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
Eligibility
Sex
FEMALE
Min age
19 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of ethanol-induced symptoms in the initial cycle — 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.
Trial sites (2)
Facility
City
Region
Status
Chung-Ang University Hospital
Seoul
South Korea
Recruiting
Uijeongbu Eulji Medical Center, Eulji University
Uijeongbu-si
South Korea
Not Yet Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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