Who is sponsoring NCT00251433?

NCT00251433 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT00251433?

Interventions in NCT00251433: lapatinib, docetaxel, trastuzumab.

What condition does NCT00251433 study?

NCT00251433 studies Neoplasms, Breast.

Is NCT00251433 still recruiting?

NCT00251433 is currently terminated. Last updated 31 March 2023.

Last reviewed 2023-03-31 · How we verify

NCT00251433

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

GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer

Terminated Phase 1 Last updated 31 March 2023

What this trial tests

Phase 1 trial testing lapatinib, docetaxel, trastuzumab in Neoplasms, Breast in 53 participants. Terminated before completion.

Timeline

26 September 2005

Primary endpoint
10 June 2010

22 June 2022

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	53
Start date	26 September 2005
Primary completion	10 June 2010
Estimated completion	22 June 2022
Sites	5 locations across France, Ireland, United States

Drugs / interventions tested

lapatinib, docetaxel, trastuzumab — full drug profile →

Conditions studied

Neoplasms, Breast — all drugs for Neoplasms, Breast →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

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

Sponsor's own description

This study was designed to be two-part study (Phase I/Phase II). Part I was designed to find the optimal (best) doses of GW572016, docetaxel, and trastuzumab when given together. Part II was designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving all three drugs compared to patients receiving only docetaxel and trastuzumab.

Publications & conference data

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

Challenges in the Treatment of Triple Negative and HER2-Overexpressing Breast Cancer.
Hoeferlin LA, E Chalfant C, Park MA. · · 2013 · cited 24× · PMID 24818173
Optimally tolerated dose of lapatinib in combination with docetaxel plus trastuzumab in first-line treatment of HER2-positive metastatic breast cancer.
Crown J, Kennedy MJ, Tresca P, Marty M, et al · · 2013 · cited 13× · PMID 23878115 · DOI 10.1093/annonc/mdt222
Real-World Data of Triplet Combination of Trastuzumab, Lapatinib, and Chemotherapy in HER2-Positive Metastatic Breast Cancer: A Multicenter Retrospective Study.
Li Y, Gong C, Lu Q, Zhou Z, et al · · 2020 · cited 9× · PMID 32195186 · DOI 10.3389/fonc.2020.00271

Verify or expand the search:

Other recruiting trials for Neoplasms, Breast

Currently open trials in the same condition.

NCT06819215 — Phase I/II Clinical Study to Evaluate VB15010 Tablets in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT04915755 — Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HE · Phase 3 · active not recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00251433 (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 Novartis Pharmaceuticals
Last refreshed: 31 March 2023

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/NCT00251433.

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