Neoadjuvant Pyrotinib-to-pertuzumab in HER2+ eBC
Sponsor: Shanghai Jiao Tong University School of Medicine • ClinicalTrials.gov ID: NCT07797218
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This is a randomized, open-label, superiority, multicenter clinical trial for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer. It aims to compare the efficacy of neoadjuvant treatment with 2 cycles of Pyrotinib + Trastuzumab + Docetaxel followed by 2 cycles of Pertuzumab + Trastuzumab + Docetaxel versus 4 cycles of Pertuzumab + Trastuzumab + Docetaxel. Exploratory analyses of ctDNA clearance rate and MRI response will also be conducted.
Interventions
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Docetaxel
(Drug)
docetaxel ivgtt q3w, 80-100mg/m2
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Pyrotinib
(Drug)
pyrotinib 320mg p.o. qd
-
Trastuzumab (Herceptin)
(Drug)
trastuzumab ivgtt q3w, 8mg/kg for initiation, 6mg/kg for maintenance, or 600mg sc q3w
-
Pertuzumab
(Drug)
pertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance
Eligibility criteria
Conditions
Locations
- Ruijin Hospital — Shanghai, China
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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