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NCT05800756
Pyrotinib Combined With Trastuzumab,Dalpiciclib and Letrozole for HR+/HER2+ Breast Cancer
Phase 2 trial testing pyrotinib combined with trastuzumab, dalpiciclib and letrozole in Breast Cancer in 30 participants. Status unknown.
31 May 2024
Quick facts
| Lead sponsor | Yantai Yuhuangding Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 4 August 2022 |
| Primary completion | 31 May 2024 |
| Estimated completion | 30 July 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- pyrotinib combined with trastuzumab, dalpiciclib and letrozole — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Yantai Yuhuangding Hospital
Who can join
18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this single arm, open label, phase 2 trial, operable patients with stage II-III HR+/HER2+ breast cancer will be enrolled and receive two cycles of pyrotinib combined with trastuzumab, dalpiciclib and letrozole. Imaging evaluation was performed two weeks later, and patients who achieved CR or PR were continued with the original regimen for 4 cycles. Subjects who did not achieve PR switched to regimen and received 4 cycles of pyrotinib combined with trastuzumab plus chemotherapy. This study aims to assessed the biological effects and safety of pyrotinib combined with trastuzumab, dalpiciclib and letrozole for HR+/HER2+ breast cancer in the neoadjuvant setting.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting CDK4/6 in breast cancer.
Shanabag A, Armand J, Son E, Yang HW. · · 2025 · cited 21× · PMID 39930131 · DOI 10.1038/s12276-025-01395-3 -
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 -
Next Frontier in HER2+/HR+ Breast Cancer: Leveraging Cell Cycle Control with CDK4/6 Inhibitors.
Poli I, Oliva GR, Mongelli G, Rotondi A, et al · · 2026 · PMID 41893011 · DOI 10.3390/jpm16030143
Verify or expand the search:
- PubMed search for NCT05800756
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Yantai Yuhuangding Hospital trials
Trials by the same sponsor.
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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 NCT05800756 (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 Yantai Yuhuangding Hospital
- Last refreshed: 6 April 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/NCT05800756.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing