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NCT04481932
Trastuzumab Combined With Pyrotinib and Chemotherapy for Locally Advanced, Inflammatory, or Early HER2-positive Mammary glandsCancer: One Arm, Open, Phase II Clinical Study
Phase 2 trial testing Trastuzumab combined with Pyrotinib and chemotherapy in HER2-positive Breast Cancer in 104 participants. Currently enrolling.
1 June 2022
Quick facts
| Lead sponsor | Peking University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 104 |
| Start date | 1 July 2020 |
| Primary completion | 1 June 2022 |
| Estimated completion | 1 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Trastuzumab combined with Pyrotinib and chemotherapy — full drug profile →
Conditions studied
- HER2-positive Breast Cancer — all drugs for HER2-positive Breast Cancer →
Sponsor
Peking University
Who can join
Adults 18 to 70, female only, with HER2-positive Breast Cancer. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
pathological complete response (pCR)
Time frame: From enrollment to 18 weeks
Breast without invasive carcinoma and carcinoma in situ or only carcinoma in situ (ypT0 or ypT0/is)
Sponsor's own description
This study is a one-arm, open, phase II clinical study, and the study subjects are locally advanced and inflammatoryPatients with sexual or early HER2-positive breast cancer entered the trial period after signing informed consentTo evaluate trastuzumab combined with pyrrolitinib and chemotherapy regimen (TCbH+Py) for HER2 positive breastPathologic complete response rate (pCR) for adenocarcinoma.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Beyond HER2: Targeting the ErbB receptor family in breast cancer.
Drago JZ, Ferraro E, Abuhadra N, Modi S. · · 2022 · cited 39× · PMID 35870237 · DOI 10.1016/j.ctrv.2022.102436 -
Neratinib for HER2-positive breast cancer with an overlooked option.
Guo L, Shao W, Zhou C, Yang H, et al · · 2023 · cited 33× · PMID 37803271 · DOI 10.1186/s10020-023-00736-0 -
Signaling pathway dysregulation in breast cancer.
Ryspayeva D, Seyhan AA, MacDonald WJ, Purcell C, et al · · 2025 · cited 9× · PMID 40080721 · DOI 10.18632/oncotarget.28701
Verify or expand the search:
- PubMed search for NCT04481932
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 Peking University trials
Trials by the same sponsor.
- NCT07519122 — Fangshan Active Nutrition Initiative · NA · not yet recruiting
- NCT07466238 — HAIC Plus Systemic Therapy as De-escalation Therapy Strategy for Biliary Tract Cancer · NA · recruiting
- NCT07480525 — Efficacy and Mechanisms of Escitalopram in Drug-Naïve First-Episode Major Depressive Disorder · NA · not yet recruiting
- NCT07454031 — Intraperitoneal PX in Combination With Nab-Paclitaxel in Patients With Peritoneal Metastatic Mucinous Adenocarcinoma · Phase 1 · not yet recruiting
- NCT07466225 — HAIC Plus Lenva and PD-1 for Advanced HCC With Macrovascular or Biliary Invasion · 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 NCT04481932 (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 Peking University
- Last refreshed: 19 July 2020
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/NCT04481932.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing