deltatrials
Completed PHASE1 INTERVENTIONAL 1-arm NCT02780401

Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission (WOKVAC)

A Phase I Trial of the Safety and Immunogenicity of a DNA Plasmid Based Vaccine (WOKVAC) Encoding Epitopes Derived From Three Breast Cancer Antigens (IGFBP-2, HER2, and IGF-1R) in Patients With Breast Cancer

Sponsor: National Cancer Institute (NCI)

Conditions HER2/Neu Negative No Evidence of Disease One or More Positive Axillary Nodes Stage IB Breast Cancer Stage II Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage III Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer
Interventions Laboratory Biomarker Analysis Sargramostim pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine
Updated 16 times since 2017 Last updated: Aug 23, 2024 Started: Sep 2, 2016 Primary completion: Oct 8, 2020 Completion: Oct 8, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on HER2/Neu Negative and No Evidence of Disease, this trial is completed. The trial is conducted by National Cancer Institute (NCI) and has accumulated 16 data snapshots since 2016. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshot~Jun 2017 – ~Dec 2017 · 6 months · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Jan 2019 · 7 months · monthly snapshot~Jan 2019 – ~Mar 2019 · 59 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~Feb 2020 · 10 months · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Jan 2021 · 10 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Feb 2022 · 5 months · monthly snapshot~Feb 2022 – ~Jul 2024 · 29 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – present · 21 months · monthly snapshot

Change History

16 versions recorded

  1. Oct 2024 — Present [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

  2. Sep 2024 — Oct 2024 [monthly]

    Active Not Recruiting PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1

  4. Feb 2022 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1

  5. Sep 2021 — Feb 2022 [monthly]

    Active Not Recruiting PHASE1

▶ Show 11 earlier versions

  1. Jan 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE1

  2. Mar 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  3. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE1

  4. Apr 2019 — Feb 2020 [monthly]

    Recruiting PHASE1

    Status: Suspended → Recruiting

  5. Mar 2019 — Apr 2019 [monthly]

    Suspended PHASE1

    Status: Recruiting → Suspended

  6. Jan 2019 — Mar 2019 [monthly]

    Recruiting PHASE1

  7. Jun 2018 — Jan 2019 [monthly]

    Recruiting PHASE1

  8. Dec 2017 — Jun 2018 [monthly]

    Recruiting PHASE1

  9. Jun 2017 — Dec 2017 [monthly]

    Recruiting PHASE1

  10. Feb 2017 — Jun 2017 [monthly]

    Recruiting PHASE1

  11. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1

    First recorded

Sep 2016

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
  • University of Wisconsin, Madison
Data source: University of Washington

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

Study Locations