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A Randomised, Open-Label, Phase III Study of Taxane Based Chemotherapy with Lapatinib or Trastuzumab as First-Line Therapy for Women With HER2/neu Positive Metastatic Breast Cancer ['COMPLETE' study: Comparison of Lapatinib Efficacy vs. Trastuzumab, Each with a Taxane in First Line Metastatic Breast Cancer]

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Trial Profile

A Randomised, Open-Label, Phase III Study of Taxane Based Chemotherapy with Lapatinib or Trastuzumab as First-Line Therapy for Women With HER2/neu Positive Metastatic Breast Cancer ['COMPLETE' study: Comparison of Lapatinib Efficacy vs. Trastuzumab, Each with a Taxane in First Line Metastatic Breast Cancer]

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Mar 2025

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At a glance

  • Drugs Lapatinib (Primary) ; Trastuzumab (Primary) ; Docetaxel; Paclitaxel
  • Indications Adenocarcinoma; Advanced breast cancer; HER2 positive breast cancer
  • Focus Biomarker; Pharmacogenomic; Registrational; Therapeutic Use
  • Acronyms COMPLETE
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Research & Development; GSK; Novartis; Novartis Pharma A.G.; Novartis Pharmaceuticals

Most Recent Events

  • 29 Jun 2022 Planned End Date changed from 31 Dec 2022 to 26 Aug 2022.
  • 04 Jun 2019 Results (n=382, 184 in trastuzumab arm, 198 in lapatinib arm) assessing elevated serum activin A and PD-L1 and survival in patients from this trial, presented at the 55th Annual Meeting of the American Society of Clinical Oncology.
  • 23 Apr 2017 Planned End Date changed from 21 Dec 2017 to 31 Dec 2019.

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