Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440967
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-29
Brief Title:
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy
Sponsor:
Astellas Pharma Global Development Inc
Organization:
Astellas Pharma Inc
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 doesnt 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
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 Some women may be able to use the app on their own smartphone In the last 10 days before their next clinic visit the women will record information about their hot flashes 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 This will include some blood and urine tests The last clinic visit will be 3 weeks after the women take their last tablet of study treatment fezolinetant or placebo
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
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 Some women may be able to use the app on their own smartphone In the last 10 days before their next clinic visit the women will record information about their hot flashes 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 This will include some blood and urine tests The last clinic visit will be 3 weeks after the women take their last tablet of study treatment fezolinetant or placebo
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None