An observational study in Breast Cancer, sponsored by The First Affiliated Hospital with Nanjing Medical University. Status unknown at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-05-24.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational
This is a multicenter, observational, single-arm real world study to evaluate the efficacy and safety of pyrotinib after lapatinib progression.
HER2-positive breast cancers account for 15%-20% of all breast cancers. The development of HER2 targeted therapies have greatly improved the survival of HER2-positive breast cancer patients. Lapatinib has shown effectiveness in treating HER2-positive metastatic breast cancers, but therapies after lapatinib progression are still controversial. This study is aimed to evaluate the efficacy and safety of pyrotinib after lapatinib progression.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 100 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
Counted across the registry records on this site, refreshed daily.
HER2-positive metastatic breast cancer patients who failed by lapatinib received pyrotinib
Exclusion Criteria:
Patients receive pyrotinib-based therapy after lapatinib progression.
Drug: Pyrotinib
Pyrotinib-based therapy
Progression Free Survival (PFS)
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
Time frame: 2 years
Objective Response Rate (ORR)
The overall response rate is defined as the percentage of patients with a best overall response of CR or PR relative to the appropriate analysis set
Time frame: 2 years
The Number of Participants Who Experienced Adverse Events (AE)
Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).
Time frame: 2 years
Plan to share: No
This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital with Nanjing Medical University