Status:
UNKNOWN
Neoadjuvant Treatment With Palbociclib and Exemestane Plus Trastuzumab and Pyrotinib in Estrogen Receptor (ER)-Positive, HER2-positive Breast Cancer
Lead Sponsor:
Guangdong Provincial People's Hospital
Conditions:
Neoadjuvant Treatment for HER2-positive, ER-positive Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
neoPEHP is a multicohort, open-label, exploratory, phase 2 study. Patients were eligible if they had previously untreated, histologically confirmed, unilateral, invasive, HER2-positive, ER-positive br...
Eligibility Criteria
Inclusion
- We judged patients eligible for the first study cohort if they had previously untreated, histologically confirmed, unilateral, invasive, HER2-positive (3+ on immunohistochemistry or neu-amplified) and ER-positive (\>10% of cells in the tumour expressing ER) breast cancer. Other inclusion criteria were age 18 years or older, Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less, and tumour classified between cT1c and cT4a-d.
Exclusion
- metastatic disease, bilateral breast cancer, other malignant disease, inadequate bone marrow or renal function, impaired liver function, impaired cardiac function, uncontrolled hypertension, pregnancy, and refusal to use contraception.
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04858516
Start Date
April 30 2021
End Date
April 30 2025
Last Update
April 26 2021
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