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A Randomized Phase II Study of MCS110 Combined With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)

Trial Profile

A Randomized Phase II Study of MCS110 Combined With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 29 Dec 2021

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At a glance

  • Drugs Lacnotuzumab (Primary) ; Carboplatin; Gemcitabine
  • Indications Advanced breast cancer
  • Focus Therapeutic Use
  • Sponsors Novartis; Novartis Pharma A.G.; Novartis Pharmaceuticals

Most Recent Events

  • 06 Oct 2021 a protocol amendment after the enrollment halt where survival follow-up was removed, biomarker sample collections were no longer required and the frequency of post Cycle 8 assessments was reduced from every 9 weeks to a minimum of every 12 weeks until disease progression, and at the end-of-treatment visit, as per results published in the Clinical Cancer Research
  • 06 Oct 2021 Primary endpoint (Progression Free Survival (PFS) as Per RECIST v1.1 (by Local Investigator Assessment)) has not been met as per results published in the Clinical Cancer Research
  • 06 Oct 2021 Results published in the Clinical Cancer Research

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