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NCT02738970
A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC)
Phase 1 trial testing Trastuzumab in Early Breast Cancer in 88 participants. Completed in 31 May 2018.
31 May 2018
Quick facts
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 88 |
| Start date | 23 June 2016 |
| Primary completion | 31 May 2018 |
| Estimated completion | 31 May 2018 |
| Sites | 2 locations across New Zealand |
Drugs / interventions tested
- Trastuzumab (trastuzumab) — full drug profile →
- Pertuzumab (pertuzumab) — full drug profile →
Conditions studied
- Early Breast Cancer — all drugs for Early Breast Cancer →
Sponsor
Hoffmann-La Roche — full company profile →
Who can join
Adults 18 to 45, any sex, with Early Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study involves a two-part design. Part 1 is designed to determine the optimal dose of subcutaneous (SC) Perjeta, injected alone or mixed with Herceptin, that results in comparable exposure to intravenous (IV) Perjeta. Exposure between SC Perjeta and IV Perjeta will be compared using a compilation of pharmacokinetic (PK) parameters such as area under the concentration-time curve (AUC), maximum serum concentration (Cmax), time of maximum concentration (Tmax), and serum trough concentration (Ctrough). Part 2 is designed to confirm the dosing regimen in women with EBC on the basis of safety, tolerability, and PK assessments.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Development of a Subcutaneous Fixed-Dose Combination of Pertuzumab and Trastuzumab: Results From the Phase Ib Dose-Finding Study.
Kirschbrown WP, Wynne C, Kågedal M, Wada R, et al · · 2019 · cited 28× · PMID 30570763 · DOI 10.1002/jcph.1362 -
Therapeutic innovations in triple negative breast cancer: integrating molecular targeting and monoclonal antibody strategies.
Mir PA, Kumar N, Gupta SK, Kaur A, et al · · 2025 · PMID 41069341 · DOI 10.3389/fonc.2025.1645438
Verify or expand the search:
- PubMed search for NCT02738970
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Hoffmann-La Roche 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 NCT02738970 (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 Hoffmann-La Roche
- Last refreshed: 12 June 2018
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/NCT02738970.
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