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Randomized, Open-label, Phase 2 Study of the Efficacy and Safety of Weekly Paclitaxel Single-agent and Two Different Regimens of the PARP-1 Inhibitor SAR240550 (BSI-201) in Combination With Weekly Paclitaxel, as Neoadjuvant Therapy in Patients With Stage II-IIIA Triple Negative Breast Cancer (TNBC).

Trial Profile

Randomized, Open-label, Phase 2 Study of the Efficacy and Safety of Weekly Paclitaxel Single-agent and Two Different Regimens of the PARP-1 Inhibitor SAR240550 (BSI-201) in Combination With Weekly Paclitaxel, as Neoadjuvant Therapy in Patients With Stage II-IIIA Triple Negative Breast Cancer (TNBC).

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 08 Nov 2021

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At a glance

  • Drugs Iniparib (Primary) ; Paclitaxel
  • Indications Early breast cancer; Triple negative breast cancer
  • Focus Therapeutic Use
  • Acronyms SOLTI-NEOPARP
  • Sponsors Sanofi

Most Recent Events

  • 21 Mar 2017 Status changed from active, no longer recruiting to completed.
  • 17 Mar 2017 This trial has been completed in Spain.
  • 05 Sep 2012 Planned end date changed from 1 Mar 2013 to 1 Feb 2017 as reported by ClinicalTrials.gov.

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