MedTrace Logo

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

NCT04858516 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2021-04-26

No results posted yet for this study

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.

Conditions

  • Neoadjuvant Treatment for HER2-positive, ER-positive Breast Cancer

Interventions

DRUG

palbociclib and exemestane plus trastuzumab and pyrotinib

Neoadjuvant treatment with palbociclib and exemestane plus trastuzumab and pyrotinib in ER-positive, HER2-positive breast cancer

Sponsors & Collaborators

  • Guangdong Provincial People's Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2024-04-30
Completion
2025-04-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04858516 on ClinicalTrials.gov