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

September 10, 2025 updated by: Boryung Pharmaceutical Co., Ltd

A Multi-center, Prospective, Observational stuDy to Evaluate EThanOl-induced Symptoms and Safety in Breast Cancer Patients witH Neoadjuvant/Adjuvant Chemotherapy Including Non-ethanol Formulation Docetaxel Before and After Surgery

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1052

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Seoul, South Korea, 06973
        • Recruiting
        • Chung-Ang University Hospital
        • Contact:
          • Min Kyoon Kim
      • Uijeongbu-si, South Korea, 11759
        • Not yet recruiting
        • Uijeongbu Eulji Medical Center, Eulji University
        • Contact:
          • Byung Joo Song

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of ethanol-induced symptoms in the initial cycle
Time Frame: 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.
From the time of treatment started until the end of follow-up(30 minutes after the treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boryung Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

July 31, 2024

First Submitted That Met QC Criteria

July 31, 2024

First Posted (Actual)

August 5, 2024

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-DTX-OS-402

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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