Breast Cancer Clinical Trial

A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause

Summary

This study is for women in menopause with hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life.

The purpose of this study is to find out how safe it is for these women to take fezolinetant long term (up to 52 weeks). To do that, the study will look at the number and severity of the "adverse events." Those are the side effects that study participants have while they are in the study.

The study treatments are fezolinetant low dose (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant high dose (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. (Placebo is a dummy treatment that looks like medicine but does not have any medicine in it.) Women in this study will be picked for 1 of the 3 study treatments by chance alone. The study participants will take study treatment for 52 weeks.

This study is "double-blinded." That means that the study participants and the study doctors do not know who takes which of the study treatments (fezolinetant low dose, fezolinetant high dose or placebo).

At weeks 2 and 4 and then once a month, the study participants will go the hospital or clinic for a check-up. They will be asked about medications, side effects and how they feel. Other checks will include physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine will be collected for laboratory tests. At some study visits, study participants will complete questionnaires that are about their quality of life. At the first and last study visits, they will have a dual-energy x-ray absorptiometry (DXA for short) test done. To measure bone loss in the hips and spine, DXA creates pictures of the inside of these areas with low-dose x-rays. (The dose is approximately one-tenth of the amount of a normal chest x-ray.) Study participants who still have their uterus will have 2 more tests done at the first and last study visits. One of the 2 tests is endometrial biopsy. This test involves removing a small amount of tissue from the inside lining of the uterus. The tissue is then checked under a microscope. The other test is transvaginal ultrasound. It uses sound waves to create pictures of the organs in the pelvis. The sound waves are transmitted by a probe (transducer), which is placed inside the vagina. Study participants may have a screening mammogram done at the first and/or last study visit. A mammogram is an x-ray picture of the breasts used to screen for breast cancer. Study participants who did not have this test done in the last 12 months will have it done at the first study visit. They will have it done at the last study visit if they are due for their screening mammogram and their own doctor agrees.

The last check-up at the hospital or clinic will be 3 weeks after the last dose of study treatment.

View Full Description

Full Description

This study will consist of a screening period and a 52 week treatment period. Safety follow up will occur 3 weeks after the last dose of study drug.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Subject has a body mass index ≥ 18 kg/m^2 and ≤ 38 kg/m^2.

Subject must be seeking treatment or relief for vasomotor symptoms (VMS) associated with menopause and confirmed as menopausal per 1 of the following criteria at the screening visit:

Spontaneous amenorrhea for ≥ 12 consecutive months
Spontaneous amenorrhea for ≥ 6 months with biochemical criteria of menopause (follicle stimulating hormone > 40 IU/L), or
Having had bilateral oophorectomy ≥ 6 weeks prior to the screening visit.
Subject is seeking treatment for relief for VMS associated with menopause.
Subject is in good general health as determined on the basis of medical history and general physical examination, including a bimanual clinical pelvic examination and clinical breast examination devoid of relevant clinical findings, performed at the screening visit; hematology and biochemistry parameters; pulse rate and/or blood pressure; and ECG within the reference range for the population studied, or showing no clinically relevant deviations.
Subject has documentation of a normal/negative or no clinically significant mammogram findings (obtained at screening or within the prior 12 months of study enrollment). Appropriate documentation includes a written report or an electronic report indicating normal/negative or no clinically significant mammographic findings.
Subject is willing to undergo a transvaginal ultrasound (TVU) to evaluate the uterus and ovaries at screening and at week 52 end of treatment (EOT). For subjects who are withdrawn from the study prior to completion, a TVU should be collected at the early discontinuation (ED) visit.
Subject is willing to undergo an endometrial biopsy at screening and at week 52 (EOT) or the ED visit for subjects who are withdrawn from the study prior to completion, and any time during the study in the case of uterine bleeding. The endometrial biopsy obtained at screening must be considered evaluable.
Subject has documentation of a normal or not clinically significant Papanicolaou (Pap) test (or equivalent cervical cytology) within the previous 12 months or at screening.
Subject has a negative urine pregnancy test at screening.
Subject has a negative serology panel (i.e., negative hepatitis B surface antigen, negative hepatitis C virus antibody and negative human immunodeficiency virus antibody screens) at screening.
Subject agrees not to participate in another interventional study while participating in the present study.

