Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2026-01-01 @ 5:55 PM
Study NCT ID:
NCT06161792
Status:
TERMINATED
Last Update Posted:
2023-12-08
First Post:
2023-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate RCN3028 in Treatment of Drug-Induced VMS in Breast Cancer
Sponsor:
Yung Shin Pharm. Ind. Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Placebo-Controlled, Double-Blind, Parallel, Phase 2 Study to Evaluate the Efficacy and Safety of RCN3028 in Treatment of Drug-Induced Moderate to Severe Vasomotor Symptoms in Breast Cancer Subjects
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty in recruiting breast cancer patients, leading to a slow rate of case enrollment.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VMS
Brief Summary:
Due to the fact that majority of breast cancers are estrogen-receptor and/or progesterone receptor positive, tamoxifen and aromatase inhibitors (AIs) are among the mainstay therapies to treat breast cancer. Prior clinical studies of tamoxifen suggested that up to 80 % of patients experienced hot flashes during therapy with tamoxifen, and 30 % defined their symptoms as severe. Despite the high efficacy of tamoxifen, the harmful side effects have been identified in previous studies as a significant reason for not persisting with the treatment in 16 - 30 % of breast cancer patients.
The primary purpose of this study is to determine if RCN3028 is effective and safe in the treatment of moderate to severe vasomotor symptoms associated. In accordance with the latest FDA guidance study participants will have a minimum of 7 moderate to sever hot flashes per day, or 50 per week at baseline.
The primary purpose of this study is to determine if RCN3028 is effective and safe in the treatment of moderate to severe vasomotor symptoms associated. In accordance with the latest FDA guidance study participants will have a minimum of 7 moderate to sever hot flashes per day, or 50 per week at baseline.
Detailed Description:
Hot flashes are the most common symptom of menopause and affect almost 75% of menopausal women. Clinical evidence indicates potent antagonists of 5-HT2a are more likely to cause hypothermia. Risperidone is a potent 5-HT2a and a dopamine D2 receptor antagonist and is proposed to have effect on reduction of hot flashes through its dopaminergic and serotonergic antagonism.
Breast cancer is one of the most common cancers in women, according to the cancer registration report of the Ministry of Health and Welfare (MOHW), in 2014, up to 11,976 women suffered from breast cancer, which meant 33 women suffered from breast cancer daily. Recent epidemiology further disclosed that the incidence of breast cancer was top-ranked (70.74 per 100,000) among cancers of Taiwanese women in 2014.
Due to the fact that majority of breast cancers are estrogen-receptor and/or progesterone receptor positive, tamoxifen and aromatase inhibitors (AIs) are among the mainstay therapies to treat breast cancer. Prior clinical studies of tamoxifen suggested that up to 80 % of patients experienced hot flashes during therapy with tamoxifen, and 30 % defined their symptoms as severe. Despite the high efficacy of tamoxifen, the harmful side effects have been identified in previous studies as a significant reason for not persisting with the treatment in 16 - 30 % of breast cancer patients.
The primary purpose of this study is to determine if RCN3028 is effective and safe in the treatment of moderate to severe vasomotor symptoms associated. In accordance with the latest FDA guidance study participants will have a minimum of 7 moderate to sever hot flashes per day, or 50 per week at baseline.
With recent advances of treatment modalities, more than 80% of women with a newly diagnosed breast cancer are expected to survive their disease for 5 years or more. One of the most common complaints was hot flashes induced by the treatment of breast cancer (i.e., tamoxifen induced hot flashes).
In general, hormone replacement therapy (HRT) is the most effective treatment for VMS (hot flashes). However, HRT has been associated with increased risk of recurrence in breast cancer survivors . Moreover, there is some evidence that HRT may not be as effective in women using tamoxifen. Therefore, a new therapy for treating hot flashes in breast cancer patients without increasing the risk of cancer recurrence is needed for such patient population, for example, a non-hormonal therapy. FDA approved low-dose paroxetine capsules (Brisdelle®) as a non-hormonal therapy for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, despite the modest efficacy as compared with placebo, suicidal ideation and the drug-drug interactions (i.e., Brisdelle® and tamoxifen) . Brisdelle® itself is an antidepressant of selective serotonin reuptake inhibitors (SSRI) class. Several trials have recently demonstrated a role for SSRIs and serotonin-norepinephrine reuptake inhibitors (SNRIs) for the treatment of VMS.
Breast cancer is one of the most common cancers in women, according to the cancer registration report of the Ministry of Health and Welfare (MOHW), in 2014, up to 11,976 women suffered from breast cancer, which meant 33 women suffered from breast cancer daily. Recent epidemiology further disclosed that the incidence of breast cancer was top-ranked (70.74 per 100,000) among cancers of Taiwanese women in 2014.
Due to the fact that majority of breast cancers are estrogen-receptor and/or progesterone receptor positive, tamoxifen and aromatase inhibitors (AIs) are among the mainstay therapies to treat breast cancer. Prior clinical studies of tamoxifen suggested that up to 80 % of patients experienced hot flashes during therapy with tamoxifen, and 30 % defined their symptoms as severe. Despite the high efficacy of tamoxifen, the harmful side effects have been identified in previous studies as a significant reason for not persisting with the treatment in 16 - 30 % of breast cancer patients.
The primary purpose of this study is to determine if RCN3028 is effective and safe in the treatment of moderate to severe vasomotor symptoms associated. In accordance with the latest FDA guidance study participants will have a minimum of 7 moderate to sever hot flashes per day, or 50 per week at baseline.
With recent advances of treatment modalities, more than 80% of women with a newly diagnosed breast cancer are expected to survive their disease for 5 years or more. One of the most common complaints was hot flashes induced by the treatment of breast cancer (i.e., tamoxifen induced hot flashes).
In general, hormone replacement therapy (HRT) is the most effective treatment for VMS (hot flashes). However, HRT has been associated with increased risk of recurrence in breast cancer survivors . Moreover, there is some evidence that HRT may not be as effective in women using tamoxifen. Therefore, a new therapy for treating hot flashes in breast cancer patients without increasing the risk of cancer recurrence is needed for such patient population, for example, a non-hormonal therapy. FDA approved low-dose paroxetine capsules (Brisdelle®) as a non-hormonal therapy for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, despite the modest efficacy as compared with placebo, suicidal ideation and the drug-drug interactions (i.e., Brisdelle® and tamoxifen) . Brisdelle® itself is an antidepressant of selective serotonin reuptake inhibitors (SSRI) class. Several trials have recently demonstrated a role for SSRIs and serotonin-norepinephrine reuptake inhibitors (SNRIs) for the treatment of VMS.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: