AzTrials
AzTrials

Hot FlashesPhase 3NCT06440967

A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy

A Phase 3 study testing Fezolinetant, Tamoxifen and Aromatase inhibitor in people with Hot Flashes, run by Astellas Pharma Global Development, Inc. at 110 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

One of the standard treatments for women with breast cancer is hormone therapy, but this treatment can cause hot flashes. Hormone replacement therapy, or HRT, is most often prescribed for hot flashes for women in menopause but cannot be given to women on hormone therapy for breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Hot Flashes
What is being tested?
Fezolinetant, Tamoxifen and Aromatase inhibitor
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
982 participants
Where
110 sitesin 11 countries
Study dates
31 Jul 2024to 30 Apr 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant has a personal history of stage 0-3 hormone receptor positive (HR+), either human epidermal growth factor receptor (HER)-2+ or HER-2- breast cancer; appropriate documentation includes a written or electronic report.
  • Participant must be receiving stable maintenance adjuvant endocrine therapy (e.g., tamoxifen or aromatase inhibitors, such as anastrozole, letrozole and exemestane) with or without gonadotropin-releasing hormone (GnRH) agonists/antagonists for a minimum of 4 months prior to randomization and be planning to continue on adjuvant endocrine therapy for the duration of the trial without change to therapy, brand or dose. If the participant is taking GnRH agonists/antagonists, therapy must also be stable for a minimum of 4 months prior to randomization. Add-on therapies for breast cancer adjuvant treatment (e.g., cyclin dependent kinase-4 (CDK4) inhibitors) are allowed.
  • Participant has a minimum average of 7 moderate to severe hot flashes (HFs) (vasomotor symptoms (VMS)) per day as recorded in the electronic daily diary (data must be available for at least 7 of the last 10 days prior to randomization).
  • Has an European Cooperative Oncology Group (ECOG) score 0 or 1.
  • Has at least 12-month life expectation.
  • Participant is born female.
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  • Female participant: Is not pregnant and at least 1 of the following conditions apply:
  • Not a woman of childbearing potential (WOCBP)
  • WOCBP who has a negative urine or serum pregnancy test at screening and day 1 and agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after final investigational study intervention administration.
  • Female participant: Must not be breastfeeding or lactating starting at screening and while the participant is taking investigational study intervention and for 30 days after final investigational study intervention administration.
  • Female participant: Must not donate ova starting at first administration of study intervention and while the participant is taking investigational study intervention and for 30 days after final investigational study intervention administration.
  • Participant agrees not to participate in another interventional study while participating in the present study until the end of the 1-year extension follow-up period.
  • Participant's condition is stable as determined on the basis of medical history and general physical examination, hematology and biochemistry parameters, pulse rate and/or blood pressure and electrocardiogram (ECG) (or showing no clinically relevant deviations obtained within the last 3 months or at screening).
  • Participant has no new clinically significant findings on breast examination or from imaging (mammogram, breast ultrasound or equivalent). Results indicate that the participant is a good candidate for the study. Appropriate documentation includes a written or electronic report. In case of double mastectomy, imaging is not needed.
  • Participant has a negative serology panel (including hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody and human immunodeficiency virus (HIV) antibody screens).

Who cannot join

  • Participant has diagnosis of metastatic breast cancer (stage 4).
  • Participant has current or history (except complete remission for 5 years or more prior to signing informed consent) of any malignancy except for HR+ breast cancer (stage 0 to 3) or basal cell carcinoma.
  • Participant has had surgery or non-surgical (chemotherapy or radiotherapy) treatment for breast cancer within the last 3 months prior to signing informed consent.
  • Participant has active liver disease, jaundice, or elevated liver aminotransferases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST)), elevated total bilirubin (TBL) or direct bilirubin (DBL), or elevated alkaline phosphatase (ALP) at screening. A participant with mildly elevated ALT or AST up to < 2 × upper limit of normal (ULN) can be enrolled if TBL and DBL are normal. Participant with mildly elevated ALP (up to < 1.5 × ULN) can be enrolled if cholestatic liver disease is excluded and no cause other than fatty liver is diagnosed. Participant with Gilbert's syndrome with elevated TBL may be enrolled as long as DBL, hemoglobin and reticulocytes are normal.
  • Participant has creatinine > 1.5 x ULN; or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease formula < 30 mL/min/1.73 m2 at the screening visit.
  • Participant has a history of endometrial hyperplasia (participant can be enrolled if she has undergone a hysterectomy) or uterine/endometrial cancer.
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  • Participant has a medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary [e.g., moderate asthma], endocrine, or gynecological disease) or malignancy that could confound interpretation of the study outcome.
  • Participant uses a prohibited therapy (menopause hormone therapy (MHT), estradiol-containing hormonal contraceptive progestin and progesterone-only medicines, any treatment for VMS [prescription medications, over-the-counter, or herbal] or CYP1A2 (cytochrome P450) inhibitors) or is not willing to wash out such drugs; in addition, medications that are contraindicated due to underlying breast cancer diagnosis and the adjuvant endocrine therapy.
  • Participant has a known substance abuse or alcohol addiction within 6 months of screening.
  • Participant has received any investigational therapy within 90 days or 5 half-lives, whichever is longer, prior to screening.
  • Participant has any condition, which makes the participant unsuitable for study participation.
  • Participant has a known or suspected hypersensitivity to fezolinetant, the adjuvant endocrine therapy being used, or any components of the formulations used.

Trial locations and contacts

110 sites in 11 countries.

