Evaluate RCN3028 in Treatment of Drug-Induced VMS in Breast Cancer

NCT06161792 | Terminated Phase 2

• 1 other identifier: YSP-RCN3028-03
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

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.

Conditions

Hot Flashes; Breast Cancer

Keywords

Hot Flashes

Outcome Measures

Primary Outcomes (2)

• Mean change in frequency of moderate to severe VMS

  Mean change in frequency numbers of moderate to severe VMS(Vasomotor Symptoms) from baseline to weeks 4 and week 12. The VMS episode event log recorded the frequency of hot flashes per day, such mild, moderate, severe, nighttime awakening number.

  4, 12 weeks

• Mean change in severity of moderate to severe VMS

  Mean change in severity score of moderate to severe VMS from baseline to weeks 4 and week 12. The severity score for VMS for each subject is calculated as the sum of 2 times the number of moderate VMS, plus 3 times the number of severe VMS, divided by the total number of moderate and severe VMS.

  4, 12 weeks

Secondary Outcomes (8)

• Menopause Specific Quality of Life Questionnaire

  12 weeks

• The 50%, 75% and 100% responder rates

  12 weeks

• The time to onset of efficacy

  12 weeks

• Subject's and Physician's Global Assessment

  12 weeks

• Frequencies(number and percentage) of subjects with treatment-emergent AEs (TEAEs)

  12 weeks

Study Arms (2)

I placebo capsule

PLACEBO COMPARATOR

Subjects will be enrolled to about 14-days of placebo-run-in period. Other Names: RCN3028 placebo

Drug: Placebo

II RCN3028 0.8 mg capsule

EXPERIMENTAL

Subjects will be enrolled to about 14-days of placebo-run-in period. Treatment started at 0.4 mg, titrated to 0.8 mg for maintenance phase. Other Names: RCN3028 0.8 mg capsule

Drug: 0.8 mg RCN3028

Interventions

0.8 mg RCN3028 DRUG

Oral

II RCN3028 0.8 mg capsule

Placebo DRUG

Oral

I placebo capsule

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects (aged 20 years or order) with confirmed diagnosis of breast cancer who have completed chemotherapy and radiotherapy, and are on a stable dose of tamoxifen or aromatase inhibitors (AIs) for at least 8 weeks at baseline and will maintain the same treatment regimen and dose throughout the study.
• Reported 7 or more moderate to severe hot flashes per day (average) or 50 moderate to severe hot flashes per week at baseline.
• Screening laboratory values for hematopoietic, hepatic, and renal functions are within the following ranges:
• Hematopoietic : Absolute neutrophil count ≥ 1,500/mm3、Platelet count ≥ 100,000/mm3
• Hepatic : Glutamic Oxaloacetic Transaminase/Glutamic Pyruvic Transaminase ≤ 3 times upper limit of normal (ULN)、Bilirubin ≤ 1.5 times ULN
• Renal : Creatinine ≤ 1.5 times ULN
• Having Eastern Collaborative Oncology Group (ECOG) Performance Status of ≤ 1.
• Ability to understand and follow the instructions of the investigator, including completion of the study procedures as described in the protocol (i.e., VMS episode event log).
• Able and willing to provide written informed consent.

You may not qualify if:

• Subjects are pregnant or breastfeeding.
• Female subjects who have childbearing potential, but they are not willing to use effective contraceptive methods during study period and for 1 week afterward.
• Subjects who have multiple primary cancers (except for completely resected basal cell cancer, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial bladder cancer or any other cancer from which the patient has been recurrence-free for at least 5 years).
• Subjects who have inoperable breast cancer (Stage IIIB/IIIC/IV).
• Subjects who have the following medical history: myocardial infarction, congestive heart failure, significant ischemic or valvular heart disease, clinically active interstitial lung disease.
• Subjects who have systolic blood pressure (BP) outside the range 100 to 150 mmHg, diastolic BP outside the range 60 to 90 mmHg, and/or heart rate outside the range 50 to 100 bpm at baseline.
• Subjects who had received treatment for hypotension within 30 days prior to screening visit.
• Subjects who have uncontrolled hyperglycemia, HbA1c ≥ 7% at baseline.
• Subjects who have clinical significant conditions such as acute myocardial infarction or stroke with 6 months of randomization.
• Subjects who have a history of Parkinson's disease.
• Subjects are taking risperidone in the 30 days prior to screening visit.
• Subjects who had participated in another clinical trial and received an investigational drug within 30 days prior to screening visit.
• Subjects having a known history of allergic reaction, hypersensitivity or clinically significant intolerance to ingredients of the study drug.
• Subjects with a current drug or alcohol abuse problem as judged by the investigator.
• Subjects who use Selective Serotonin Reuptake Inhibitors (SSRI) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRI), within 4 weeks prior to screening visit.

Sponsors & Collaborators

• Yung Shin Pharm. Ind. Co., Ltd.: lead

Study Sites (4)

Changhua Christain Hospital

Changhua, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Taipei Medical University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hot Flashes; Breast Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• hui-Ling Shieh, PhD

  Yung Shin Pharm. Ind. Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: December 8, 2023
• Study Start: November 7, 2019
• Primary Completion: March 14, 2022
• Study Completion: April 20, 2022
• Last Updated: December 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (4)