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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Women With Breast Cancer Who Have Undergone Surgery  Combination Chemotherapy in Treating Women With Breast Cancer Who Have Undergone Surgery
Combination Chemotherapy in Treating Women With Breast Cancer Who Have Undergone Surgery
For Condition: stage 1 breast cancer,stage 2 breast cancer
Status: Recruiting
Sponsor(s): Cancer Research Campaign Clinical Trials Centre ,
Synopsis: 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. It is not yet known which chemotherapy regimen is more effective in treating women after surgery for breast cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of paclitaxel, epirubicin, and cyclophosphamide with or without gemcitabine in treating women who have undergone surgery for breast cancer.
Details: OBJECTIVES: - Compare the 5-year and 10-year disease-free survival and overall survival of women with completely resected early stage breast cancer treated with adjuvant paclitaxel, epirubicin, and cyclophosphamide with or without gemcitabine. - Compare the toxicity, dose-intensity, and tolerability of these regimens in these patients. - Compare the serious adverse events in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to nodal status (negative vs 1-3 vs 4 or more), age (50 and under vs over 50), estrogen receptor status (negative vs weakly positive vs positive), concurrent radiotherapy (no vs yes), HER2 status (3+ overexpression vs other vs not measured), and country. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive epirubicin IV, cyclophosphamide IV, and paclitaxel IV over 3 hours on day 1. Patients also receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive epirubicin, cyclophosphamide, and paclitaxel as in arm I. Patients are followed every 3 months for 6 months, every 6 months for 3 years, and then annually for 6 years. PROJECTED ACCRUAL: A total of 3,000 patients (1,500 per treatment arm) will be accrued for this study within 3-4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed newly diagnosed invasive breast cancer - Early stage disease - Completely resected disease - No more than 8 weeks since prior resection - Any nodal status - Indication for adjuvant chemotherapy - No metastatic disease - Hormone receptor status: - Estrogen receptor negative or weakly positive OR - Estrogen receptor positive AND progesterone receptor negative or weakly positive PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - Not specified Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC greater than 3,000/mm3 - Platelet count greater than 100,000/mm3 - Hemoglobin greater than 9 g/dL Hepatic: - Bilirubin normal - AST and ALT no greater than 1.5 times normal Renal: - Creatinine no greater than 1.5 times normal Other: - Fit to receive study chemotherapy - No active uncontrolled infection - No other malignancy within the past 10 years except basal cell carcinoma or carcinoma in situ of the cervix - No other concurrent medical or psychiatric problems that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HelenHoward, Study Chair, Cancer Research Campaign Clinical Trials Centre
Birmingham Heartlands and Solihull NHS Trust -Teaching *Recruiting*
Birmingham, England, B9 5SS
United Kingdom
Recruiting Contact Person 0121 424200
Royal Infirmary *Recruiting*
Glasgow, Scotland, G4 0SF
United Kingdom
Recruiting Contact Person 0141 2114000
Addenbrooke's NHS Trust *Recruiting*
Cambridge, England, CB2 2QQ
United Kingdom
Recruiting Contact Person 01233 245151
Nottingham City Hospital NHS Trust *Recruiting*
Nottingham, England, NG5 1PB
United Kingdom
Recruiting Contact Person 0115 969 1169
Northern Centre for Cancer Treatment at Newcastle General Hospital *Recruiting*
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Recruiting Contact Person 0191 281 8811
Queen Elizabeth Hospital *Recruiting*
King's Lynn, , PE30 4ET
United Kingdom
Recruiting Contact Person 01553 613613
Peterborough Hospitals Trust *Recruiting*
Peterborough, England, PE3 6DA
United Kingdom
Recruiting Contact Person 01733 874000
Weston Park Hospital *Recruiting*
Sheffield, England, S1O 2SJ
United Kingdom
Recruiting Contact Person 0114 226 5000
Hull Royal Infirmary *Recruiting*
Hull, , HU3 2KZ
United Kingdom
Recruiting Contact Person 01482 328541
Glan Clywd District General Hospital *Recruiting*
Rhyl, Denbighshire, , LL 18 5UJ
United Kingdom
Recruiting Contact Person 01745 583910
Royal Devon and Exeter Hospital *Recruiting*
Exeter, England, EX2 5DW
United Kingdom
Recruiting Contact Person 01392 411611
Northampton General Hospital NHS Trust *Recruiting*
Northampton, England,
United Kingdom
Recruiting Contact Person 0115 969 1169
City Hospital - Birmingham *Recruiting*
Birmingham, England, B18 7QH
United Kingdom
Recruiting Contact Person 0121 5543801
Beatson Oncology Centre *Recruiting*
Glasgow, Scotland, G11 6NT
United Kingdom
Recruiting Contact Person 0141 211 2000
Broomfield Hospital *Recruiting*
Chelmsford, Essex, England, CM1 5ET
United Kingdom
Recruiting Contact Person 01245440761
King George Hospital *Recruiting*
Ilford, Essex, England, IG3 8YB
United Kingdom
Recruiting Contact Person 020 8983 8000
St. George's Hospital *Recruiting*
London, England, SW17 0QT
United Kingdom
Recruiting Contact Person 020 5672 1255
Torbay Hospital *Recruiting*
Torquay Devon, England, TQ2 7AA
United Kingdom
Recruiting Contact Person 01803 614567
Walsall Manor Hospital *Recruiting*
Walsall, England, WS2 9PS
United Kingdom
Recruiting Contact Person 01922 721172
Christie Hospital N.H.S. Trust *Recruiting*
Manchester, England, M20 4BX
United Kingdom
Recruiting Contact Person 0161 4463000
Worcester Royal Infirmary *Recruiting*
Worcester, England, WR5 1JG
United Kingdom
Recruiting Contact Person 01905 76333
Western General Hospital *Recruiting*
Edinburgh, Scotland, EH4 2XU
United Kingdom
Recruiting Contact Person 0131 537 1000
Sandwell & West Birminghan NHS Trust *Recruiting*
West Bromwich, England, B71 4HJ
United Kingdom
Recruiting Contact Person 0121 553 1831
Thornbury Hospital *Recruiting*
Sheffield, England, S10 3BR
United Kingdom
Recruiting Contact Person 01803 614567
Dorset County Hospital *Recruiting*
Dorchester, England, DT1 2JY
United Kingdom
Recruiting Contact Person 01305 251150
Cancer Research UK Clinical Trials Unit - Birmingham *Recruiting*
Birmingham, England, B15 2TT
United Kingdom
Recruiting Helen Howard 44-121-414-3787
Clatterbridge Centre for Oncology NHS Trust *Recruiting*
Merseyside, England, L63 4JY
United Kingdom
Recruiting Contact Person 0151 3341155
Walsgrave Hospital *Recruiting*
Coventry, England, CV2 2DX
United Kingdom
Recruiting Contact Person 024 7660 2020
Hinchingbrooke Hospital *Recruiting*
Huntingdon, England, PE18 6NT
United Kingdom
Recruiting Contact Person 01480 416416
West Suffolk Hospital *Recruiting*
Suffolk, England, IP33 2QZ
United Kingdom
Recruiting Contact Person 01284 713000
Princess Royal Hospital *Recruiting*
Hull, England, HU8 9HE
United Kingdom
Recruiting Contact Person 01482 701151
Crosshouse Hospital *Recruiting*
Kilmarnock, England, KA2 OBE
United Kingdom
Recruiting Contact Person 01563 521133
Good Hope Hospital Trust *Recruiting*
West Midlands, England, B75 7RR
United Kingdom
Recruiting Contact Person 0121 3782211
Essex County Hospital *Recruiting*
Colchester, England, C03 3NB
United Kingdom
Recruiting Contact Person 01206 747474
Singleton Hospital *Recruiting*
Swansea, , SA 2 8QA
United Kingdom
Recruiting Contact Person 01792 205666
Derriford Hospital *Recruiting*
Plymouth, England, PL6 8DH
United Kingdom
Recruiting Contact Person 01752 777111
Hairmyres Hospital *Recruiting*
East Kilbride, , G75 8RG
United Kingdom
Recruiting Contact Person 01355 220292
James Cook University Hospital *Recruiting*
Middlesbrough, England, TS4 3BW
United Kingdom
Recruiting Contact Person 01642 850850
Royal Shrewsbury Hospital *Recruiting*
Shrewsbury, England,
United Kingdom
Recruiting Contact Person 01743 261000
Morriston Hospital NHS Trust *Recruiting*
West Glamorgen, , SA6 6NL
United Kingdom
Recruiting Contact Person 01792 70222
Queen Elizabeth Hospital at University of Birmingham *Recruiting*
Birmingham, England, B15 2TH
United Kingdom
Recruiting Contact Person 0121 4721311
Oldchurch Hospital *Recruiting*
Romford, England, RM7 OBE
United Kingdom
Recruiting Contact Person 01708 746090
St. James's University Hospital *Recruiting*
Leeds, England, LS9 7TF
United Kingdom
Recruiting Contact Person 0113 243 3144
Queen's Hospital, Burton *Recruiting*
Burton upon Trent, England, DE14 3QH
United Kingdom
Recruiting Contact Person 01283 566333
Cookridge Hospital at Leeds Teaching Hospital NHS Trust *Recruiting*
Leeds, England, LS16 6QB
United Kingdom
Recruiting Contact Person 0113 2673411
Velindre Cancer Center at Velinde Hospital *Recruiting*
Cardiff, Wales, CF4 7XL
United Kingdom
Recruiting Contact Person 029 2061 5888
Additional Information:
Study ID Numbers: CDR0000069396; CRC-TU-TANGO,EU-20058
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039546
Other Stage 2 Breast Cancer Studies:
1. Tamoxifen in Treating Women With Breast Cancer
2. Axillary Drainage Following Lymph Node Dissection in Women With Stage I or Stage II Breast Cancer
3. Chemotherapy in Treating Women Enrolled in the SWOG-8897 Clinical Trial
4. Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer
5. Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
Related Studies:
Other stage 2 breast cancer Clinical Trials
Other England Clinical Trials
Other Cambridge Clinical Trials
Combination Chemotherapy in Treating Women With Breast Cancer Who Have Undergone Surgery
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