Combination Chemotherapy in Treating Women With Breast Cancer Who Have Undergone Surgery
NCT ID: NCT00039546
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
INTERVENTIONAL
2001-08-31
Brief Summary
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PURPOSE: Randomized phase 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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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cyclophosphamide
epirubicin hydrochloride
gemcitabine hydrochloride
paclitaxel
adjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Cancer Research Campaign Clinical Trials Centre
OTHER
Principal Investigators
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Helen Howard, PhD
Role: STUDY_CHAIR
Cancer Research Campaign Clinical Trials Centre
Locations
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Queen Elizabeth Hospital at University of Birmingham
Birmingham, England, United Kingdom
Cancer Research UK Clinical Trials Unit - Birmingham
Birmingham, England, United Kingdom
City Hospital - Birmingham
Birmingham, England, United Kingdom
Birmingham Heartlands and Solihull NHS Trust -Teaching
Birmingham, England, United Kingdom
Queen's Hospital, Burton
Burton-on-Trent, England, United Kingdom
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom
Broomfield Hospital
Chelmsford, Essex, England, United Kingdom
Essex County Hospital
Colchester, England, United Kingdom
Walsgrave Hospital
Coventry, England, United Kingdom
Dorset County Hospital
Dorchester, England, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
Princess Royal Hospital
Hull, England, United Kingdom
Hinchingbrooke Hospital
Huntingdon, England, United Kingdom
King George Hospital
Ilford, Essex, England, United Kingdom
Crosshouse Hospital
Kilmarnock, England, United Kingdom
Cookridge Hospital at Leeds Teaching Hospital NHS Trust
Leeds, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
St. George's Hospital
London, England, United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom
James Cook University Hospital
Middlesbrough, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Northampton General Hospital NHS Trust
Northampton, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Peterborough Hospitals Trust
Peterborough, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Oldchurch Hospital
Romford, England, United Kingdom
Thornbury Hospital
Sheffield, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, England, United Kingdom
West Suffolk Hospital
Suffolk, England, United Kingdom
Torbay Hospital
Torquay Devon, England, United Kingdom
Walsall Manor Hospital
Walsall, England, United Kingdom
Sandwell General Hospital
West Bromwich, England, United Kingdom
Good Hope Hospital Trust
West Midlands, England, United Kingdom
Worcester Royal Hospital
Worcester, England, United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom
Royal Infirmary - Castle
Glasgow, Scotland, United Kingdom
Velindre Cancer Center at Velinde Hospital
Cardiff, Wales, United Kingdom
Hairmyres Hospital
East Kilbride, , United Kingdom
Hull Royal Infirmary
Hull, , United Kingdom
Queen Elizabeth Hospital
Kings Lynn, , United Kingdom
Glan Clywd District General Hospital
Rhyl, Denbighshire, , United Kingdom
Singleton Hospital
Swansea, , United Kingdom
Morriston Hospital NHS Trust
West Glamorgen, , United Kingdom
Countries
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References
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Earl HM, Hiller L, Howard HC, Dunn JA, Young J, Bowden SJ, McDermaid M, Waterhouse AK, Wilson G, Agrawal R, O'Reilly S, Bowman A, Ritchie DM, Goodman A, Hickish T, McAdam K, Cameron D, Dodwell D, Rea DW, Caldas C, Provenzano E, Abraham JE, Canney P, Crown JP, Kennedy MJ, Coleman R, Leonard RC, Carmichael JA, Wardley AM, Poole CJ; tAnGo trial collaborators. Addition of gemcitabine to paclitaxel, epirubicin, and cyclophosphamide adjuvant chemotherapy for women with early-stage breast cancer (tAnGo): final 10-year follow-up of an open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):755-769. doi: 10.1016/S1470-2045(17)30319-4. Epub 2017 May 4.
Other Identifiers
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CDR0000069396
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20058
Identifier Type: -
Identifier Source: secondary_id
CRC-TU-TANGO
Identifier Type: -
Identifier Source: org_study_id