Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Dec 29, 2025 to Nov 6, 2025
    v30
  2. Study completion date: Dec 30, 2024 to Dec 29, 2025v29
  3. Study completion date: Dec 30, 2023 to Dec 30, 2024v28
  4. Primary completion date changed from estimate of Dec 30, 2022 to Feb 9, 2010
    • Study completion date: Dec 30, 2022 to Dec 30, 2023
    v27
  5. Primary and study completion dates: Dec 30, 2021 to Dec 30, 2022v26
Show 24 earlier versionsHide 24 earlier versions
  1. Re-verified, no change to tracked fieldsv25
  2. Results first posted: Apr 8, 2021
    • Primary endpoints: 3 to 2
    • Enrollment target: estimated 60 to confirmed 41
    v24
  3. Primary and study completion dates: Dec 2019 to Dec 30, 2021
    • Start date: May 1997 to May 30, 1997
    v23
  4. Primary and study completion dates: Mar 2019 to Dec 2019v22
  5. Primary and study completion dates: Sep 2018 to Mar 2019v21
  6. Primary completion date: Sep 2017 to Sep 2018
    • Study completion date: Sep 2018
    v20
  7. Primary completion date: Jul 2016 to Sep 2017v19
  8. Primary completion date: Mar 2016 to Jul 2016v18
  9. Primary completion date: Mar 2014 to Mar 2016
    • Study arms: 0 to 2
    v17
  10. Primary completion date: Mar 2013 to Mar 2014v16
  11. Primary completion date: Oct 2012 to Mar 2013v15
  12. Primary completion date: Oct 2012v14
  13. Lead sponsor: Beckman Research Institute to City of Hope Medical Centerv13
  14. Interventions: bone marrow ablation with stem cell support (Procedure), cisplatin (Drug), conventional surgery (Procedure), cyclophosphamide (Drug)… to bone marrow ablation with stem cell support (Procedure), cisplatin (Drug), conventional surgery (Procedure), cyclophosphamide (Drug)…v12
  15. Re-verified, no change to tracked fieldsv11
  16. Interventions: bone marrow ablation with stem cell support (Procedure), chemotherapy (Procedure), cisplatin (Drug), colony-stimulating factor therapy… to bone marrow ablation with stem cell support (Procedure), cisplatin (Drug), conventional surgery (Procedure), cyclophosphamide (Drug)…v10
  17. Re-verified, no change to tracked fieldsv9
  18. Interventions: biological therapy (Procedure), bone marrow ablation with stem cell support (Procedure), chemotherapy (Procedure), cisplatin (Drug)… to bone marrow ablation with stem cell support (Procedure), chemotherapy (Procedure), cisplatin (Drug), colony-stimulating factor therapy…v8
  19. Enrollment target: 60
    • Start date: May 1997
    v7
  20. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v6
  21. Interventions: biological response modifier therapy (Procedure), bone marrow ablation with stem cell support (Procedure), chemotherapy (Procedure)… to biological therapy (Procedure), bone marrow ablation with stem cell support (Procedure), chemotherapy (Procedure), cisplatin (Drug)…v5
  22. Interventions: biological response modifier therapy (Procedure), bone marrow ablation with stem cell support (Procedure), chemotherapy (Procedure)… to biological response modifier therapy (Procedure), bone marrow ablation with stem cell support (Procedure), chemotherapy (Procedure)…v4
  23. Interventions: biological response modifier therapy (Procedure), bone marrow ablation with stem cell support (Procedure), chemotherapy (Procedure)… to biological response modifier therapy (Procedure), bone marrow ablation with stem cell support (Procedure), chemotherapy (Procedure)…v3
  24. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase II trial is studying how well chemotherapy and stem cell transplantation work in treating patients with stage IIIB breast cancer.
Trial Details
NCT Number NCT00003042
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms, Inflammatory Breast Neoplasms
Enrollment 41 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov