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Trial Title:
A Study to Evaluate Ethanol-induced Symptoms and Safety in Breast Cancer Patients
NCT ID:
NCT06537752
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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
Criteria for eligibility:
Study pop:
Breast cancer patients in need of neoadjuvant/adjuvant chemotherapy including Non-ethanol
formulation docetaxel before and after surgery
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Gender based:
Yes
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chung-Ang University Hospital
Address:
City:
Seoul
Zip:
06973
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Min Kyoon Kim
Facility:
Name:
Uijeongbu Eulji Medical Center, Eulji University
Address:
City:
Uijeongbu
Zip:
11759
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Byung Joo Song
Start date:
July 15, 2024
Completion date:
October 2026
Lead sponsor:
Agency:
Boryung Pharmaceutical Co., Ltd
Agency class:
Industry
Source:
Boryung Pharmaceutical Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06537752
