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NCT05188495: HELP
Trastuzumab(Henlius®) Combined With Pertuzumab(Perjeta®) and Chemotherapy in Chinese Patients With Her2-Positive Metastatic Breast Cancer Previously Treated With Trastuzumab
trial testing trastuzumab(Henlius®) combined with Pertuzumab(Perjeta®) and Chemotherapy in HER2-positive Metastatic Breast Cancer in 60 participants. Status unknown.
10 December 2023
Quick facts
| Lead sponsor | Peking University Cancer Hospital & Institute |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 10 May 2021 |
| Primary completion | 10 December 2023 |
| Estimated completion | 10 December 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- trastuzumab(Henlius®) combined with Pertuzumab(Perjeta®) and Chemotherapy — full drug profile →
Conditions studied
- HER2-positive Metastatic Breast Cancer — all drugs for HER2-positive Metastatic Breast Cancer →
- Previously Treated With Trastuzumab — all drugs for Previously Treated With Trastuzumab →
- Trastuzumab Combined With Pertuzumab and Chemotherapy — all drugs for Trastuzumab Combined With Pertuzumab and Chemotherapy →
Sponsor
Peking University Cancer Hospital & Institute
Who can join
18 and older, any sex, with HER2-positive Metastatic Breast Cancer or Previously Treated With Trastuzumab. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Currently, data of the efficacy of trastuzumab plus pertuzumab and chemotherapy is limited in the HER2 positive metastatic breast cancer patients previously treated with trastuzumab during (neo)adjuvant and metastatic setting, and results are not consistent.The main purpose of this study is to evaluate the 6-month progression free survival(PFS) of trastuzumab(Henlius®) combined with Pertuzumab(Perjeta®) and Chemotherapy as first to third line therapy in Chinese patients with HER2 positive metastatic breast cancer who received trastuzumab previously.Primary Endpoint is 6-month Progression-free survival (PFS);Secondary Endpoint(s) include Progression-free survival (PFS) Overall Survival (OS);Objective Response Rate(ORR);
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Trastuzumab Biosimilar (HLX02), Pertuzumab Plus Chemotherapy in Patients with HER2-Positive Metastatic Breast Cancer after Progression of Trastuzumab: A Prospective, Phase II Study.
Zhang R, Liu X, Song G, Zhang Y, et al · · 2024 · cited 1× · PMID 38147816 · DOI 10.4143/crt.2023.1151
Verify or expand the search:
- PubMed search for NCT05188495
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for HER2-positive Metastatic Breast Cancer
Currently open trials in the same condition.
- NCT06714617 — Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors · Phase 1 · active not recruiting
- NCT06551116 — QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer · recruiting
- NCT06278870 — Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial · Phase 3 · recruiting
- NCT05959291 — Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer · NA · recruiting
- NCT05868226 — PRE-I-SPY Phase I/Ib Oncology Platform Program · Phase 1 · recruiting
Other Peking University Cancer Hospital & Institute trials
Trials by the same sponsor.
- NCT07527806 — Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Im · Phase 2 · not yet recruiting
- NCT07529002 — Clinical Application of 89Zr-s-C1 PET/CT Imaging in Solid Tumors · recruiting
- NCT07417241 — SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study · Phase 2 · not yet recruiting
- NCT07470203 — Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer · not yet recruiting
- NCT07394192 — Short-Course Radiotherapy With Tumor-Draining Lymph Node Preservation Followed by PD-1 Inhibitors in pMMR/MSS Stage II-I · 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 NCT05188495 (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 Cancer Hospital & Institute
- Last refreshed: 12 January 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/NCT05188495.
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