Breast Cancer
Conditions
Brief 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
Interventions
None listed
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Contacts
Primary ContactShin-young Oh
Outcome results
None listed