Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer
Recruiting
Phase 2Interventional Study
Advanced Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
186 (estimated)
Sponsor
Wenjin Yin · Other
Who this trial is looking for
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This is a prospective, randomised, controlled, multicentre study to evaluate the efficacy and safety of continuous versus intermittent pyrotinib therapy in patients with human epidermal growth factor receptor (HER2)-positive advanced breast cancer.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Age≥18 years old
* Pathologically confirmed advanced or locally advanced breast cancer not amenable to curative surgery
* Pathologically confirmed HER2+ at least once for either primary or metastatic lesion
* Previously treated with any number of lines for advanced disease and…
Inclusion Criteria:
* Age≥18 years old
* Pathologically confirmed advanced or locally advanced breast cancer not amenable to curative surgery
* Pathologically confirmed HER2+ at least once for either primary or metastatic lesion
* Previously treated with any number of lines for advanced disease and eligible for a pyrotinib-containing regimen at the discretion of physician
* At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1
* ECOG 0-1
* Adequate organ function
Exclusion Criteria:
* During pregnancy and lactation
* Difficulties with pyrotinib administration or absorption
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