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

NCT06537752 | Recruiting

• 1 other identifier: BR-DTX-OS-402
• Study Type: observational
• Target: 1,052
• Locations: 1 country
• Sites: 2

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of ethanol-induced symptoms in the initial cycle

  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.

  From the time of treatment started until the end of follow-up(30 minutes after the treatment)

Eligibility Criteria

• Age: 19 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients in need of neoadjuvant/adjuvant chemotherapy including Non-ethanol formulation docetaxel before and after surgery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (2)

Chung-Ang University Hospital

Seoul, 06973, South Korea

RECRUITING

Uijeongbu Eulji Medical Center, Eulji University

Uijeongbu-si, 11759, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Shin-young Oh

CONTACT

+82-2-708-8000; syoh@boryung.co.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

KR (2)