Neoadjuvant Treatment With Palbociclib and Exemestane Plus Trastuzumab and Pyrotinib in Estrogen Receptor (ER)-Positive, HER2-positive Breast Cancer

Phase 2

Not yet recruiting

• Conditions: Neoadjuvant Treatment for HER2-positive, ER-positive Breast Cancer
• Interventions: Drug: palbociclib and exemestane plus trastuzumab and pyrotinib

• Registration Number: NCT04858516
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-18
• Study First Submitted QC: 2021-04-23
• Last Update Submitted: 2021-04-23
• Study First Posted: 2021-04-26
• Last Update Posted: 2021-04-26
• Study Start: 2021-04-30
• Primary Completion: 2024-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 57

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant treatment with palbociclib and exemestane plus trastuzumab and pyrotinib	palbociclib and exemestane plus trastuzumab and pyrotinib	-

Primary Outcome Measures

Name	Time	Method
pathological complete response(ypT0/is,ypN0, pCR)	24 weeks	defined as the absence of invasive tumor cells in breast and axilla, ypT0/is ypN0