deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT00513695

Sunitinib Malate, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide Before Surgery in Treating Patients With Stage IIB-IIIC Breast Cancer

A Phase II Study Evaluating the Safety and Efficacy of Sunitinib Maleate in Combination With Weekly Paclitaxel Followed by Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF as Neoadjuvant Chemotherapy for Locally Advanced or Inflammatory Breast Cancer

Sponsor: National Cancer Institute (NCI)

Conditions Inflammatory Breast Cancer Male Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer
Interventions cyclophosphamide doxorubicin hydrochloride filgrastim flow cytometry laboratory biomarker analysis paclitaxel sunitinib malate therapeutic conventional surgery
Updated 9 times since 2017 Last updated: Jul 23, 2019 Started: Jun 30, 2007 Primary completion: Aug 31, 2012 Completion: Oct 16, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00513695, this PHASE2 trial focuses on Inflammatory Breast Cancer and Male Breast Cancer and remains completed. Sponsored by National Cancer Institute (NCI), it has been updated 9 times since 2007, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotActive Not Recruiting~Feb 2017 – ~Jul 2017 · 5 months · monthly snapshotActive Not Recruiting~Jul 2017 – ~Jun 2018 · 11 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshotActive Not Recruiting~Sep 2018 – ~Sep 2019 · 12 months · monthly snapshotActive Not Recruiting~Sep 2019 – ~Jan 2021 · 16 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

9 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  4. Sep 2019 — Jan 2021 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  5. Sep 2018 — Sep 2019 [monthly]

    Active Not Recruiting PHASE2

▶ Show 4 earlier versions

  1. Jun 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE2

  2. Jul 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE2

  3. Feb 2017 — Jul 2017 [monthly]

    Active Not Recruiting PHASE2

  4. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE2

    First recorded

Jun 2007

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
  • University of Washington
Data source: University of Washington

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

Study Locations