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

NCT ID: NCT06537752

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1052 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-15

Study Completion Date

2026-10-31

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chung-Ang University Hospital

Seoul, , South Korea

Site Status RECRUITING

Uijeongbu Eulji Medical Center, Eulji University

Uijeongbu-si, , South Korea

Site Status NOT_YET_RECRUITING

Countries

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South Korea

Central Contacts

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Shin-young Oh

Role: CONTACT

+82-2-708-8000

Facility Contacts

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Min Kyoon Kim

Role: primary

Byung Joo Song

Role: primary

Other Identifiers

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BR-DTX-OS-402

Identifier Type: -

Identifier Source: org_study_id

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