Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

The 50 most recent of 52 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Study completion pushed from Aug 11, 2026 to Jul 16, 2027
    • Eligibility criteria expanded, about 23 words
    • Study description expanded, about 6 words
  2. Study completion date: Aug 14, 2025 to Aug 11, 2026v51
  3. Study completion date: Jun 15, 2025 to Aug 14, 2025v50
  4. Study completion date: Dec 15, 2024 to Jun 15, 2025v49
  5. Study completion date: Dec 15, 2023 to Dec 15, 2024v48
Show 45 earlier versionsHide 45 earlier versions
  1. Study completion date: Jun 15, 2023 to Dec 15, 2023v47
  2. Results first posted: Mar 14, 2023v46 Show 7 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: estimated 105 to confirmed 121
    • Primary completion date changed from estimate of Dec 14, 2021 to Dec 30, 2013
    • Study completion date: Dec 14, 2021 to Jun 15, 2023
    • Start date: Sep 14, 2005 to Sep 27, 2005
    • Interventions: carboplatin (Drug), cyclophosphamide (Drug), docetaxel (Drug), doxorubicin hydrochloride (Drug), paclitaxel (Drug), trastuzumab (Biological) to Carboplatin (Drug), Paclitaxel (Drug), Trastuzumab (Biological), cyclophosphamide (Drug), docetaxel (Drug), doxorubicin hydrochloride (Drug)
    • Secondary endpoints shortened, about 20 words
  3. Primary and study completion dates: Dec 2020 to Dec 14, 2021v45
  4. Primary and study completion dates: Dec 2019 to Dec 2020v44
  5. Primary and study completion dates: Jan 2019 to Dec 2019v43
  6. Study site revisedv42
  7. Re-verified, no change to tracked fieldsv41
  8. Primary and study completion dates: Feb 2018 to Jan 2019v40
  9. Start date: Sep 2005 to Sep 14, 2005v39
  10. Primary completion date: Feb 2017 to Feb 2018
    • Study completion date: Feb 2018
    v38
  11. Primary completion date: Jan 2017 to Feb 2017v37
  12. Re-verified, no change to tracked fieldsv36
  13. Primary completion date: Jan 2016 to Jan 2017v35
  14. Primary completion date: Jan 2015 to Jan 2016v34
  15. Primary completion date: Dec 2014 to Jan 2015v33
  16. Re-verified, no change to tracked fieldsv32
  17. Primary completion date: Dec 2013 to Dec 2014v31
  18. Re-verified, no change to tracked fieldsv30
  19. Primary completion date: Dec 2010 to Dec 2013v29
  20. Lead sponsor: Beckman Research Institute to City of Hope Medical Centerv28 Show 4 more changesShow less
    • Primary completion date: Dec 2009 to Dec 2010
    • Trial status: Recruiting to Active, Not Recruiting
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
  21. Re-verified, no change to tracked fieldsv27
  22. Interventions: carboplatin (Drug), cyclophosphamide (Drug), docetaxel (Drug), doxorubicin hydrochloride (Drug), paclitaxel (Drug), trastuzumab (Drug) to carboplatin (Drug), cyclophosphamide (Drug), docetaxel (Drug), doxorubicin hydrochloride (Drug), paclitaxel (Drug), trastuzumab (Biological)v26
  23. Primary completion date: Dec 2010 to Dec 2009v25
  24. 3 versions Re-verified since Jul 23, 2008, no change to tracked fieldsv22-v24
  25. Interventions: carboplatin (Drug), conventional surgery (Procedure), cyclophosphamide (Drug), docetaxel (Drug), doxorubicin hydrochloride (Drug)… to carboplatin (Drug), cyclophosphamide (Drug), docetaxel (Drug), doxorubicin hydrochloride (Drug), paclitaxel (Drug), trastuzumab (Drug)
    • Study arms: 0 to 3
    v21
  26. Interventions: carboplatin (Drug), chemotherapy (Procedure), conventional surgery (Procedure), cyclophosphamide (Drug), docetaxel (Drug), doxorubicin… to carboplatin (Drug), conventional surgery (Procedure), cyclophosphamide (Drug), docetaxel (Drug), doxorubicin hydrochloride (Drug)…v20
  27. Re-verified, no change to tracked fieldsv19
  28. Primary completion date: Dec 2010v18
  29. Start date: Sep 2005v17
  30. Interventions: Intervention/procedure (Procedure), antibody therapy (Procedure), biological therapy (Procedure), carboplatin (Drug), chemotherapy… to carboplatin (Drug), chemotherapy (Procedure), conventional surgery (Procedure), cyclophosphamide (Drug), docetaxel (Drug), doxorubicin…v16
  31. Interventions: antibody therapy (Procedure), biological therapy (Procedure), carboplatin (Drug), chemotherapy (Procedure), conventional surgery… to Intervention/procedure (Procedure), antibody therapy (Procedure), biological therapy (Procedure), carboplatin (Drug), chemotherapy…v15
  32. 2 versions Re-verified since Sep 18, 2007, no change to tracked fieldsv13-v14
  33. Study Status, Contacts/Locationsv12
  34. Re-verified, no change to tracked fieldsv11
  35. Study Status, Eligibilityv10
  36. 2 versions Re-verified since Dec 4, 2006, no change to tracked fieldsv8-v9
  37. Enrollment target: 105v7
  38. 3 versions Re-verified since May 23, 2006, no change to tracked fieldsv4-v6
  39. Interventions: antibody therapy (Procedure), biological response modifier therapy (Procedure), carboplatin (Drug), chemotherapy (Procedure), conventional… to antibody therapy (Procedure), biological therapy (Procedure), carboplatin (Drug), chemotherapy (Procedure), conventional surgery…v3
  • 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 work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy with or without trastuzumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer. PURPOSE: This randomized phase II trial is comparing two different regimens of combination chemotherapy given together with or without trastuzumab to see how well they work in treating patients with stage II or stage III breast cancer.
Trial Details
NCT Number NCT00295893
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms, Breast Neoplasms, Male, Carcinoma, Ductal, Breast, Carcinoma, Lobular, Inflammatory Breast Neoplasms
Enrollment 121 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov