A Study to Evaluate Ethanol-induced Symptoms and Safety in Breast Cancer Patients
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age19+
SponsorBoryung Pharmaceutical Co., Ltd
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Breast cancer patients in need of neoadjuvant/adjuvant chemotherapy including Non-ethanol formulation docetaxel before and after surgery
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Incidence of ethanol-induced symptoms in the initial cycle
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.
Time frame
From the time of treatment started until the end of follow-up(30 minutes after the treatment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov