NCT04290793

Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer

Active, enrolled Phase 2, PHASE3 Last updated 7 January 2026

What this trial tests

Phase 2, PHASE3 trial testing Pyrotinib in Breast Cancer in 113 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 March 2020

Primary endpoint
1 December 2026

10 December 2026

Quick facts

Lead sponsor	Hebei Medical University Fourth Hospital
Phase	Phase 2, PHASE3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	113
Start date	1 March 2020
Primary completion	1 December 2026
Estimated completion	10 December 2026
Sites	1 location across China

Drugs / interventions tested

• Pyrotinib — full drug profile →
• Epirubicin (EPIRUBICIN) — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Taxanes
• Trastuzumab (trastuzumab) — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Hebei Medical University Fourth Hospital

Who can join

Adults 18 to 70, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, open label, single-arm study to evaluate the efficacy and safety of neoadjuvant pyrotinib in HER2+ breast cancer patients

Publications & conference data

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

1. Current and future landscape of targeted therapy in HER2-positive advanced breast cancer: redrawing the lines.
   Simmons C, Rayson D, Joy AA, Henning JW, et al · · 2022 · cited 21× · PMID 35035535 · DOI 10.1177/17588359211066677
2. Pyrotinib-based therapeutic approaches for HER2-positive breast cancer: the time is now.
   Qi X, Shi Q, Xuhong J, Zhang Y, et al · · 2023 · cited 17× · PMID 37789330 · DOI 10.1186/s13058-023-01694-5
3. Defining the Emergence of New Immunotherapy Approaches in Breast Cancer: Role of Myeloid-Derived Suppressor Cells.
   Sánchez-León ML, Jiménez-Cortegana C, Silva Romeiro S, Garnacho C, et al · · 2023 · cited 13× · PMID 36982282 · DOI 10.3390/ijms24065208
4. Treatment Landscape for Patients with HER2-Positive Metastatic Breast Cancer: A Review on Emerging Treatment Options.
   Gampenrieder SP, Castagnaviz V, Rinnerthaler G, Greil R. · · 2020 · cited 13× · PMID 33149670 · DOI 10.2147/cmar.s235121
5. Her2-Positive Cancers and Antibody-Based Treatment: State of the Art and Future Developments.
   Morales S, Gasol A, Sanchez DR. · · 2021 · cited 11× · PMID 34830927 · DOI 10.3390/cancers13225771
6. Novel HER-2 Targeted Therapies in Breast Cancer.
   Fernandes CL, Silva DJ, Mesquita A. · · 2023 · cited 9× · PMID 38201515 · DOI 10.3390/cancers16010087
7. Advances in the study of pyrotinib for the treatment of HER2-positive breast cancer.
   Li Y, Wang W, Liang Y, Lai H, et al · · 2026 · PMID 41776549 · DOI 10.1186/s13058-026-02255-2