110 sites in 11 countries

Spain19 sites

  • Site ES34011

    Barcelona

  • Site ES34020

    Barcelona

  • Site ES34010

    Elche

  • Site ES34003

    Girona

  • Site ES34005

    Granada

  • Site ES34006

    Jaén

  • Site ES34017

    León

  • Site ES34007

    Madrid

  • Site ES34019

    Madrid

  • Site ES34022

    Madrid

  • Site ES34023

    Madrid

  • Site ES34015

    Majadahonda

  • Site ES34002

    Murcia

  • Site ES34014

    Murcia

  • Site ES34008

    Palma

  • Site ES34025

    Rivas-Vaciamadrid

  • Site ES34009

    Seville

  • Site ES34024

    Seville

  • Site ES34013

    Valencia

Other trials in Spain

Poland14 sites

  • Site PO48005

    Bialystok

  • Site PO48006

    Bydgoszcz

  • Site PO48004

    Katowice

  • Site PO48017

    Katowice

  • Site PO48015

    Krakow

  • Site PO48021

    Krakow

  • Site PO48007

    Lodz

  • Site PO48012

    Lodz

  • Site PO48019

    Poznan, Skorzewo

  • Site PO48002

    Poznan

  • Site PO48018

    Poznan

  • Site PO48003

    Świdnik

  • Site PO48010

    Szczecin

  • Site PO48001

    Warsaw

Other trials in Poland

United Kingdom14 sites

  • Site GB44018

    Aberdeen

  • Site GB44008

    Bebington, Birkenhead

  • Site GB44019

    Birmingham

  • Site GB44003

    Bristol

  • Site GB44016

    Cambridge

  • Site GB44006

    Glasgow

  • Site GB44009

    Guildford, Surrey

  • Site GB44002

    Liverpool

  • Site GB44020

    Liverpool

  • Site GB44005

    London

  • Site GB44017

    Oxford

  • Site GB44001

    Preston Lancashire

  • Site GB44012

    Redhill

  • Site GB44010

    Stroke on Trent

Other trials in United Kingdom

Czechia11 sites

  • Site CZ42006

    České Budějovice

  • Site CZ42003

    Hořovice

  • Site CZ42002

    Hradec Králové

  • Site CZ42011

    Nový Jičín

  • Site CZ42001

    Olomouc

  • Site CZ42005

    Prague

  • Site CZ42008

    Prague

  • Site CZ42013

    Prague

  • Site CZ42004

    Tábor

  • Site CZ42007

    Vodňany

  • Site CZ42009

    Vsetín

Other trials in Czechia

France11 sites

  • Site FR33003

    Angers

  • Site FR33001

    Bayonne

  • Site FR33005

    Bordeaux

  • Site FR33018

    Bordeaux

  • Site FR33017

    Caen

  • Site FR33016

    Dijon

  • Site FR33013

    Le Mans

  • Site FR33007

    Lille

  • Site FR33012

    Lyon

  • Site FR33008

    Montpellier

  • Site FR33002

    Saint-Herblain

Other trials in France

Canada8 sites

  • Site CA15002

    Montreal, Quebec

  • Site CA15001

    Québec, Quebec

  • Site CA15004

    Québec, Quebec

  • Site CA15019

    Sarnia, Ontario

  • Site CA15016

    Sault Ste. Marie, Ontario

  • Site CA15003

    Sherbrooke, Quebec

  • Site CA15007

    Trois-Rivières

  • Site CA15020

    Victoriaville, Quebec

Other trials in Canada

Germany8 sites

  • Site DE49001

    Bottrop

  • Site GR49013

    Dresden

  • Site GR49005

    Essen, North Rhine-Westphalia

  • Site DE49009

    Leipzig

  • Site DE49007

    Mönchengladbach

  • Site DE49010

    München

  • Site GR49003

    Münster

  • Site GR49014

    Wolfsburg

Other trials in Germany

Italy7 sites

  • Site IT39011

    Bologna

  • Site IT39015

    Genova

  • Site IT39003

    Milan

  • Site IT39013

    Mirano

  • Site IT39017

    Pavia

  • Site IT39018

    Reggio Emilia

  • Site IT39012

    Terni

Other trials in Italy

Netherlands7 sites

  • Site NL31010

    Breda

  • Site NL31006

    Dirksland

  • Site NL31001

    Haarlem

  • Site NL31002

    Rotterdam

  • Site NL31004

    Rotterdam

  • Site NL31012

    Rotterdam

  • Site NL31009

    Terneuzen

Other trials in Netherlands

Hungary6 sites

  • Site HU36008

    Budapest

  • Site HU36006

    Debrecen

  • Site HU36001

    Eger

  • Site HU36002

    Kecskemét

  • Site HU36010

    Salgótarján

  • Site HU36003

    Székesfehérvár

Other trials in Hungary

Denmark5 sites

  • Site DK45007

    Aalborg

  • Site DE45003

    Esbjerg

  • Site DK45009

    Hillerød

  • Site DK45002

    Næstved

  • Site DE45008

    Sønderborg

Other trials in Denmark

About this study

Official title: A Randomized, Placebo-controlled, Double-blind, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms (Hot Flashes) in Women With Stage 0 to 3 Hormone Receptor-positive Breast Cancer Who Are Receiving Adjuvant Endocrine Therapy

One of the standard treatments for women with breast cancer is hormone therapy, but this treatment can cause hot flashes. Hormone replacement therapy, or HRT, is most often prescribed for hot flashes for women in menopause but cannot be given to women on hormone therapy for breast cancer. Fezolinetant, an alternative to HRT, treats hot flashes for women in menopause. As hot flashes happen in the same way for women on hormone therapy for breast cancer, fezolinetant could help these women. In this study, women on hormone therapy for breast cancer who have moderate to severe hot flashes will take part. They will either take fezolinetant or a placebo to treat their hot flashes. The placebo looks like fezolinetant but doesn't have any medicine in it.

The main aim of this study is to confirm if women who take fezolinetant have fewer hot flashes that are less severe compared to women who take the placebo.

Read more

Women 18 years or older seeking treatment for hot flashes. They can take part in the study if they have an average of 7 or more moderate to severe hot flashes each day. They are having hormone therapy for breast cancer from stage 0 (cancer cells that have not spread to nearby tissue) up to stage 3+ (the cancer has spread from the breast to the lymph nodes near the breast or the chest wall).

