TerminatedPhase 2

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

Stopped: Difficulty in recruiting breast cancer patients, leading to a slow rate of case enrollment.

Taiwan10 participantsStarted 2019-11-07

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 c…

What they're measuring

Mean change in frequency of moderate to severe VMS

Timeframe: 4, 12 weeks

Mean change in severity of moderate to severe VMS

Timeframe: 4, 12 weeks

Trial details

NCT IDNCT06161792

SponsorYung Shin Pharm. Ind. Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-14