A Study to Evaluate Ethanol-induced Symptoms and Safety in Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 19 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
Primary outcome measures
- 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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 2 centers
- Chung-Ang University Hospital — Seoul
- Uijeongbu Eulji Medical Center, Eulji University — Uijeongbu-si
Identifiers
NCT: NCT06537752 · BR-DTX-OS-402