Last reviewed · How we verify
NCT05561686
Real-world Study of Pyrotinib in Neoadjuvant Therapy for HER2-positive Breast Cancer
trial testing Pyrotinib in HER2-positive Breast Cancer in 100 participants. Status unknown.
1 October 2024
Quick facts
| Lead sponsor | Hunan Cancer Hospital |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 1 October 2022 |
| Primary completion | 1 October 2024 |
| Estimated completion | 1 October 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Pyrotinib — full drug profile →
Conditions studied
- HER2-positive Breast Cancer — all drugs for HER2-positive Breast Cancer →
Sponsor
Hunan Cancer Hospital
Who can join
Adults 18 to 65, female only, with HER2-positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Pyrotinib is currently being investigated in both registration studies and investigator-initiated studies in the neoadjuvant and adjuvant setting for HER2-positive breast cancer, all of which are RCTs, but randomized clinical studies have selected specific populations in defined settings, which may differ from the actual clinical setting. Given the limited real-world data on pyrotinib, real-world studies focusing on neoadjuvant therapy have not been reported. At present, we hope to collect the data of neoadjuvant therapy for HER2-positive breast cancer patients who have been prescribed pyrotinib, and explore the efficacy and safety of pyrotinib-based neoadjuvant therapy for HER2-positive early or locally advanced breast cancer patients; exploratory analysis to explore the correlation between TMB levels and pCR rate of neoadjuvant therapy in HER2-positive breast cancer patients, and the effect of pyrotinib-based neoadjuvant therapy on intestinal flora.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Gut microbiota interact with breast cancer therapeutics to modulate efficacy.
Arnone AA, Ansley K, Heeke AL, Howard-McNatt M, et al · · 2025 · cited 9× · PMID 39820166 · DOI 10.1038/s44321-024-00185-0
Verify or expand the search:
- PubMed search for NCT05561686
- 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 HER2-positive Breast Cancer
Currently open trials in the same condition.
- NCT07459673 — HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term · Phase 2 · recruiting
- NCT07377643 — IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer · Phase 3 · recruiting
- NCT07510802 — Dual-Target CAR-NK Cells for Advanced Breast Cancer HER2+ TNBC · Phase 1, PHASE2 · recruiting
- NCT07486089 — Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC) · Phase 1, PHASE2 · recruiting
- NCT07102381 — A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Ca · Phase 2 · recruiting
Other Hunan Cancer Hospital trials
Trials by the same sponsor.
- NCT07314216 — Firmonertinib Combined With Definitive Radiotherapy in Stage III Unresectable EGFR Uncommon Mutant Pulmonary Adenocarcin · Phase 2 · not yet recruiting
- NCT07083687 — Lorlatinib in ROS1+ NSCLC With Brain Metastasis · Phase 2 · not yet recruiting
- NCT07098026 — Shenqi Fuwei Mixture Combined With Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric Cancer · NA · recruiting
- NCT06840704 — Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer · Phase 3 · recruiting
- NCT06788002 — LDRT and Chemoimmunotherapy in NPC With Liver Metastasis · Phase 2 · 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 NCT05561686 (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 Hunan Cancer Hospital
- Last refreshed: 30 September 2022
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/NCT05561686.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing