NCT01810393 is a Phase 3 clinical trial of Trastuzumab in Breast Cancer, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT01810393?

NCT01810393 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT01810393?

Interventions in NCT01810393: Trastuzumab.

What condition does NCT01810393 study?

NCT01810393 studies Breast Cancer.

Is NCT01810393 still recruiting?

NCT01810393 is currently completed. Last updated 4 September 2020.

Last reviewed 2020-09-04 · How we verify

NCT01810393

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Assess Preference for Subcutaneous Trastuzumab Treatment in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Metastatic Breast Cancer Responding to First-Line Intravenous Trastuzumab for at Least 3 Years

Completed Phase 3 Last updated 4 September 2020

What this trial tests

Phase 3 trial testing Trastuzumab in Breast Cancer in 114 participants. Completed in 17 July 2019.

Timeline

11 June 2013

Primary endpoint
17 July 2019

17 July 2019

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	114
Start date	11 June 2013
Primary completion	17 July 2019
Estimated completion	17 July 2019
Sites	61 locations across France

Drugs / interventions tested

Trastuzumab (trastuzumab) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This open-label, randomized, multicenter study will evaluate participant preference for subcutaneous (SC) versus intravenous (IV) trastuzumab (Herceptin) in participants with HER2-positive metastatic breast cancer responding to first-line treatment with IV trastuzumab for at least 3 years. Participants will be randomized to receive either 3 cycles (cycle length = 21 days) of trastuzumab SC followed by 3 cycles of trastuzumab IV or 3 cycles of trastuzumab IV followed by 3 cycles of trastuzumab SC. All participants will receive trastuzumab SC for Cycles 7 to 18. Anticipated time on study treatment is 1 year or until disease progression or inacceptable toxicity occurs, whichever comes first.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Patients' preference of trastuzumab administration (subcutaneous versus intravenous) in HER2-positive metastatic breast cancer: Results of the randomised MetaspHer study.
Pivot X, Spano JP, Espie M, Cottu P, et al · · 2017 · cited 53× · PMID 28648618 · DOI 10.1016/j.ejca.2017.05.009
A Systematic Review of Time and Resource Use Costs of Subcutaneous Versus Intravenous Administration of Oncology Biologics in a Hospital Setting.
McCloskey C, Ortega MT, Nair S, Garcia MJ, et al · · 2023 · cited 36× · PMID 35996066 · DOI 10.1007/s41669-022-00361-3
Intravenous and subcutaneous formulations of trastuzumab, and trastuzumab biosimilars: implications for clinical practice.
Waller CF, Möbius J, Fuentes-Alburo A. · · 2021 · cited 30× · PMID 33589773 · DOI 10.1038/s41416-020-01255-z
A multidisciplinary perspective on the subcutaneous administration of trastuzumab in HER2-positive breast cancer.
Dent S, Ammendolea C, Christofides A, Edwards S, et al · · 2019 · cited 26× · PMID 30853812 · DOI 10.3747/co.26.4220
Real-World Data on Health-Related Quality of Life Assessment in Patients With Breast Cancer Receiving Subcutaneous Trastuzumab.
Syrios J, Pappa E, Volakakis N, Grivas A, et al · · 2018 · cited 9× · PMID 29511355 · DOI 10.1177/1178223418758031
The burden of systemic therapy administration route in treating HER2-positive breast cancer (for patients, healthcare professionals, and healthcare system): a systematic literature review.
Landeiro LCG, Martins TC, Grigolon RB, Monteiro I, et al · · 2024 · cited 5× · PMID 39224777 · DOI 10.3389/fphar.2024.1338546
Analysis of the tumor microenvironment and anti-tumor efficacy of subcutaneous vs systemic delivery of the bifunctional agent bintrafusp alfa.
Ozawa Y, Hicks KC, Minnar CM, Knudson KM, et al · · 2021 · cited 5× · PMID 33996267 · DOI 10.1080/2162402x.2021.1915561
Long Terms Follow-Up of the Randomized MetaspHER Study Comparing Intravenous Versus Subcutaneous Trastuzumab in Patients' With HER2-Positive Metastatic Breast Cancer.
Pivot X, Spano JP, Espie M, Jouannaud C, et al · · 2023 · cited 4× · PMID 37423801 · DOI 10.1016/j.clbc.2023.06.007

Verify or expand the search:

Other trials of Trastuzumab

Trials testing the same drug.

NCT07413939 — RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastati · Phase 2, PHASE3 · not yet recruiting
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NCT07402473 — EUREKA Study:Phase 2 Study to Optimize Neoadjuvant Therapy in HER2-positive Early-stage Breast Cancer · Phase 2 · not yet recruiting
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NCT07366840 — RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure · Phase 2, PHASE3 · not yet recruiting

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Other Hoffmann-La Roche trials

Trials by the same sponsor.

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NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01810393 (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: 4 September 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/NCT01810393.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing