Comparison of Three Combination Chemotherapy Regimens in Treating Women With Stage I or Stage II Breast Cancer
|ClinicalTrials.gov Identifier: NCT00004237|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : November 6, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying three regimens of combination chemotherapy to compare how well they work in treating women with stage I or stage II breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Drug: mitoxantrone hydrochloride Drug: vinorelbine tartrate Procedure: conventional surgery Radiation: radiation therapy||Phase 2|
- Determine the efficacy of vinorelbine/epirubicin and vinorelbine/mitoxantrone in terms of clinical objective tumor response, clinical complete remission, and pathological complete remission in women with early stage breast cancer.
- Compare the efficacy of these 2 new regimens with an established regimen of cyclophosphamide/doxorubicin in a randomly selected control group of patients.
- Compare the toxicity and side effects of these 2 new regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to center and age (under 50 vs 50 and over). Patients are randomized to one of three treatment arms.
- Arm I: Patients receive vinorelbine IV on days 1 and 8 and epirubicin IV on day 1.
- Arm II: Patients receive vinorelbine IV on days 1 and 8 and mitoxantrone IV on day 1.
- Arm III: Patients receive doxorubicin IV and cyclophosphamide IV on day 1. Treatment continues every 3 weeks for 6 courses in the absence of unacceptable toxicity or disease progression. All patients except those who are under 50 and whose tumors are estrogen receptor negative receive oral adjuvant tamoxifen daily in addition to chemotherapy.
All patients are offered surgery following completion of chemotherapy. Radiotherapy begins within 4 weeks of completion of chemotherapy or surgery, whichever is the immediately preceding treatment.
Patients are followed every 3 months for the first 2 years, every 6 months for the next 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 62-125 patients will be accrued for this study within 12-18 months.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Trial of Navelbine/Epirubicin Versus Navelbine/Mitozantrone Versus Cyclophosphamide/Adriamycin as Preoperative Chemotherapy in Patients With > or = 3cm Diameter Early Breast Cancer|
|Study Start Date :||October 1998|
|Study Completion Date :||September 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004237
|Royal Marsden NHS Foundation Trust - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Study Chair:||Ian E. Smith, MD||Royal Marsden NHS Foundation Trust|