deltatrials
Completed PHASE2 INTERVENTIONAL 3-arm NCT01204125

Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients (SOLTI NEOPARP)

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)

Sponsor: SOLTI Breast Cancer Research Group

Updated 8 times since 2017 Last updated: Mar 21, 2017 Started: Sep 30, 2010 Primary completion: Oct 31, 2012 Completion: Feb 28, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Breast Cancer Female and is currently completed. SOLTI Breast Cancer Research Group leads this study, which shows 8 recorded versions since 2010 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotActive Not Recruiting~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshotActive Not Recruiting~Apr 2017 – ~Jun 2018 · 14 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

Show 3 earlier versions
  1. Apr 2017 — Jun 2018 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

  2. Feb 2017 — Apr 2017 [monthly]

    Active Not Recruiting PHASE2

  3. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE2

    First recorded

Sep 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • SOLTI Breast Cancer Research Group
  • Sanofi
Data source: Sanofi

For direct contact, visit the study record on ClinicalTrials.gov .