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ISRCTN
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ISRCTN51146252
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ClinicalTrials.gov identifier
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Public title
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A randomised phase III trial of gemcitabine in paclitaxel-containing, epirubicin-based, adjuvant chemotherapy for women with early stage breast cancer
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Scientific title
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Acronym
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TANGO
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Serial number at source
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N/A
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Study hypothesis
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In women with early stage breast cancer, the addition of gemcitabine to paclitaxel-containing, epirubicin-based, adjuvant chemotherapy provides significantly superior disease-free and overall survival, without excess toxicity or prolonged adverse impact on quality of life.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Breast cancer
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Participants - inclusion criteria
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1. Histological diagnosis of invasive breast carcinoma
2. Completely resected early stage disease
3. Definite indication for adjuvant chemotherapy
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Any nodal status
5. Any hormone receptor status
6. Fit to receive either of the trial chemotherapy regimens. Adequate bone marrow, hepatic, and renal function.
7. Eastern Cooperative Oncology Group (ECOG) performance status of zero to two
8. Written informed consent
9. No previous chemotherapy or radiotherapy
10. Radiotherapy intent is known (this must be stated at the point of randomisation)
11. Randomisation within eight weeks of surgery, but ideally within one month
12. No previous malignancy except basal cell carcinoma or cervical carcinoma in situ, unless disease-free for ten years, after surgical treatment only
13. Non-pregnant and non-lactating, with no intention of pregnancy during chemotherapy, and prepared to adopt adequate contraceptive measures if pre-menopausal and sexually active
14. No concomitant medical or psychiatric problems that might prevent completion of treatment or follow-up
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Participants - exclusion criteria
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Any of the above criteria not satisfied
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Anticipated start date
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22/08/2001
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Anticipated end date
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26/11/2004
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Status of trial
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Completed
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Patient information material
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Target number of participants
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3152
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Interventions
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Control Arm: Epirubicin 90 mg/m^2 (day one) + Cyclophosphamide 600 mg/m^2 (day one); four cycles, three weekly intervals followed by Paclitaxel 175 mg/m^2 (day one); four cycles at three weekly intervals.
Research Arm: Epirubicin 90 mg/m^2 (day one) + Cyclophosphamide 600 mg/m^2 (day one); four cycles at three weekly intervals followed by Gemcitabine 1250 mg/m^2 (days one and eight) + Paclitaxel 175 mg/m^2 (day one); four cycles at three weekly intervals.
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Primary outcome measure(s)
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Five year disease-free survival.
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Secondary outcome measure(s)
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Ten year overall survival, toxicity, dose intensity, tolerability & serious adverse events.
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Sources of funding
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Bristol Myers-Squibb
Pharmacia and Upjohn
Eli Lilly
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Trial website
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Publications
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Contact name
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Mrs
Shrushma
Loi
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Address
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CRUK Clinical Trials Unit
Institute for Cancer Studies
The University of Birmingham
Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Tel
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+44 (0)121 414 3789
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Fax
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+44 (0)121 414 3700
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Email
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tango@trials.bham.ac.uk
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Sponsor
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The University of Birmingham (UK)
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Address
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Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Tel
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+44 (0)121 414 7618
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Email
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Date applied
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01/07/2001
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Last edited
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18/08/2006
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Date ISRCTN assigned
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01/07/2001
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