The women will be assigned 1 of 2 study treatments (fezolinetant or placebo) by chance alone. Treatment will be double-blinded. That means that the women in the study and the study doctors will not know who takes which of the study treatments (fezolinetant or placebo). Women who take part in the study will take 1 tablet every day for 52 weeks (1 year). Each woman will be given an electronic handheld device with an app to track their hot flashes on a daily basis. Some women may be able to use the app on their own smartphone. They will also use another device to answer questions about how hot flashes affect their daily life. During the study, the women will visit their study clinic about every 4 weeks for a health check. The last clinic visit will be 3 weeks after the women take their last tablet of study treatment (fezolinetant or placebo). After this visit the women will be called twice to check their health. The women will be in the study for about 2 years.

Conditions
Hot Flashes
Being tested
Fezolinetant, Placebo, Tamoxifen, Aromatase inhibitor
Keywords
ESN364;, vasomotor symptoms;, fezolinetant;, VEOZAH™
Medical subject headings
Hot Flashes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FezolinetantDrug

    Also called ESN364;, VEOZAH™

    oral

  • PlaceboDrug

    oral

  • TamoxifenDrug

    oral

  • Aromatase inhibitorDrug

    oral

Study groups in NCT06440967
Study groupRoleWhat they receive
FezolinetantExperimentalParticipants taking tamoxifen or an aromatase inhibitor will receive fezolinetant once daily for 52 weeks. After the end of the 52 week treatment period, participants will continue to participate in the extension follow up until week 104. They will continue to receive the adjuvant endocrine therapy as needed.
Receives: Drug: Fezolinetant; Drug: Tamoxifen; Drug: Aromatase inhibitor
PlaceboPlacebo comparatorParticipants taking tamoxifen or an aromatase inhibitor will receive matching placebo once daily for 52 weeks. After the end of the 52 week treatment period, participants will continue to participate in the extension follow up until week 104. They will continue to receive the adjuvant endocrine therapy as needed.
Receives: Drug: Placebo; Drug: Tamoxifen; Drug: Aromatase inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change from Baseline to Week 4 in the frequency of moderate to severe VMS

    Frequency of moderate and severe vasomotor symptoms (VMS) events will be calculated as the sum of moderate and severe VMS events per day.

    Measured: Baseline to Week 4

  2. Mean change from Baseline to Week 12 in the frequency of moderate to severe VMS

    Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day.

    Measured: Baseline to Week 12

  3. Mean change from Baseline to Week 4 in the severity of moderate to severe VMS

    The severity of VMS will be calculated using a weighted average of VMS events.

    Measured: Baseline to Week 4

  4. Mean change from Baseline to Week 12 in the severity of moderate to severe VMS

    The severity of VMS will be calculated using a weighted average of VMS events.

    Measured: Baseline to Week 12

Secondary outcomes (55)

  1. Mean change from Baseline to Week 12 in the MENQOL VMS 1 week recall domain score

    The Menopause-specific Quality of Life Questionnaire (MENQOL) is a 29-item patient-reported outcome (PRO) measure that assesses the impact of 4 domains of menopausal symptoms, as experienced over the last week: vasomotor, psychosocial, physical and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. The overall questionnaire score is the mean of the domain means. Higher scores represent more bothersome menopausal symptoms. A reduction (improvement) of 1 is the minimum clinically important difference in MENQoL.

    Measured: Baseline to Week 12

  2. Mean Change from Baseline to Week 12 in the PROMIS SD SF 8b Total (raw) Score

    The Patient-reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b) assesses self-reported sleep disturbance over the past 7 days and includes perceptions of: restless sleep; satisfaction with sleep; refreshing sleep; difficulties sleeping, getting to sleep or staying asleep; amount of sleep; and sleep quality. Responses to each of the 8 items range from 1 to 5 and the range of possible summed raw scores is 8 to 40. Higher scores on the PROMIS SD SF 8b indicate more of the concept measured (disturbed sleep).

    Measured: Baseline to Week 12

  3. Mean change from Baseline to Week 24 in the frequency of moderate to severe VMS

    Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day.

    Measured: Baseline to Week 24

  4. Mean Change from Baseline to Week 24 in the severity of moderate to severe VMS

    The severity of VMS will be calculated using a weighted average of VMS events.

    Measured: Baseline to Week 24

  5. Number of participants with Treatment Emergent Adverse Events (TEAEs)

    A TEAE is defined as Adverse Event (AE) observed after starting administration of the investigational study intervention and up to 21 days after the last dose of investigational study intervention.

    Measured: Up to Week 55

  6. Number of participants with Adverse Events of Special Interest (AESIs)

    AEs of special interest in this study will include: Progression of breast cancer including metastasis; Adverse events of uterine bleeding; Adverse events of liver test elevations; Any liver AE leading to discontinuation.

    Measured: Up to Week 55

  7. Number of participants with laboratory value abnormalities and/or adverse events (AEs)

    Number of participants with potentially clinically significant laboratory values.

    Measured: Up to Week 55

  8. Number of participants with vital sign abnormalities and/or adverse events (AEs)

    Number of participants with potentially clinically significant vital sign values.

    Measured: Up to Week 55

  9. Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)

    Number of participants with potentially clinically significant ECG values.

    Measured: Up to Week 52

  10. Mean change from Baseline in the frequency of moderate to severe VMS to the average frequency of moderate to severe VMS over Weeks 1 to 3

    Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day.

    Measured: Baseline and Weeks 1 to 3

  11. Mean Change from Baseline in the frequency of moderate to severe VMS to the average frequency of moderate to severe VMS over Weeks 5 to 11

    Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day.

    Measured: Baseline and Weeks 5 to 11

  12. Mean change from Baseline in the severity of moderate to severe VMS to the average severity of moderate to severe VMS over weeks 1 to 3

    The severity of VMS will be calculated using a weighted average of VMS events.

    Measured: Baseline and Weeks 1 to 3

  13. Mean Change from Baseline in the severity of moderate to severe VMS to the average severity of moderate to severe VMS over weeks 5 to 11

    The severity of VMS will be calculated using a weighted average of VMS events.

    Measured: Baseline and Weeks 5 to 11

  14. Percent reduction >/= 50% in the frequency of moderate and severe VMS from baseline

    Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. Percent reduction of >/= 50% will be reported.

    Measured: Baseline to Weeks 1, 4, 8 and 12

  15. Percent reduction >/= 75% in the frequency of moderate and severe VMS from baseline

    Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. Percent reduction of >/= 75% will be reported.

    Measured: Baseline to Weeks 1, 4, 8 and 12

  16. Percent reduction at 100% in the frequency of moderate and severe VMS from baseline

    Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. Percent reduction of 100% will be reported.

    Measured: Baseline to Weeks 1, 4, 8 and 12

  17. Pharmacokinetics (PK) of Fezolinetant in Plasma: Apparent Clearance (CL/F) for participants taking tamoxifen

    CL/F will be derived using a population PK model.

    Measured: Up to Week 24

  18. Pharmacokinetics (PK) of Fezolinetant in Plasma: Apparent Clearance (CL/F) for participants taking aromatase inhibitors

    CL/F will be derived using a population PK model.

    Measured: Up to Week 24

  19. PK of Fezolinetant in Plasma: apparent volume of distribution (Vc/F) for participants taking tamoxifen

    Vc/F will be derived using a population PK model.

    Measured: Up to Week 24

  20. PK of Fezolinetant in Plasma: apparent volume of distribution (Vc/F) for participants taking aromatase inhibitors

    Vc/F will be derived using a population PK model.

    Measured: Up to Week 24

  21. PK of Fezolinetant in Plasma: average concentration (Cavg) for participants taking tamoxifen

    Cavg will be derived using a population PK model.

    Measured: Up to Week 24

  22. PK of Fezolinetant in Plasma: Cavg for participants taking aromatase inhibitors

    Cavg will be derived using a population PK model.

    Measured: Up to Week 24

  23. PK of Fezolinetant in Plasma: trough concentration (Ctrough) for participants taking tamoxifen

    Ctrough will be derived using a population PK model.

    Measured: Up to Week 24

  24. PK of Fezolinetant in Plasma: Ctrough for participants taking aromatase inhibitors

    Ctrough will be derived using a population PK model.

    Measured: Up to Week 24

  25. PK of tamoxifen in Plasma: CL/F

    CL/F will be derived using a population PK model.

    Measured: Up to Week 24

  26. PK of tamoxifen in Plasma: Vc/F

    Vc/F will be derived using a population PK model.

    Measured: Up to Week 24

  27. PK of tamoxifen in Plasma: Cavg

    Cavg will be derived using a population PK model.

    Measured: Up to Week 24

  28. PK of tamoxifen in Plasma: Ctrough

    Ctrough will be derived using a population PK model.

    Measured: Up to Week 24

  29. PK of tamoxifen Metabolite 4-OH tamoxifen in Plasma: CL/F

    CL/F will be derived using a population PK model.

    Measured: Up to Week 24

  30. PK of tamoxifen Metabolite 4-OH tamoxifen in Plasma: Vc/F

    Vc/F will be derived using a population PK model.

    Measured: Up to Week 24

  31. PK of tamoxifen Metabolite 4-OH tamoxifen in Plasma: Cavg

    Cavg will be derived using a population PK model.

    Measured: Up to Week 24

  32. PK of tamoxifen Metabolite 4-OH tamoxifen in Plasma: Ctrough

    Ctrough will be derived using a population PK model.

    Measured: Up to Week 24

  33. PK of tamoxifen Metabolite N-desmethyltamoxifen in Plasma: CL/F

    CL/F will be derived using a population PK model.

    Measured: Up to Week 24

  34. PK of tamoxifen Metabolite N-desmethyltamoxifen in Plasma: Vc/F

    Vc/F will be derived using a population PK model.

    Measured: Up to Week 24

  35. PK of tamoxifen Metabolite N-desmethyltamoxifen in Plasma: Cavg

    Cavg will be derived using a population PK model.

    Measured: Up to Week 24

  36. PK of tamoxifen Metabolite N-desmethyltamoxifen in Plasma: Ctrough

    Ctrough will be derived using a population PK model.

    Measured: Up to Week 24

  37. PK of tamoxifen Metabolite endoxifen in Plasma: CL/F

    CL/F will be derived using a population PK model.

    Measured: Up to Week 24

  38. PK of tamoxifen Metabolite endoxifen in Plasma: Vc/F

    Vc/F will be derived using a population PK model.

    Measured: Up to Week 24

  39. PK of tamoxifen Metabolite endoxifen in Plasma: Cavg

    Cavg will be derived using a population PK model.

    Measured: Up to Week 24

  40. PK of tamoxifen Metabolite endoxifen in Plasma: Ctrough

    Ctrough will be derived using a population PK model.

    Measured: Up to Week 24

  41. PK of aromatase inhibitors in Plasma: CL/F

    CL/F will be derived using a population PK model.

    Measured: Up to Week 24

  42. PK of aromatase inhibitors in Plasma: Vc/F

    Vc/F will be derived using a population PK model.

    Measured: Up to Week 24

  43. PK of aromatase inhibitors in Plasma: Cavg

    Cavg will be derived using a population PK model.

    Measured: Up to Week 24

  44. PK of aromatase inhibitors in Plasma: Ctrough

    Ctrough will be derived using a population PK model.

    Measured: Up to Week 24

  45. Mean change from Baseline in the MENQOL Total Score

    The MENQOL is a 29-item PRO measure that assesses the impact of 4 domains of menopausal symptoms, as experienced over the last week: vasomotor, psychosocial, physical and sexual. The total score is the mean of the domain means. Higher scores represent more bothersome menopausal symptoms. A reduction (improvement) of 1 is the minimum clinically important difference for the MENQoL.

    Measured: Baseline to Weeks 4, 8, 12 and 24

  46. Mean change from Baseline in the MENQOL VMS 1-week recall domain score

    The MENQOL is a 29-item PRO measure that assesses the impact of 4 domains of menopausal symptoms, as experienced over the last week: vasomotor, psychosocial, physical and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. Higher scores represent more bothersome menopausal symptoms.

    Measured: Baseline to Weeks 4, 8 and 24

  47. Mean change from Baseline in the MENQOL psychosocial 1-week recall domain score

    The MENQOL is a 29-item PRO measure that assesses the impact of 4 domains of menopausal symptoms, as experienced over the last week: vasomotor, psychosocial, physical and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. Higher scores represent more bothersome menopausal symptoms.

    Measured: Baseline to Weeks 4, 8, 12 and 24

  48. Mean change from Baseline in the MENQOL physical 1-week recall domain score

    The MENQOL is a 29-item PRO measure that assesses the impact of 4 domains of menopausal symptoms, as experienced over the last week: vasomotor, psychosocial, physical and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. Higher scores represent more bothersome menopausal symptoms.

    Measured: Baseline to Weeks 4, 8, 12 and 24

  49. Mean change from Baseline in the MENQOL sexual 1-week recall domain score

    The MENQOL is a 29-item PRO measure that assesses the impact of 4 domains of menopausal symptoms, as experienced over the last week: vasomotor, psychosocial, physical and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. Higher scores represent more bothersome menopausal symptoms.

    Measured: Baseline to Weeks 4, 8, 12 and 24

  50. Mean change from Baseline in the PROMIS SD SF 8b Total (raw) Score

    The PROMIS SD SF 8b assesses self reported sleep disturbance over the past 7 days and includes perceptions of: restless sleep; satisfaction with sleep; refreshing sleep; difficulties sleeping, getting to sleep or staying asleep; amount of sleep; and sleep quality. Responses to each of the 8 items range from 1 to 5 and the range of possible summed raw scores is 8 to 40. Higher scores on the PROMIS SD SF 8b indicate more of the concept measured (disturbed sleep).

    Measured: Baseline to Weeks 4, 8 and 24

  51. Scores on the Patient Global Impression of Change (PGI-C) VMS

    The PGI-C VMS evaluates patient perceived change in hot flashes/night sweats from the initiation of treatment. Ratings range from (1) much better to (7) much worse.

    Measured: Up to Week 24

  52. Change from Baseline in the Patient Global Impression of Severity (PGI-S) VMS Score

    The PGI-S VMS evaluates patient perceived severity of hot flashes/night sweats. Ratings range from (1) no problems to (4) severe problems.

    Measured: Baseline to Weeks 4, 8, 12 and 24

  53. Scores on the PGI-C sleep disturbance (SD)

    PGI-C SD evaluates patient perceived change in sleep disturbance from the initiation of treatment. Ratings range from (1) much better to (7) much worse.

    Measured: Up to Week 24

  54. Change from Baseline in the PGI-S SD Score

    The PGI-S SD evaluates patient perceived severity of sleep disturbance. Ratings range from (1) no problems to (4) severe problems.

    Measured: Baseline to Weeks 4, 8, 12 and 24

  55. PGI-S SD response

    Proportion of patients achieving a response in PGI-S SD. The PGI-S SD evaluates patient perceived severity of sleep disturbance. Ratings range from (1) no problems to (4) severe problems. PGI-S SD response is defined as at least 2 levels of improvement on PGI-S SD from baseline. Non-response is defined as not achieving a response.

    Measured: Up to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2024
  2. Study start31 Jul 2024
  3. Primary completion25 Jun 2026
  4. Study completion30 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
982 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06440967
Sponsor's protocol ID
2693-CL-1303
Other IDs
2024-510719-31-00
Status last verified
Sep 2026
First submitted
29 May 2024
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

  • Liao C, Pal L. Novel Pharmacotherapies for Menopausal Symptoms. Obstet Gynecol. 2025 Oct 1;146(4):473-486. doi: 10.1097/AOG.0000000000006025. Epub 2025 Aug 7.

    PubMed 40773756

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fezolinetant, Tamoxifen and Aromatase inhibitor in people with Hot Flashes, run by Astellas Pharma Global Development, Inc. at 110 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in Spain, Poland, United Kingdom, Czechia, France and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from Baseline to Week 4 in the frequency of moderate to severe VMS (time frame: Baseline to Week 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06440967, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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