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A Phase III, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer

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A Phase III, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Feb 2024

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At a glance

  • Drugs Pertuzumab (Primary) ; Docetaxel; Trastuzumab
  • Indications Adenocarcinoma; Advanced breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms CLEOPATRA
  • Sponsors Chugai Pharmaceutical; Genentech; Roche

    • Most Recent Events

    • 11 Jan 2024 Results (n=780)evaluating the prognostic role of the baseline neutrophil/lymphocyte ratio (NLR) in HER2-positive metastatic breast cancer (MBC) patients treated with trastuzumab/pertuzumab, published in the Breast Cancer Research
    • 18 Dec 2021 The trial has been completed in Italy, according to the European Clinical Trials Database record.
    • 16 Mar 2021 According to a Roche media release, based on data from (NeoSphere, TRYPHAENA, BERENICE,CLEOPATRA ) trials, the Health Canada has granted market authorization to Perjeta (pertuzumab for injection) as a neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either >2 cm in diameter or node positive)

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