Exclusion Criteria:

Subject uses a prohibited therapy (strong or moderate cytochrome P450 [CYP] 1A2 inhibitors, hormone replacement therapy [HRT], hormonal contraceptive, any treatment for VMS [prescription, over the counter or herbal]) or is not willing to wash out and discontinue such drugs for the full extent of the study.
Subject has a known substance abuse or alcohol addiction within 6 months of screening.
Subject has previous or current history of a malignant tumor, except for basal cell carcinoma.

Subject's systolic blood pressure is ≥ 130 mmHg or diastolic blood pressure is ≥ 80 mmHg based on the average of 2 to 3 readings, on at least 2 different occasions within the screening period.

Subjects who do not meet these criteria may be re-assessed after initiation or review of antihypertensive measures.
Subjects with a medical history of hypertension can be enrolled once they are medically clear (stable and compliant).
Subject has a history of severe allergy, hypersensitivity or intolerance to drugs in general, including the study drug and any of its excipients.
Subject has an unacceptable result from the TVU assessment at screening, i.e., full length of endometrial cavity cannot be visualized or presence of a clinically significant finding.
Subject has an endometrial biopsy confirming presence of disordered proliferative endometrium, endometrial hyperplasia, endometrial cancer, or other clinically significant findings at screening.
Subject has a history within the last 6 months of undiagnosed uterine bleeding.
Subject has a history of seizures or other convulsive disorders.
Subject 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.
Subject has active liver disease, jaundice or elevated liver aminotransferases (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]), elevated total or direct bilirubin, elevated international normalized ratio (INR), or elevated alkaline phosphatase (ALP). Patients with mildly elevated ALT or AST up to 1.5 times the upper limit of normal (ULN) can be enrolled if total and direct bilirubin are normal. Patients with mildly elevated ALP (up to 1.5 x ULN) can be enrolled if cholestatic liver disease is excluded and no cause other than fatty liver is diagnosed. Patients with Gilbert's syndrome with elevated total bilirubin may be enrolled as long as direct bilirubin, hemoglobin and reticulocytes are normal.
Subject has creatinine > 1.5 x ULN; or estimated glomerular filtration rate using the Modification of Diet in Renal Disease formula ≤ 59 mL/min per 1.73 m^2 at the screening visit.
Subject has a history of suicide attempt or suicidal behavior within the last 12 months or has suicidal ideation within the last 12 months (a response of "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale [C-SSRS]), or who is at significant risk to commit suicide, as assessed at screening and at the time of visit 2 (randomization).
Subject has previously been enrolled in a clinical trial with fezolinetant.
Subject is participating concurrently in another interventional study or participated in an interventional study within 28 days prior to screening, or received any investigational drug within 28 days or within 5 half-lives prior to screening, whichever is longer.
Subject is unable or unwilling to complete the study procedures.
Subject has any condition which makes the subject unsuitable for study participation.
Subject has had a partial or full hysterectomy.

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

1831

Study ID:

NCT04003389

Recruitment Status:

Completed

Sponsor:

Astellas Pharma Global Development, Inc.

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There are 172 Locations for this study

See Locations Near You

SEC Clinical Research
Andalusia Alabama, 36420, United States
Alabama Clinical Therapeutics, LLC
Birmingham Alabama, 35205, United States
Alabama Clinical Therapeutics, LLC
Birmingham Alabama, 35235, United States
Achieve Clinical Research, LLC
Ensley Alabama, 35218, United States
Mesa Obstetricians and Gynecologists
Mesa Arizona, 85209, United States
Medpharmics LLC
Phoenix Arizona, 85015, United States
Precision Trials
Phoenix Arizona, 85032, United States
Del Sol Research Management
Tucson Arizona, 85712, United States
Visions Clinical Research - Tuscon
Tucson Arizona, 85712, United States
Eclipse Clinical Research
Tucson Arizona, 85745, United States
Hope Research Institute
Canoga Park California, 91303, United States
Alliance Research Inc
Canoga Park California, 91304, United States
Marvel Clinical Research
Huntington Beach California, 92647, United States
Grossmont Center for Clinical Research
La Mesa California, 91942, United States
Downtown L.A. Research Center, Inc.
Los Angeles California, 90017, United States
National Research Institute - Panorama
Los Angeles California, 90057, United States
Excell Research
Oceanside California, 92056, United States
Clinical Trials Research
Sacramento California, 95821, United States
Northern California Research
Sacramento California, 95821, United States
Wake Research Associates, LLC
San Diego California, 92108, United States
Women's Healthcare Affiliates
San Diego California, 92111, United States
CITrials, Inc
Santa Ana California, 92705, United States
Millennium Clinical Trials
Thousand Oaks California, 91360, United States
Women's Medical Group of Upland
Upland California, 91786, United States
Bayview Research Group
Valley Village California, 91607, United States
Downtown Women's Health Care
Denver Colorado, 80209, United States
Horizons Clincial Research Center LLC
Denver Colorado, 80220, United States
Coastal Connecticut Research, LLC
New London Connecticut, 06320, United States
Emerson Clinical Research institute
Washington District of Columbia, 20011, United States
Olympian Clinical Research
Clearwater Florida, 33757, United States
Precision Clinical Research
Coral Springs Florida, 33065, United States
Nature Coast Clinical Research
Crystal River Florida, 34429, United States
Avail Clinical Research, LLC
DeLand Florida, 32720, United States
Universal Axon Clinical Research
Doral Florida, 33166, United States
Fleming Island Center for Clinical Research
Fleming Island Florida, 32003, United States
Clinical Physiology Associates
Fort Myers Florida, 33912, United States
Florida Medical Research
Gainesville Florida, 32607, United States
Vital Pharma Research Inc.
Hialeah Florida, 33016, United States
Health Awareness
Jupiter Florida, 33458, United States
Multi-Specialty Research Associates, Inc.
Lake City Florida, 32055, United States
Altus Research
Lake Worth Florida, 33461, United States
LCC Medical Research Institute, LLC
Miami Florida, 33126, United States
Medical Research Center of Miami II
Miami Florida, 33134, United States
Medical Research Centers of South Florida, Inc.
Miami Florida, 33144, United States
Florida International Research Center
Miami Florida, 33174, United States
Spotlight research center
Miami Florida, 33176, United States
Med Research Of Florida, LLC
Miami Florida, 33186, United States
New Age Medical Research Corporation
Miami Florida, 33186, United States
Suncoast Clinical Research, Inc.
New Port Richey Florida, 34652, United States
Healthcare Clinical Data Inc
North Miami Florida, 33161, United States
Sensible Healthcare LLC
Ocoee Florida, 34761, United States
Bioclinica Research
Orlando Florida, 32806, United States
Clinical Neuroscience Solutions, Inc
Orlando Florida, 32806, United States
Omega Research Consultants
Orlando Florida, 32808, United States
Cornerstone Research Institute
Orlando Florida, 32822, United States
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach Florida, 32174, United States
Sunset Point Medical Associates
Palm Harbor Florida, 34684, United States
Radiant Research
Pinellas Park Florida, 33781, United States
St. Johns Center for Clinical Research
Ponte Vedra Florida, 32081, United States
Progressive Medical Research
Port Orange Florida, 32127, United States
Health Awareness
Port Saint Lucie Florida, 34952, United States
Precision Clinical Research
Sunrise Florida, 33351, United States
GCP Clinical Research, LLC
Tampa Florida, 33614, United States
Premier Medical Associates
The Villages Florida, 32159, United States
Clinical Research of Central Florida
Winter Haven Florida, 33880, United States
Agile Clinical Research Trials, LLC
Atlanta Georgia, 30328, United States
iResearch Atlanta LLC
Decatur Georgia, 30030, United States
NuDirections Clinical Research
Duluth Georgia, 30096, United States
Infinite Clinical Trials
Riverdale Georgia, 30274, United States
WR-Mount Vernon Clinical Research
Sandy Springs Georgia, 30328, United States
Georgia Clinical Research
Snellville Georgia, 30078, United States
Rosemark Women Care Specialists
Idaho Falls Idaho, 83404, United States
The Healing Sanctuary, LLC
Idaho Falls Idaho, 83404, United States
Womens Health USA, Inc.
Champaign Illinois, 61820, United States
Affinity Clinical Research Institute
Oak Brook Illinois, 60523, United States
Investigators Research Group, Llc
Brownsburg Indiana, 46254, United States
MediSphere Medical Research
Evansville Indiana, 47714, United States
Cypress Medical Research Center
Wichita Kansas, 67226, United States
Avant Research Associates, LLC
Crowley Louisiana, 70526, United States
Praetorian Pharmaceutical Research
Marrero Louisiana, 70072, United States
Southern Clinical Research Associates
Metairie Louisiana, 70001, United States
Medpharmics, LLC
Metairie Louisiana, 70006, United States
Pharmasite Research Inc
Baltimore Maryland, 21208, United States
Bay State Clinical Trials, Inc.
Watertown Massachusetts, 02472, United States
Saginaw Valley Medical Research Group, Llc
Saginaw Michigan, 48604, United States
Montana Medical Research Inc
Missoula Montana, 59801, United States
Quality Clinical Research, Inc
Omaha Nebraska, 68114, United States
Clinical Research Center of Nevada (CRCN)
Las Vegas Nevada, 89104, United States
Excel Clinical Research, LLC
Las Vegas Nevada, 89109, United States
Office Of Edmond Pack, Md
Las Vegas Nevada, 89113, United States
Dr.R. Garn Mabey, MD,Office Of
Las Vegas Nevada, 89128, United States
Hassman Research Institute, LLC
Berlin New Jersey, 08009, United States
Lawrence OBGYN Associates
Lawrenceville New Jersey, 08648, United States
Albuquerque Clinical Trials, Inc.
Albuquerque New Mexico, 87102, United States
Bosque Women's Care
Albuquerque New Mexico, 87109, United States
Rochester Clinical Research, Inc.
Rochester New York, 14609, United States
Circuit Clinical
West Seneca New York, 14224, United States
Upstate Clinical Research Associates LLC
Williamsville New York, 14221, United States
OnSite Clinical Solutions, LLC
Charlotte North Carolina, 28277, United States
Carolina women's research and wellness center
Durham North Carolina, 27714, United States
Carolina Insitute for Clinical Research
Fayetteville North Carolina, 28304, United States
Unified Women's Clinical Research
Greensboro North Carolina, 27408, United States
PMG Research of Hickory, LLC
Hickory North Carolina, 28601, United States
Unified Women's Clinical Research
Raleigh North Carolina, 27607, United States
Wake Research Associates, LLC
Raleigh North Carolina, 27612, United States
Unified Women's Clinical Research
Winston-Salem North Carolina, 27103, United States
Lillestol Research, LLC
Fargo North Dakota, 58104, United States
CTI
Cincinnati Ohio, 45227, United States
Greater Cincinnati OB/GYN
Cincinnati Ohio, 45267, United States
Aventiv Research, Inc.
Columbus Ohio, 43213, United States
Complete Healthcare For Women
Columbus Ohio, 43231, United States
Hwc Women's Research Center
Englewood Ohio, 45322, United States
Neuro-Behavioral Clinical Research, Inc
