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A Randomized Phase III Trial of Neoadjuvant Therapy for Patients With Palpable and Operable HER2-Positive Breast Cancer Comparing the Combination of Trastuzumab Plus Lapatinib to Trastuzumab and to Lapatinib Administered With Weekly Paclitaxel Following AC [doxorubicin + cyclophosphamide] Accompanied by Correlative Science Studies to Identify Predictors of Pathologic Complete Response

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A Randomized Phase III Trial of Neoadjuvant Therapy for Patients With Palpable and Operable HER2-Positive Breast Cancer Comparing the Combination of Trastuzumab Plus Lapatinib to Trastuzumab and to Lapatinib Administered With Weekly Paclitaxel Following AC [doxorubicin + cyclophosphamide] Accompanied by Correlative Science Studies to Identify Predictors of Pathologic Complete Response

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Jul 2024

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At a glance

  • Drugs Lapatinib (Primary) ; Cyclophosphamide; Doxorubicin; Paclitaxel; Trastuzumab
  • Indications Adenocarcinoma; Early breast cancer; HER2 positive breast cancer
  • Focus Therapeutic Use
  • Sponsors GlaxoSmithKline

    • Most Recent Events

    • 04 Jun 2024 Results (n=257) assessing association between stromal tumor-infiltrating lymphocytes (TILs) and pathologic complete response (pCR) were presented at the 60th Annual Meeting of the American Society of Clinical Oncology.
    • 07 Jun 2022 Results of a pooled analysis of CALGB 40601, NeoALTTO, and NSABP B-41 studies assessed the the association of intrinsic subtypes and gene expression signatures with pathologic complete response and event-free survival presented at the 58th Annual Meeting of the American Society of Clinical Oncology
    • 05 May 2020 Results (n=130) of biomarker analyses assessing prognostic utility of ERBB2, ESR1 and other genomic markers were published in the Clinical Cancer Research

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