NCT04858516

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

Status unknown Phase 2 Last updated 26 April 2021

What this trial tests

Phase 2 trial testing palbociclib and exemestane plus trastuzumab and pyrotinib in Neoadjuvant Treatment for HER2-positive, ER-positive Breast Cancer in 57 participants. Status unknown.

Timeline

30 April 2021

Primary endpoint
30 April 2024

30 April 2025

Quick facts

Lead sponsor	Guangdong Provincial People's Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	57
Start date	30 April 2021
Primary completion	30 April 2024
Estimated completion	30 April 2025

Drugs / interventions tested

• palbociclib and exemestane plus trastuzumab and pyrotinib — full drug profile →

Conditions studied

• Neoadjuvant Treatment for HER2-positive, ER-positive Breast Cancer — all drugs for Neoadjuvant Treatment for HER2-positive, ER-positive Breast Cancer →

Sponsor

Guangdong Provincial People's Hospital

Who can join

18 and older, female only, with Neoadjuvant Treatment for HER2-positive, ER-positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting Cell Cycle Progression in HER2+ Breast Cancer: An Emerging Treatment Opportunity.
   Koirala N, Dey N, Aske J, De P. · · 2022 · cited 17× · PMID 35742993 · DOI 10.3390/ijms23126547
2. Novel HER-2 Targeted Therapies in Breast Cancer.
   Fernandes CL, Silva DJ, Mesquita A. · · 2023 · cited 9× · PMID 38201515 · DOI 10.3390/cancers16010087
3. Clinical considerations of CDK4/6 inhibitors in HER2 positive breast cancer.
   Zhang C, Zhou F, Zou J, Fang Y, et al · · 2023 · cited 3× · PMID 38293701 · DOI 10.3389/fonc.2023.1322078
4. Efficacy and Predictability of Cyclin-Dependent Kinase 4/6 Inhibitors in HER2-Positive Breast Cancer.
   Abbasi MS, Afzal MZ, Sarwar T, Gamlen-Steves HA. · · 2025 · cited 1× · PMID 40940886 · DOI 10.3390/cancers17172788