North Canton Ohio, 44720, United States
OB-GYN Associates
Erie Pennsylvania, 16507, United States
The Clinical Trial Center LLC
Jenkintown Pennsylvania, 19046, United States
Philadelphia Clinical Research, LLC
Philadelphia Pennsylvania, 19114, United States
Frontier Clinical Research
Smithfield Pennsylvania, 15478, United States
Clinical Trials of South Carolina
Charleston South Carolina, 29406, United States
Coastal Carolina Research Center
Mount Pleasant South Carolina, 29464, United States
Chattanooga GYN-Oncology
Chattanooga Tennessee, 37404, United States
WR Clinsearch, LLC
Chattanooga Tennessee, 37421, United States
Clinical Neuroscience Solutions, Inc
Memphis Tennessee, 38119, United States
Medical Research Center of Memphis, LLC
Memphis Tennessee, 38120, United States
International Clinical Research
Murfreesboro Tennessee, 37130, United States
Tekton Research - Georgetown
Austin Texas, 78745, United States
Gadolin Research, LLC
Beaumont Texas, 77702, United States
DiscoveResarch, Inc.
Bryan Texas, 77802, United States
Advances in Health
Houston Texas, 77030, United States
Centex Studies, Inc.
Houston Texas, 77058, United States
Protenium Clinical Research, LLC
Hurst Texas, 76054, United States
FMC Science
Lampasas Texas, 76550, United States
ClinRx Research
Plano Texas, 75024, United States
Clinical Trials of Texas
San Antonio Texas, 78229, United States
Northeast Clinical Research Centers, Inc.
Schertz Texas, 78154, United States
Excel Clinical Research, LLC
Sugar Land Texas, 77478, United States
EPIC Medical Research
Murray Utah, 84123, United States
Advanced Clinical Research-Old Farm OB/GYN (Utah)
Salt Lake City Utah, 84107, United States
Wasatch Clinical Research, LLC
Salt Lake City Utah, 84107, United States
Charlottesville Medical Research
Charlottesville Virginia, 22911, United States
Health Research of Hampton Roads Inc
Newport News Virginia, 23606, United States
Tidewater Clinical Research, Inc.
Virginia Beach Virginia, 23456, United States
Seattle Women's: Health, Research, Gynecology
Seattle Washington, 98115, United States
Site CA15005
Brampton Ontario, L6T 0, Canada
Site CA15006
Burlington Ontario, L7M 4, Canada
Site CA15010
Sarnia Ontario, N7T 4, Canada
Site CA15007
Toronto Ontario, M9W 4, Canada
Site CA15012
Levis Quebec, , Canada
Site CA15004
Point Claire Quebec, H9R 4, Canada
Site CA15003
Sherbrooke Quebec, J1L 0, Canada
Site CA15001
Victoriaville Quebec, G6P 6, Canada
Site CA15002
Quebec , G1N 4, Canada
Site CA15009
Quebec , G1W 4, Canada
Site CZ42008
Vodnany Jihocesky, 389 0, Czechia
Site CZ42001
Olomouc , 772 0, Czechia
Site CZ42003
Olomouc , 779 0, Czechia
Site CZ42010
Pisek , 39701, Czechia
Site CZ42009
Praha 2 , 12000, Czechia
Site CZ42005
Tabor 3 , 39003, Czechia
Site LV37102
Riga , 1005, Latvia
Site LV37101
Riga , 1010, Latvia
Site PL48004
Bialystok , 15-22, Poland
Site PL48005
Bydgoszcz , 85-06, Poland
Site PL48002
Katowice , 40-61, Poland
Site PL48019
Katowice , 40-85, Poland
Site PL48006
Lublin , 20-06, Poland
Site PL48014
Lublin , 20362, Poland
Site PL48016
Poznan , 60-19, Poland
Site PL48010
Szczecin , 71-43, Poland
Site PL48020
Warsaw , 02-20, Poland
Site PL48003
Warszawa , 02-79, Poland
Site PL48007
Warszawa , 02777, Poland
Site ES34005
Centelles , 08540, Spain
Site ES34002
Madrid , 28041, Spain
Site UA38004
Zaporizhzhya Zaporizka Oblast, 69065, Ukraine
Site UA38006
Kiev , , Ukraine
Site GB44003
Wokingham Berkshire, RG40 , United Kingdom
Site GB44008
Sidcup Kent, DA146, United Kingdom
Site GB44005
Corby Northamptonshire, NN17 , United Kingdom
Site GB44004
Kenilworth Warwickshire, CV8 1, United Kingdom
Site GB44006
Middlesex , HA6 2, United Kingdom
Site GB44007
Romford , , United Kingdom
Site GB44001
Shipley , BD18 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

1831

Study ID:

NCT04003389

Recruitment Status:

Completed

Sponsor:


Astellas Pharma Global Development, Inc.

How clear is this clinincal trial information?

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