups. The study will involve taking medication in the form of tablets or injections over a period of time, with regular check-ups to monitor health and progress. The study aims to provide valuable information on the effectiveness of these treatment combinations for people with this specific type of breast cancer.

1 Joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and previous treatments.

A written informed consent is required before any procedures begin.

2 Initial assessment

An initial assessment is conducted to evaluate the current health status and medical history.

This may include imaging tests and laboratory evaluations to confirm the presence of specific mutations in the cancer cells.

3 Randomization

Participants are randomly assigned to one of two treatment groups.

One group receives a combination of lasofoxifene and abemaciclib, while the other group receives fulvestrant and abemaciclib.

4 Treatment administration

For the lasofoxifene and abemaciclib group, lasofoxifene is taken orally in tablet form, and abemaciclib is also taken orally in tablet form.

For the fulvestrant and abemaciclib group, fulvestrant is administered as an intramuscular injection, and abemaciclib is taken orally in tablet form.

The specific dosage and frequency are determined by the study protocol and monitored by the healthcare team.

5 Regular monitoring

Participants undergo regular monitoring to assess the effectiveness of the treatment and any side effects.

This includes routine visits for physical examinations, blood tests, and imaging studies.

6 Evaluation of progression

The primary goal is to evaluate progression-free survival, which is the time from the start of treatment until the disease progresses or the participant passes away.

Secondary evaluations include the objective response rate and overall survival.

7 Completion of the study

The study is estimated to conclude by October 2026.

Upon completion, participants may receive follow-up care and further assessments as needed.

Who Can Join the Study?

Must be at least 18 years old or older, depending on the country’s legal age of maturity.
Can be a premenopausal or postmenopausal woman or a man. Postmenopausal women are those who are 60 years or older with no vaginal bleeding for a year, or younger women with early menopause confirmed by specific hormone levels, or women who have had their ovaries removed.
Should have locally advanced or metastatic breast cancer that has shown signs of getting worse after certain treatments.
Must have had no signs of cancer getting worse for at least 6 months while on a specific combination of treatments for advanced breast cancer.
Must have specific changes (mutations) in a gene called ESR1, which can be found in blood or breast cancer tissue samples taken within 90 days before joining the study.
Should have breast cancer that is either measurable or not measurable according to specific guidelines.
May have had one chemotherapy treatment for metastatic cancer before joining the study, but must have recovered from any immediate side effects, except for hair loss and mild nerve damage. There should be a 14-day gap between the last chemotherapy dose and joining the study.
Must have a performance score of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
Must have proper functioning of organs, shown by specific blood test results.
Must be able to swallow tablets.
Must be able to understand and sign a consent form voluntarily before any study procedures.
If there are cancer spread areas in the brain, they must be without symptoms, treated, not needing steroids for 4 weeks before starting the study, and stable for more than 3 months as shown by an MRI scan.

Who Cannot Join the Study?

Patients who have not previously received treatment with ribociclib or palbociclib. These are specific medications used in treating breast cancer.
Patients who do not have locally advanced or metastatic breast cancer. This means the cancer has not spread beyond the breast or nearby areas.
Patients whose breast cancer is not estrogen receptor positive (ER+). This means the cancer does not grow in response to the hormone estrogen.
Patients whose breast cancer is human epidermal growth factor 2 negative (HER2-). This means the cancer does not have high levels of the HER2 protein.
Patients without an estrogen receptor 1 (ESR1) mutation. This is a specific change in the gene that can affect how the cancer behaves.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Technische Universitaet Dresden	Dresden	Germany
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o.	Cracow	Poland
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Centre Henri Becquerel	Rouen	France
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej	Biala Podlaska	Poland
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Oncomed S.R.L.	Timisoara	Romania
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Universita’ Degli Studi Di Verona	Verona	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Universita’ Politecnica Delle Marche	Ancona	Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Spitalul De Oncologie Monza S.R.L.	Bucharest	Romania
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Instytut Centrum Zdrowia Matki Polki	Lodz	Poland
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie	Poznan	Poland
Humanitas Istituto Clinico Catanese S.p.A.	Misterbianco	Italy
Radiotherapy Center Cluj S.R.L.	Floresti	Romania
Institut Sainte Catherine	Avignon	France
Mazowiecki Szpital Onkologiczny Sp. z o.o.	Wieliszew	Poland
Clinique Victor Hugo	Le Mans	France
Centre Francois Baclesse	Caen	France
Budapesti Uzsoki Utcai Korhaz	Budapest	Hungary
Chrvamtmf Unwgkkzuaypmrg Snrmcikkc	Woluwe-Saint-Lambert	Belgium
Itjxhpkz Rfrtsrsaa Pxj Li Sjbqxd Dfr Thwdel Dpta Amvowzl Isrg Slmonj	Meldola	Italy
Gojl Mtmndiw Szlugv	Bucharest	Romania
Omnt Cseerr Cmcyrvg Sceo	Craiova	Romania
Bhyifmcs Ubnrspfhfk Hrpeimrt Chelbp	Besançon	France
Axbujym Ozttrshvvqk Uvboehlfobinc Pmxqj	Parma	Italy
Ctvafl Ltsz Blxsjh	Lyon	France
Uldngltcly Of Axjfjrg	Edegem	Belgium
Hlwvdzaf Ueiiwxmlhyrkj Dy Lm Prknzphj	Madrid	Spain
Huuaghem Vxhz dhfwjimq	Barcelona	Spain
Igfjlmkl Phudyjmqibsqzae Cyzant Cpydem	Marseille	France
Cgxlqo Otxqw Lurqiis	Lille	France

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	13.10.2023
France	Recruiting	13.10.2023
Germany	Not yet recruiting	13.10.2023
Hungary	Not recruiting	13.10.2023
Italy	Recruiting	13.10.2023
Poland	Recruiting	13.10.2023
Romania	Recruiting	13.10.2023
Spain	Recruiting	13.10.2023

Trial locations

Investigated drugs:

Lasofoxifene is a medication being studied for its potential to treat breast cancer. It works by blocking the effects of estrogen in the body, which can help slow down or stop the growth of certain types of breast cancer cells that need estrogen to grow.

Abemaciclib is a cancer treatment that targets specific proteins in cancer cells, helping to stop their growth and division. It is used in combination with other medications to treat certain types of breast cancer, particularly those that are hormone receptor-positive.

Fulvestrant is a medication used to treat breast cancer by blocking and breaking down estrogen receptors on cancer cells. This action helps to slow the growth of cancer cells that rely on estrogen. It is often used in combination with other treatments for more effective results.

Investigated diseases:

Breast cancer metastatic

Locally Advanced or Metastatic Breast Cancer – This is a type of breast cancer that has spread beyond the breast to nearby tissues or other parts of the body. It is characterized by the presence of cancer cells in the lymph nodes or other organs, indicating that the disease has progressed beyond the initial site. The cancer can be either estrogen receptor-positive (ER+) or human epidermal growth factor receptor 2 negative (HER2-), which influences how the disease behaves and responds to treatment. In some cases, mutations in the estrogen receptor 1 (ESR1) gene may be present, affecting the cancer’s growth and progression. The disease can occur in both pre- and postmenopausal women, as well as in men. The progression of this cancer is typically monitored through various clinical endpoints, such as progression-free survival and objective response rate.

Trial ID:

2023-503708-10-00

Protocol code:

SMX 22-002

NCT ID:

NCT05696626

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Lasofoxifene, Fulvestrant, and Abemaciclib for Advanced Breast Cancer in Women and Men with ESR1 Mutation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?