Neoadjuvant Treatment for HER2-positive, ER-positive Breast Cancer
Conditions
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 breast cancer and were suitable for neoadjuvant therapy. Patients were treated every 3 weeks with intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg) and oral pyrotinib (400 mg po QD) for six cycles plus oral palbociclib (125 mg once a day for 21 days in a 4-week cycle) and oral exemestane (25 mg po QD) every 4 weeks for 24 weeks. The primary endpoints was pathological complete response.
Interventions
DRUGpalbociclib and exemestane plus trastuzumab and pyrotinib
Neoadjuvant treatment with palbociclib and exemestane plus trastuzumab and pyrotinib in ER-positive, HER2-positive breast cancer
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathological complete response(ypT0/is,ypN0, pCR) | 24 weeks | defined as the absence of invasive tumor cells in breast and axilla, ypT0/is ypN0 |
Outcome results
None listed