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NCT04963595
Pyrotinib and Vinorelbine Tartrate Capsules With or Without Inetetamab for First Line Treatment in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer
Phase 2 trial testing Pyrotinib in Metastatic Breast Cancer in 100 participants. Status unknown.
31 January 2023
Quick facts
| Lead sponsor | Zhiyong Yu |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 August 2021 |
| Primary completion | 31 January 2023 |
| Estimated completion | 31 July 2024 |
Drugs / interventions tested
- Pyrotinib — full drug profile →
- Vinorelbine (vinorelbine) — full drug profile →
- Inetetamab — full drug profile →
Conditions studied
- Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →
Sponsor
Zhiyong Yu — full company profile →
Who can join
Adults 18 to 70, female only, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Trastuzumab resistance, which is a common therapeutic challenge in HER2 positive metastatic breast cancer, is not fully understood. Pyrotinib is an oral tyrosine kinase inhibitor targeting EGFR, HER-2 and HER-4 receptors. More general inhibition of ErbB family with pyrotinib could provide additional benefit. Inetetamab could bind to HER2 extracellular domain (ECD) with high affinity and inhibit proliferation of multiple HER2-overexpressing cancer cell lines as a single agent or in combination with trastuzumab. This study is designed to evaluate the efficacy and safety of pyrotinib and vinorelbine tartrate capsulesin with or without Inetetamab for first line treatment in patients with HER2 positive metastatic breast cancer who had early failure on or after trastuzumab treatment.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Novel HER-2 Targeted Therapies in Breast Cancer.
Fernandes CL, Silva DJ, Mesquita A. · · 2023 · cited 9× · PMID 38201515 · DOI 10.3390/cancers16010087 -
Exploring the clinical outcomes and safety profile of inetetamab treatment in metastatic breast cancer patients: A multicenter assessment of a Chinese-origin recombinant Anti-HER2 monoclonal antibody.
Liu B, Xie N, Tian C, Feng R, et al · · 2023 · cited 8× · PMID 37944341 · DOI 10.1016/j.breast.2023.103597 -
Risk Factors for Disease Recurrence in Patients with HER2+ Early Breast Cancer and Implications for Therapy: A Narrative Review.
Cazzaniga ME, Costa L, Freyer G, Gligorov J, et al · · 2026 · PMID 41205024 · DOI 10.1007/s40487-025-00398-4
Verify or expand the search:
- PubMed search for NCT04963595
- 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 Metastatic Breast Cancer
Currently open trials in the same condition.
- NCT07524855 — A Study of HLD-0117 in Patients With Metastatic Breast Cancer · Phase 1 · recruiting
- NCT07408089 — Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer · Phase 1 · recruiting
- NCT07340541 — Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies · Phase 2 · recruiting
- NCT07233928 — Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Canc · NA · recruiting
- NCT07347600 — A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, · recruiting
Other Zhiyong Yu trials
Trials by the same sponsor.
- NCT03688035 — Potential of Circulating Tumor DNA to Assess the Tumor Response to Neoadjuvant Chemotherapy in Breast Cancer Patients · unknown
- NCT03423849 — The Maintenance Regimen and Revised Regimen for Advanced Breast Cancer Survivors After First-line Salvage Therapy · Phase 2, PHASE3 · unknown
- NCT03373708 — Risk and Clinical Benefit of Chemotherapy and Intensive Endocrine Therapy for Luminal B1 Early-stage Breast Cancer · Phase 2, PHASE3 · unknown
- NCT03349177 — Pathological Complete Response Rate in Locally Advanced Breast Cancer With FEC, EC-T, or TC as Neoadjuvant Chemotherapy · Phase 2, PHASE3 · unknown
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 NCT04963595 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Zhiyong Yu
- Last refreshed: 15 July 2021
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/NCT04963595.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing