-
JBCRG-16Pharm
Dual-HER2 blockage therapy ± hormone therapy in HER2-positive breast cancer (Randomized phase II trial: Neo-LaTH study) Cohort study
- Status
-
Study Closed
- Objectives
-
- Subjects
-
All breast cancer cases enrolled in the JBCRG-16 (Neo-LaTH) study conducted as an investigator-initiated clinical trial
- Endpoints
-
Primary Endpoints;
To compare the incidence of Grade 2 diarrhea or higher in patients who took lapatinib after fasting at night or after fasting at night and before sleep with that in patients who took lapatinib after meals other than before sleep.
Secondary Endpoints;
To compare the incidence of adverse events (Grade 2 or higher diarrhea and skin symptoms) in patients who took lapatinib after fasting at night or after fasting at night and before sleep with those who took lapatinib after meals other than before sleep.
Efficacy (pCR) of lapatinib taken after fasting at night or after fasting at night and before sleep will be compared with those taken after meals other than before sleep.
The treatment discontinuation rate of lapatinib post-night fasting or post-night fasting and pre-sleep will be compared with that of patients taking postprandial lapatinib other than pre-sleep.
- Trial Period
-
- Lead Principal Investigator
-
- Target Sample Size
-
213
- Regimen
-
- Source of Funding
-
Japan Breast Cancer Research Group
- Conference Presentation
-
- Articles and Publications
-
Overnight fasting before lapatinib administration to breast cancer patients leads to reduced toxicity compared with nighttime dosing: a retrospective cohort study from a randomized clinical trial
- UMIN-ID
-
- jRCT
-
- Memo
-
- COI Disclosure
-
