Clinical trial · Interventional
Neoadjuvant Treatment With Palbociclib and Exemestane Plus Trastuzumab and Pyrotinib in Estrogen Receptor (ER)-Positive, HER2-positive Breast Cancer
Neoadjuvant Treatment With Palbociclib and Exemestane Plus Trastuzumab and Pyrotinib in ER-positive, HER2-positive Breast Cancer (neoPEHP): an Exploratory, Open-label, Multi-center Phase 2 Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoadjuvant Treatment for HER2-positive, ER-positive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| palbociclib and exemestane plus trastuzumab and pyrotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant treatment with palbociclib and exemestane plus trastuzumab and pyrotinib
- interventionNames
- Drug: palbociclib and exemestane plus trastuzumab and pyrotinib
Primary outcomes (1)
- measure
- pathological complete response(ypT0/is,ypN0, pCR)
- timeFrame
- 24 weeks
- description
- defined as the absence of invasive tumor cells in breast and axilla, ypT0/is ypN0
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available