A Study to Evaluate Ethanol-induced Symptoms and Safety i... | NCT06537752

Studies
A Study to Evaluate Ethanol-induced Symptoms and Safety in Breast Cancer Patients

NCT06537752

Sponsor

Boryung Pharmaceutical Co., Ltd

Status

Recruiting

Last Update Posted

Sep 12, 2025Actual

Enrollment

1,052Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2024Actual

Primary Completion Date

Oct 2026Estimated

Completion Date

Oct 2026Estimated

First Submitted Date

Jul 31, 2024

First Submission Date that Met QC Criteria

Jul 31, 2024

First Posted Date

Aug 5, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2025

Last Update Posted Date

Sep 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,052Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	From the time of treatment started until the end of follow-up(30 minutes after the treatment)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Breast cancer patients in need of neoadjuvant/adjuvant chemotherapy including Non-ethanol formulation docetaxel before and after surgery

Sampling Method

Non-Probability Sample

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases