Study on Elinzanetant for Treating Hot Flashes in Women with or at High Risk for Hormone-Receptor Positive Breast Cancer

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a medication called elinzanetant for treating hot flashes in women who are either undergoing or at high risk for developing hormone-receptor positive breast cancer. Hot flashes are sudden feelings of warmth, often associated with sweating, that can be caused by certain cancer treatments known as adjuvant endocrine therapy. This study aims to see how well elinzanetant works in reducing these symptoms compared to a placebo, which is a substance with no active medication.

Participants in the study will be randomly assigned to receive either elinzanetant or a placebo. The study will last for 52 weeks, with an option to continue for an additional two years. During this time, participants will take the medication in the form of soft capsules by mouth. The study will monitor changes in the frequency and severity of hot flashes over time, as well as any effects on sleep and quality of life.

The goal of the study is to provide more information about how elinzanetant can help manage hot flashes in women affected by hormone-receptor positive breast cancer treatments. By comparing the results between those taking elinzanetant and those taking a placebo, researchers hope to better understand the potential benefits and safety of this treatment option.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and current symptoms.

Participants must be women aged 18 to 70, experiencing hot flashes due to endocrine therapy, and have a history or high risk of hormone-receptor positive breast cancer.

2 baseline assessment

Participants complete a Hot Flash Daily Diary (HFDD) for at least 11 days in the two weeks before the baseline visit.

At least 35 moderate to severe hot flashes must be recorded over the last 7 days of diary completion.

3 treatment phase

Participants are randomly assigned to receive either the study medication, elinzanetant, or a placebo.

The medication is administered in the form of 60 mg soft capsules taken orally.

4 initial evaluation

The primary focus is on the change in frequency of moderate to severe hot flashes from the start of the study to Week 4 and Week 12.

Participants continue to record their symptoms in the HFDD.

5 extended evaluation

Secondary assessments include changes in the severity of hot flashes and other quality of life measures.

These assessments occur from baseline to Week 12 and may continue over a longer period if the participant remains in the study.

6 long-term follow-up

The study may extend for up to 52 weeks, with an optional additional 2 years for further observation.

Participants’ health and symptom changes are monitored throughout this period.

Who Can Join the Study?

  • Females aged 18 to 70 years old at the time of signing the informed consent.
  • Women experiencing vasomotor symptoms (like hot flashes) caused by adjuvant endocrine therapy (a treatment given in addition to the main treatment) that they are expected to use for the duration of the study. This includes:
    • Tamoxifen, with or without the use of gonadotropin-releasing hormone (GnRH) analogues (medicines that affect hormone levels).
    • Aromatase inhibitors, with or without the use of GnRH analogues.
  • Women must have either:
    • A personal history of hormone-receptor positive breast cancer (a type of breast cancer that grows in response to hormones).
    • A high risk for developing breast cancer.
  • Participant has completed the Hot Flash Daily Diary (HFDD) for at least 11 days during the two weeks before the baseline visit and has recorded at least 35 moderate to severe hot flashes (including night-time hot flashes) over the last 7 days that the HFDD was completed.
  • Contraceptive use by women (except for post-menopausal women or Women of Non-Childbearing Potential (WONCBP)) should follow local regulations regarding the methods of contraception for those participating in clinical studies.

Who Cannot Join the Study?

  • Women who are not experiencing vasomotor symptoms (like hot flashes) due to their breast cancer treatment cannot participate.
  • Women who are not receiving adjuvant endocrine therapy (a treatment to prevent cancer from returning) are excluded.
  • Women who do not have, or are not at high risk for developing, hormone-receptor positive breast cancer (a type of breast cancer that grows in response to hormones) cannot join the study.
  • Men are not eligible to participate in this study.
  • Individuals who are not considered part of a vulnerable population (groups that may need special protection) are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hopital Tenon Paris France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Universitair Ziekenhuis Gent Gent Belgium
CHU Saint Pierre Brussels Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Del Mar Barcelona Spain
Klinische Forschung Hannover-Mitte GmbH Hanover Germany
University Hospital Waterford Waterford Ireland
Oncolab S.R.L. Craiova Romania
Hospital Beatriz Angelo Loures Portugal
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Hospital Universitario Virgen De Las Nieves Granada Spain
Clinical Medical Research Sp. z o.o. Katowice Poland
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Ovidius Clinical Hospital S.R.L. Ovidiu Romania
Praxis für Gynäkologie und Geburtshilfe Bernburg Germany
Evangelisches Krankenhaus Bergisch Gladbach gGmbH Bergisch Gladbach Germany
Vaasa Central Hospital Vaasa Finland
Mehilaeinen Oy Helsinki Finland
Axon Kft. Kecskemet Hungary
Virgen del Rocío University Hospital Sevilla Spain
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Hospital Da Luz S.A. Lisbon Portugal
Champalimaud Clinical Centre Lisbon Portugal
University Hospital Galway Galway Ireland
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Gasthuiszusters Antwerpen Antwerp Belgium
Pratia S.A. Skorzewo Poland
St Vincent’s University Hospital Dublin Ireland
Ziekenhuis Oost Limburg Genk Belgium
Pirkanmaan hyvinvointialue Tampere Finland
Frauenarztpraxis Aurora Mannheim Germany
Centre Regional Lutte Contre Le Cancer STRASBOURG, Alsace France
Centre Francois Baclesse Caen France
Hospital CUF Porto S.A. Porto Portugal
Praxis für Frauenheilkunde und Geburtshilfe Halle (Saale) Germany
Ibnrzceq Rqzfvzpj Dt Cliuji Dm Miaysvtuwgu Montpellier France
Chmzup Left Bkjutw Lyon France
Foamhlvzzsx Ah Shdawuv Bdjyvsh Essen Germany
Dnw muzp Swhmsy Fpmxapx Aachen Germany
Mwrftxb Krefeld Germany
Luhihxkelnwshvaz Gzbmeo Oi Oulu Finland
Souiahbrtnbcimj Pnzuzlrd Gpgeznuvzfinvn Jaeaya Tzrsifgyanu supbu Bialystok Poland
Fdgzebxb Tienen Belgium
Tysrftd Pcg Kaim Szekesfehervar Hungary
Pvzuxxqg Gyafagx Lqtxwxdy Gmhyinyphsd I Plyqjepoqer Ulvaiouuykwnxy Petmn Jvynl Sdmyv Lodz Poland
Gdlzcmfdbsnknkny Zqcivss Bnxw Bonn Germany
Sctwnol Slyq Dg Hhbkzhswdh Barcelona Spain
Cfpalg Htgixfivzj E Uhcdsxahmqdex Dv Cbnmpht Egrdji Coimbra Portugal

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
14.10.2022
Belgium Belgium
Not recruiting
14.10.2022
Finland Finland
Not recruiting
14.10.2022
France France
Not recruiting
14.10.2022
Germany Germany
Not recruiting
14.10.2022
Hungary Hungary
Not recruiting
14.10.2022
Ireland Ireland
Not recruiting
14.10.2022
Italy Italy
Not recruiting
14.10.2022
Poland Poland
Not recruiting
14.10.2022
Portugal Portugal
Not recruiting
14.10.2022
Romania Romania
Not recruiting
14.10.2022
Spain Spain
Not recruiting
14.10.2022

Trial locations

Investigated drugs:

Elinzanetant is a medication being studied for its ability to treat vasomotor symptoms, such as hot flashes, which are caused by adjuvant endocrine therapy. This therapy is often used in women who have, or are at high risk for developing, hormone-receptor positive breast cancer. The study aims to determine how effective and safe elinzanetant is over a period of 52 weeks, with an optional extension for an additional 2 years.

Vasomotor Symptoms – These are symptoms such as hot flashes and night sweats that occur due to changes in blood vessel regulation. They are commonly experienced by women undergoing menopause or those receiving certain hormone therapies. The symptoms can vary in frequency and severity, often causing discomfort and affecting daily activities. In the context of hormone-receptor positive breast cancer, these symptoms may be exacerbated by adjuvant endocrine therapy. The progression involves fluctuations in body temperature and can lead to sleep disturbances and reduced quality of life. Management focuses on alleviating these symptoms to improve overall well-being.

Trial ID:
2023-508265-33-00
Protocol code:
21656
NCT ID:
NCT05587296
Trial Phase:
Therapeutic confirmatory (Phase III)

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