Combination Chemotherapy With or Without Fluorouracil and/or Pegfilgrastim in Treating Women With Node-Positive Breast Cancer

StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

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  1. Study completion date: Dec 2025 to Dec 2027v16
  2. Re-verified, no change to tracked fieldsv15
  3. Study completion date: Dec 2022 to Dec 2025v14
  4. Study completion date: Dec 2020 to Dec 2022v13
  5. Lead sponsor: Gruppo Italiano Mammella (GIM) to IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
    • Primary completion date: May 2006
    • Study completion date: Dec 2020
    • Collaborators expanded, about 4 words
    v12
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  1. 2 versions Re-verified since Jul 31, 2013, no change to tracked fieldsv10-v11
  2. Interventions: adjuvant therapy (Procedure), cyclophosphamide (Drug), epirubicin hydrochloride (Drug), fluorouracil (Drug), paclitaxel (Drug)… to adjuvant therapy (Procedure), cyclophosphamide (Drug), epirubicin hydrochloride (Drug), fluorouracil (Drug), paclitaxel (Drug)…v9
  3. Re-verified, no change to tracked fieldsv8
  4. Interventions: adjuvant therapy (Procedure), chemotherapy (Procedure), colony-stimulating factor therapy (Procedure), cyclophosphamide (Drug), epirubicin… to adjuvant therapy (Procedure), cyclophosphamide (Drug), epirubicin hydrochloride (Drug), fluorouracil (Drug), paclitaxel (Drug)…v7
  5. Re-verified, no change to tracked fieldsv6
  6. Interventions: adjuvant therapy (Procedure), biological therapy (Procedure), chemotherapy (Procedure), colony-stimulating factor therapy (Procedure)… to adjuvant therapy (Procedure), chemotherapy (Procedure), colony-stimulating factor therapy (Procedure), cyclophosphamide (Drug), epirubicin…v5
  7. 2 versions Re-verified since Feb 20, 2007, no change to tracked fieldsv3-v4
  8. Study description shortened, about 14 words
    • Eligibility criteria expanded, about 2 words
    • Study title shortened, about 2 words
    v2
  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, such as epirubicin, cyclophosphamide, paclitaxel, and fluorouracil, 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. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy and pegfilgrastim after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective with or without fluorouracil and/or pegfilgrastim in treating breast cancer. PURPOSE: This randomized phase III trial is studying combination chemotherapy to compare how well it works when given with or without fluorouracil and/or pegfilgrastim in treating women with node-positive breast cancer.
Trial Details
NCT Number NCT00433420
Lead Sponsor IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Collaborators: Gruppo Italiano Mammella (GIM)
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov