A Study to Evaluate Ethanol-induced Symptoms and Safety in Breast Cancer Patients

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06537752
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief Summary

The purpose of this study is to evaluate ethanol-induced symptoms and safety in breast cancer patients with neoadjuvant/adjuvant chemotherapy including Non-ethanol formulation docetaxel before and after surgery

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-15
• Study First Submitted: 2024-07-31
• Study First Submitted QC: 2024-07-31
• Last Update Submitted: 2024-07-31
• Study First Posted: 2024-08-05
• Last Update Posted: 2024-08-05
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1052

Inclusion Criteria

• Those who voluntarily signed a written personal information collection and usage agreement after receiving an explanation about the objective and method, etc. of this clinical study.

• Those are confirmed to have primary breast cancers through histological diagnosis and one of the following are applicable.

  • Those who need neoadjuvant chemotherapy as breast cancer patients
  • Those who need adjuvant chemotherapy after breast cancer surgery

• Those who are scheduled to administer non-ethanol formulation docetaxel according to chemotherapy

• Those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion.

Exclusion Criteria

• Those are diagnosed with other primary cancer that can influence the treatment or prognosis of primary breast cancers.
• Those are diagnosed with secondary breast cancers.
• Those with Stage 0/1 (Tis, N0, M0) or Stage IV (any T, Any N, M1) breast cancers.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of ethanol-induced symptoms in the initial cycle	From the time of treatment started until the end of follow-up(30 minutes after the treatment)	This outcome's definition is an increase from baseline in the number of ethanol-induced symptoms during or within 30 minutes after the treatment. The initial cycle of non-ethanol formulation docetaxel is collected as 1 cycle.

Trial Locations

Locations (2)

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Uijeongbu Eulji Medical Center, Eulji University; 🇰🇷 Uijeongbu, Korea, Republic of