Completed PHASE3 INTERVENTIONAL 2-arm NCT00075270

Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Phase III Study of Oral GW572016 in Combination With Paclitaxel in Subjects Previously Untreated or Advanced or Metastatic Breast Cancer

Sponsor: GlaxoSmithKline

Conditions Neoplasms, Breast

Interventions GW572016 (Lapatinib) Paclitaxel

Updated 7 times since 2017 Last updated: Apr 16, 2015 Started: Jan 31, 2004 Primary completion: Oct 31, 2006 Completion: Mar 31, 2012

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Neoplasms, Breast and is currently completed. GlaxoSmithKline leads this study, which shows 7 recorded versions since 2004 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Jan 2004

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

GlaxoSmithKline

Data source: GlaxoSmithKline

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aalen, Germany , Acapulco de Juárez, Mexico , Alcorcón/Madrid, Spain , Amarillo, United States , Amersfoort, Netherlands , Atlanta, United States , Auckland, New Zealand , Augsburg, Germany , Baltimore, United States , Banská Bystrica, Slovakia and 142 more locations