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NCT Number: NCT06537752

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

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

Recruiting

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Chung-Ang University Hospital, Seoul, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shin-young Oh

CONTACT

[email protected]

+82-2-708-8000

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2024
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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