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NCT05638594
Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer
Phase 2 trial testing Pyrotinib in Breast Cancer in 236 participants. Currently enrolling.
10 December 2025
Quick facts
| Lead sponsor | Shengjing Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 236 |
| Start date | 20 December 2022 |
| Primary completion | 10 December 2025 |
| Estimated completion | 10 December 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Pyrotinib
- Trastuzumab (trastuzumab) — full drug profile →
- Dalpiciclib
- Letrozole — full drug profile →
- Pertuzumab (pertuzumab) — full drug profile →
- Docetaxel
- Carboplatin (Carboplatin) — full drug profile →
- Gonadotropin-releasing hormone agonist
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Shengjing Hospital
Who can join
Adults 18 to 75, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an investigator-initiated randomized controlled, open-label, multicenter, prospective Phase 2 clinical study. Patients with stage II-III HR +/HER2 + breast cancer were randomly divided into two groups at a ratio of 1:1. The experimental group received pyrotinib combined with trastuzumab, dalpiciclib and letrozole; the control group received trastuzumab combined with pertuzumab, docetaxel and carboplatin. The main study objective was to evaluate the efficacy and safety of neoadjuvant therapy for HR +/HER2 + breast cancer in the two groups.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Molecular classification of hormone receptor-positive /HER2-positive breast cancer reveals potential neoadjuvant therapeutic strategies.
Liu C, Sun L, Niu N, Hou P, et al · · 2025 · cited 9× · PMID 40133264 · DOI 10.1038/s41392-025-02181-3 -
A pilot trial of neoadjuvant pyrotinib plus trastuzumab, dalpiciclib, and letrozole for triple-positive breast cancer.
Huo S, Xue J, Wang S, Shan H, et al · · 2024 · cited 8× · PMID 38469548 · DOI 10.1002/mco2.505 -
Docetaxel Resistance in Breast Cancer: Current Insights and Future Directions.
Postigo-Corrales F, Beltrán-Videla A, Lázaro-Sánchez AD, Hurtado AM, et al · · 2025 · cited 5× · PMID 40806254 · DOI 10.3390/ijms26157119 -
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
Verify or expand the search:
- PubMed search for NCT05638594
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Pyrotinib
Trials testing the same drug.
- NCT06495541 — The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive · NA · not yet recruiting
- NCT07470203 — Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer · not yet recruiting
- NCT07417241 — SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study · Phase 2 · not yet recruiting
- NCT07340398 — Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Subop · Phase 2 · recruiting
- NCT07179939 — Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study · Phase 2 · not yet recruiting
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
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Other Shengjing Hospital trials
Trials by the same sponsor.
- NCT07484763 — Predicting Recurrence in HR+/HER2- Early Breast Cancer · not yet recruiting
- NCT07497191 — AMH Dynamic Changes to Predict Ovarian Reserve in Perimenopausal Breast Cancer · not yet recruiting
- NCT07320599 — Neuroendoscopic Surgery With Ommaya Reservoir Implantation vs. Burr Hole Drainage for Infantile Postmeningitis Subdural · not yet recruiting
- NCT07153783 — Interventional AI-Human Collaboration for Liver Tumor Diagnosis · NA · completed
- NCT07101614 — A Randomized Study of JS004 and Toripalimab Combined With Chemotherapy vs Toripalimab Combined With Chemotherapy vs Chem · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05638594 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shengjing Hospital
- Last refreshed: 20 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05638594.
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