- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00039546
Combination Chemotherapy in Treating Women With Breast Cancer Who Have Undergone Surgery
'tAnGo', A Phase III Randomised Trial Of Gemcitabine In Paclitaxel-Containing, Epirubicin-Based, Adjuvant Chemotherapy For ER/PgR-Poor, Early Stage, Breast Cancer
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: 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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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East Kilbride, United Kingdom, G75 8RG
- Hairmyres Hospital
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Hull, United Kingdom, HU3 2KZ
- Hull Royal Infirmary
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King's Lynn, United Kingdom, PE30 4ET
- Queen Elizabeth Hospital
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Rhyl, Denbighshire, United Kingdom, LL 18 5UJ
- Glan Clywd District General Hospital
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Swansea, United Kingdom, SA 2 8QA
- Singleton Hospital
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West Glamorgen, United Kingdom, SA6 6NL
- Morriston Hospital NHS Trust
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England
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Birmingham, England, United Kingdom, B15 2TH
- Queen Elizabeth Hospital at University of Birmingham
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Birmingham, England, United Kingdom, B18 7QH
- City Hospital - Birmingham
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Birmingham, England, United Kingdom, B15 2TT
- Cancer Research UK Clinical Trials Unit - Birmingham
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Birmingham, England, United Kingdom, B9 5SS
- Birmingham Heartlands and Solihull NHS Trust -Teaching
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Burton-upon-Trent, England, United Kingdom, DE14 3QH
- Queen's Hospital, Burton
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Cambridge, England, United Kingdom, CB2 2QQ
- Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
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Chelmsford, Essex, England, United Kingdom, CM1 5ET
- Broomfield Hospital
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Colchester, England, United Kingdom, C03 3NB
- Essex County Hospital
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Coventry, England, United Kingdom, CV2 2DX
- Walsgrave Hospital
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Dorchester, England, United Kingdom, DT1 2JY
- Dorset County Hospital
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Exeter, England, United Kingdom, EX2 5DW
- Royal Devon and Exeter Hospital
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Hull, England, United Kingdom, HU8 9HE
- Princess Royal Hospital
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Huntingdon, England, United Kingdom, PE18 6NT
- Hinchingbrooke Hospital
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Ilford, Essex, England, United Kingdom, IG3 8YB
- King George Hospital
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Kilmarnock, England, United Kingdom, KA2 OBE
- Crosshouse Hospital
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Leeds, England, United Kingdom, LS9 7TF
- Leeds Cancer Centre at St. James's University Hospital
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Leeds, England, United Kingdom, LS16 6QB
- Cookridge Hospital at Leeds Teaching Hospital NHS Trust
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London, England, United Kingdom, SW17 0QT
- St. George's Hospital
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Manchester, England, United Kingdom, M20 4BX
- Christie Hospital N.H.S. Trust
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Merseyside, England, United Kingdom, L63 4JY
- Clatterbridge Centre for Oncology NHS Trust
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Middlesbrough, England, United Kingdom, TS4 3BW
- James Cook University Hospital
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Newcastle-upon-Tyne, England, United Kingdom, NE4 6BE
- Northern Centre for Cancer Treatment at Newcastle General Hospital
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Northampton, England, United Kingdom
- Northampton General Hospital NHS Trust
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Nottingham, England, United Kingdom, NG5 1PB
- Nottingham City Hospital NHS Trust
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Peterborough, England, United Kingdom, PE3 6DA
- Peterborough Hospitals Trust
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Plymouth, England, United Kingdom, PL6 8DH
- Derriford Hospital
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Romford, England, United Kingdom, RM7 OBE
- Oldchurch Hospital
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Sheffield, England, United Kingdom, S1O 2SJ
- Cancer Research Centre at Weston Park Hospital
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Sheffield, England, United Kingdom, S10 3BR
- Thornbury Hospital
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Shrewsbury, England, United Kingdom
- Royal Shrewsbury Hospital
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Suffolk, England, United Kingdom, IP33 2QZ
- West Suffolk Hospital
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Torquay Devon, England, United Kingdom, TQ2 7AA
- Torbay Hospital
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Walsall, England, United Kingdom, WS2 9PS
- Walsall Manor Hospital
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West Bromwich, England, United Kingdom, B71 4HJ
- Sandwell General Hospital
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West Midlands, England, United Kingdom, B75 7RR
- Good Hope Hospital Trust
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Worcester, England, United Kingdom, WR5 1JG
- Worcester Royal Hospital
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Scotland
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Edinburgh, Scotland, United Kingdom, EH4 2XU
- Western General Hospital
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Glasgow, Scotland, United Kingdom, G4 0SF
- Royal Infirmary - Castle
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Glasgow, Scotland, United Kingdom, G11 6NT
- Beatson Oncology Centre
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Wales
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Cardiff, Wales, United Kingdom, CF4 7XL
- Velindre Cancer Center at Velinde Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Investigators
- Study Chair: Helen Howard, PhD, Cancer Research Campaign Clinical Trials Centre
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Gemcitabine
- Cyclophosphamide
- Paclitaxel
- Epirubicin
Other Study ID Numbers
- CRC-TU-TANGO
- CDR0000069396 (Registry Identifier: PDQ (Physician Data Query))
- EU-20058
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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