Tamoxifen Following Combination Chemotherapy in Treating Women With Operable Invasive Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00002579|
Recruitment Status : Completed
First Posted : August 23, 2004
Last Update Posted : November 6, 2013
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combining combination chemotherapy with hormone therapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without tamoxifen in treating women with stage I or stage II breast cancer that can be surgically removed.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: CMF regimen Drug: cyclophosphamide Drug: fluorouracil Drug: methotrexate Drug: tamoxifen citrate Procedure: conventional surgery Radiation: radiation therapy||Phase 3|
OBJECTIVES: I. Assess the disease-free and overall survival produced by adjuvant tamoxifen given after postoperative chemotherapy with cyclophosphamide/methotrexate/fluorouracil (CMF) vs. adjuvant CMF alone in women with primary breast cancer.
OUTLINE: This is a randomized study. Patients are stratified by age and by participating institution. All patients undergo surgical resection with local radiation therapy, as appropriate. Within 4 weeks of surgery, patients receive cyclophosphamide, methotrexate, and fluorouracil (CMF) every 3 weeks for 6 courses. Radiotherapy is given within 4 weeks of completion of CMF. Before beginning the last course of CMF, patients are randomized to receive either oral tamoxifen daily for 5 years or no further therapy. Patients are followed every 6 months for 5 years, then yearly. Hormone therapy is prohibited except as specified above and except for short-term hormone replacement therapy for severe unresponsive menopausal symptoms.
PROJECTED ACCRUAL: Approximately 2,000 patients will be required. Data on patients entered in Scotland as part of this study will be pooled with data from the EORTC-10901 study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Official Title:||PROTOCOL FOR THE SCOTTISH CHEMO-ENDOCRINE TRIAL D|
|Study Start Date :||March 1993|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002579
|Leicester Royal Infirmary NHS Trust|
|Leicester, England, United Kingdom, LE1 5WW|
|Aberdeen Royal Infirmary|
|Aberdeen, Scotland, United Kingdom, AB25 2ZN|
|Ninewells Hospital and Medical School|
|Dundee, Scotland, United Kingdom, DD1 9SY|
|Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 9NQ|
|Beatson Oncology Centre|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|University of Glasgow|
|Glasgow, Scotland, United Kingdom, G61 1BD|
|Inverness, Scotland, United Kingdom, 1V2 3UJ|
|Royal Alexandra Hospital|
|Paisley, Scotland, United Kingdom|
|Ayr, United Kingdom, KA6 6DX|
|Falkirk Royal Infirmary|
|Falkirk, United Kingdom, FK1 5RE|
|Study Chair:||W.D. George, MD, MS, FRCS||University of Glasgow|