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

NCT06161792 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-12-08

No results posted yet for this study

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

Interventions

DRUG

0.8 mg RCN3028

Oral

DRUG

Placebo

Oral

Sponsors & Collaborators

  • Yung Shin Pharm. Ind. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • hui-Ling Shieh, PhD · Yung Shin Pharm. Ind. Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-07
Primary Completion
2022-03-14
Completion
2022-04-20

Countries

  • Taiwan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06161792 on ClinicalTrials.gov