Plain-English translation of NCT06254690 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Breast Cancer research guide →Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This trial is testing a medication called pyrotinib in women with advanced HER2-positive breast cancer. The study wants to see if gradually increasing the dose from a low starting point causes fewer side effects—especially severe diarrhea—compared to starting at the standard dose right away. Researchers will follow 102 women to compare how safe and effective each dosing approach is.
Pyrotinib can cause serious diarrhea in some patients, which may force them to stop taking the medication. This trial is testing whether starting with a lower dose and slowly increasing it might help patients tolerate the treatment better while still fighting their cancer effectively.
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If you join this study, you will be randomly assigned to take the medication by mouth once daily, either starting at a lower dose and gradually increasing it over three weeks, or starting at the standard dose right away. You will take the medication for multiple treatment cycles (each cycle is typically 3–4 weeks) and visit the clinic regularly so doctors can check for side effects, monitor how well the treatment is working, and do blood tests and imaging scans. The study will track your health, any side effects you experience, and how long you survive before your cancer progresses.
AI-generated summary from trial data · Jun 18, 2026 · Not medical advice
China
Phase
Testing effectiveness
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Zhongda Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Enrollment target
~102 participants
Started
January 2024
Primary completion
November 2026
Age range
18 Years – 70 Years
Sex
Female only
Last updated on clinicaltrials.gov in February 2024.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Yongmei Yin, Ph.D
The First Affiliated Hospital with Nanjing Medical University
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.