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A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women with Breast Cancer Who Are Having Hormone Therapy
EU CTIS ID: 2024-510719-31-00
What this study is testing
To evaluate the efficacy of fezolinetant 45 mg once daily versus placebo on frequency and severity of moderate to severe VMS in women experiencing VMS due to adjuvant endocrine therapy for stage 0-3 hormone receptor-positive (HR+) breast cancer.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant is born female, and at least 18 years of age at the time of signing the informed consent form (ICF).
- Participant has a personal history of stage 0-3 HR+, either human epidermal growth factor receptor-2 postitive (HER-2+) or HER-2 negative (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 (CDK)-4 inhibitors) are allowed.
- Participant has a minimum average of 7 moderate to severe 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 Eastern Cooperative Oncology Group (ECOG) score 0 or 1.
- Has at least 12-month life expectation.
You likely can't join if
- 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 alanine or aspartate aminotransferases (ALT or 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 m^2 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.
See the full eligibility criteria
Who can join
- Participant is born female, and at least 18 years of age at the time of signing the informed consent form (ICF).
- Participant has a personal history of stage 0-3 HR+, either human epidermal growth factor receptor-2 postitive (HER-2+) or HER-2 negative (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 (CDK)-4 inhibitors) are allowed.
- Participant has a minimum average of 7 moderate to severe 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 Eastern Cooperative Oncology Group (ECOG) score 0 or 1.
- Has at least 12-month life expectation.
- Participant has a negative serology panel (including hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody and human immunnodeficiency virus (HIV) antibody screens).
What rules you out
- 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 alanine or aspartate aminotransferases (ALT or 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 m^2 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.
- 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 Cytochrome P450 (CYP)1A2 inhibitors) or is not willing to wash out such drugs; in addition, investigators should consider medications that are contraindicated due to underlying breast cancer diagnosis and the adjuvant endocrine therapy.
- Participant has a known or suspected hypersensitivity to fezolinetant, the adjuvant endocrine therapy being used, or any components of the formulations used.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.