deltatrials
Terminated PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT01697293

PTX-200, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide in Treating Patients With Stage IIB-IV Breast Cancer

A Phase I-II Study of PTX-200 Plus Sequential Weekly Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide in Patients With Metastatic and Locally Advanced Breast Cancer

Sponsor: National Cancer Institute (NCI)

Conditions Breast Adenocarcinoma Estrogen Receptor Positive HER2/Neu Negative Recurrent Breast Carcinoma Stage IIB Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer
Interventions Cyclophosphamide Doxorubicin Hydrochloride Laboratory Biomarker Analysis Paclitaxel Therapeutic Conventional Surgery Triciribine Phosphate
Updated 16 times since 2017 Last updated: Sep 22, 2020 Started: Jan 31, 2012 Primary completion: Jun 30, 2020 Completion: Jun 30, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

criteria for continuing enrollment in Phase 2 portion was not met

Other terminated trials from National Cancer Institute (NCI)

See all terminations from National Cancer Institute (NCI)

A PHASE1/PHASE2 clinical study on Breast Adenocarcinoma and Estrogen Receptor Positive, this trial is terminated or withdrawn. The trial is conducted by National Cancer Institute (NCI) and has accumulated 16 data snapshots since 2012. 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 – ~Feb 2018 · 12 months · monthly snapshot~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Apr 2019 · 9 months · monthly snapshot~Apr 2019 – ~Sep 2019 · 5 months · monthly snapshot~Sep 2019 – ~Feb 2020 · 5 months · monthly snapshot~Feb 2020 – ~Apr 2020 · 2 months · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jul 2020 · 2 months · monthly snapshot~Jul 2020 – ~Oct 2020 · 3 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

16 versions recorded

  1. Sep 2025 — Present [monthly]

    Terminated PHASE1/PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE1/PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE1_PHASE2

  5. Oct 2020 — Jan 2021 [monthly]

    Terminated PHASE1_PHASE2

▶ Show 11 earlier versions

  1. Jul 2020 — Oct 2020 [monthly]

    Terminated PHASE1_PHASE2

    Status: Active Not Recruiting → Terminated

  2. May 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  3. Apr 2020 — May 2020 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  4. Feb 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  5. Sep 2019 — Feb 2020 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

  6. Apr 2019 — Sep 2019 [monthly]

    Recruiting PHASE1_PHASE2

  7. Jul 2018 — Apr 2019 [monthly]

    Recruiting PHASE1_PHASE2

  8. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE1_PHASE2

  9. Feb 2018 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

  10. Feb 2017 — Feb 2018 [monthly]

    Recruiting PHASE1_PHASE2

  11. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Jan 2012

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)
  • Prescient Therapeutics, Ltd.
Data source: Prescient Therapeutics, Ltd.

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

Study Locations