Ignite Creation Date:
2024-05-06 @ 6:12 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05587296
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2022-10-17
Brief Title:
A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With or at High Risk for Developing Hormone-receptor Positive Breast Cancer
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Double-blind Randomized Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Induced by Adjuvant Endocrine Therapy Over 52 Weeks and Optionally for Additional 2 Years in Women With Hormone-receptor Positive Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
OASIS-4
Brief Summary:
Researchers are looking for a better way to treat women with or at high risk for developing hormone-receptor positive breast cancer who have vasomotor symptoms VMS a condition of having hot flashes caused by anti-cancer therapy
VMS also called hot flashes are very common medical problems in women with hormone-receptor HR-positive breast cancer who are receiving anti-cancer therapy HR-positive breast cancer is a type of breast cancer which has hormone-receptors proteins for female sex hormones estrogen andor progesterone These hormone-receptors may attach to hormones like estrogen and progesterone and thereby help cancer cells to grow and to spread Treatments that stop these hormones from attaching to these receptors are currently used to slow or stop the growth of HR-positive breast cancer
It is already known that women with HR-positive breast cancer benefit from this treatment However hot flashes are common medical problems related to this therapy They negatively affect quality of life of many women and may lead to discontinuation stopping of this therapy
The study treatment elinzanetant is being developed to treat hot flushes It works by blocking a substance called neurokinin from sending signals to other parts of the body which is thought to play a role in starting hot flashes
The main purpose of this study is to learn more about how well elinzanetant helps to treat hot flashes caused by anti-cancer therapy in women with or at high risk for developing HR-positive breast cancer compared to placebo A placebo is a treatment that looks like a medicine but does not have any medicine in it
To answer this the doctors will ask the participants to record information about their hot flashes before treatment start and at certain time points during the treatment in an electronic diary The researchers will then assess possible average changes in number and severity of hot flashes after 4 and 12 weeks of treatment
To see how safe elinzanetant is compared to placebo The study will collect information about the number of participants who have medical problems after taking treatment
The study participants will be randomly by chance assigned to 2 treatment groups A and B The participants from treatment group A will take elinzanetant The participants from treatment group B will start with placebo and then switch to elinzanetant
All participants will continue taking the anti-cancer therapy they have been using when entering the study
Dependent on the treatment group the participants will either take elinzanetant or placebo as capsules by mouth once a day After 12 weeks the participants who have initially received placebo will switch to take elinzanetant for the remaining 40 weeks
Each participant will be in the study for approximately 62 weeks The treatment duration in the study will be 52 weeks There will be up to 12 visits to the study site and 6 phone calls in between Participants who completed the 52 weeks treatment phase will be offered to continue treatment for another 2 years Visit frequency every 24 weeks until week 152
During the study the participants will
record information about their hot flashes
answer questions about their quality of life and other symptoms
The doctors and their study team will
check the participants health and vital signs
take blood and urine samples
examine heart health using electrocardiogram ECG
examine pelvic organs like womb or ovaries using a trans vaginal ultrasound scan to see images of these organs
make images of the breast using x-ray mammogram a type of radiation that passes through the body to make images of the inside andor by using ultrasound if applicable
check the health of the participants cervix neck of the womb by taking a small sample of cells smear test for an analysis called cervical cytology if applicable
take an endometrial biopsy a small piece of tissue from the lining of the womb called the endometrium for analysis
ask the participants questions about what medicines they are taking and if they are having adverse events
An adverse event is any medical problem that a participant has during a study Doctors keep track of all adverse events that happen in studies even if they do not think the adverse events might be related to the study treatments
About 4 weeks after the participants take their last treatment the study doctors and their team will check the participants health
VMS also called hot flashes are very common medical problems in women with hormone-receptor HR-positive breast cancer who are receiving anti-cancer therapy HR-positive breast cancer is a type of breast cancer which has hormone-receptors proteins for female sex hormones estrogen andor progesterone These hormone-receptors may attach to hormones like estrogen and progesterone and thereby help cancer cells to grow and to spread Treatments that stop these hormones from attaching to these receptors are currently used to slow or stop the growth of HR-positive breast cancer
It is already known that women with HR-positive breast cancer benefit from this treatment However hot flashes are common medical problems related to this therapy They negatively affect quality of life of many women and may lead to discontinuation stopping of this therapy
The study treatment elinzanetant is being developed to treat hot flushes It works by blocking a substance called neurokinin from sending signals to other parts of the body which is thought to play a role in starting hot flashes
The main purpose of this study is to learn more about how well elinzanetant helps to treat hot flashes caused by anti-cancer therapy in women with or at high risk for developing HR-positive breast cancer compared to placebo A placebo is a treatment that looks like a medicine but does not have any medicine in it
To answer this the doctors will ask the participants to record information about their hot flashes before treatment start and at certain time points during the treatment in an electronic diary The researchers will then assess possible average changes in number and severity of hot flashes after 4 and 12 weeks of treatment
To see how safe elinzanetant is compared to placebo The study will collect information about the number of participants who have medical problems after taking treatment
The study participants will be randomly by chance assigned to 2 treatment groups A and B The participants from treatment group A will take elinzanetant The participants from treatment group B will start with placebo and then switch to elinzanetant
All participants will continue taking the anti-cancer therapy they have been using when entering the study
Dependent on the treatment group the participants will either take elinzanetant or placebo as capsules by mouth once a day After 12 weeks the participants who have initially received placebo will switch to take elinzanetant for the remaining 40 weeks
Each participant will be in the study for approximately 62 weeks The treatment duration in the study will be 52 weeks There will be up to 12 visits to the study site and 6 phone calls in between Participants who completed the 52 weeks treatment phase will be offered to continue treatment for another 2 years Visit frequency every 24 weeks until week 152
During the study the participants will
record information about their hot flashes
answer questions about their quality of life and other symptoms
The doctors and their study team will
check the participants health and vital signs
take blood and urine samples
examine heart health using electrocardiogram ECG
examine pelvic organs like womb or ovaries using a trans vaginal ultrasound scan to see images of these organs
make images of the breast using x-ray mammogram a type of radiation that passes through the body to make images of the inside andor by using ultrasound if applicable
check the health of the participants cervix neck of the womb by taking a small sample of cells smear test for an analysis called cervical cytology if applicable
take an endometrial biopsy a small piece of tissue from the lining of the womb called the endometrium for analysis
ask the participants questions about what medicines they are taking and if they are having adverse events
An adverse event is any medical problem that a participant has during a study Doctors keep track of all adverse events that happen in studies even if they do not think the adverse events might be related to the study treatments
About 4 weeks after the participants take their last treatment the study doctors and their team will check the participants health
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-000095-18 | EUDRACT_NUMBER | CTIS EU | None |
| 2023-508265-33-00 | REGISTRY | None | None |