Contact information
Type
Scientific
Primary contact
Mrs Shrushma Loi
ORCID ID
Contact details
CRUK Clinical Trials Unit
Institute for Cancer Studies
The University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 3789
tango@trials.bham.ac.uk
Additional identifiers
EudraCT number
2004-002927-41
ClinicalTrials.gov number
NCT00039546
Protocol/serial number
N/A
Study information
Scientific title
A randomised phase III trial of gemcitabine in paclitaxel-containing, epirubicin-based, adjuvant chemotherapy for women with early stage breast cancer
Acronym
TANGO
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Breast cancer
Intervention
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.
Intervention type
Drug
Phase
Phase III
Drug names
Epirubicin, cyclophosphamide, paclitaxel, gemcitabine
Primary outcome measures
Five-year disease-free survival
Secondary outcome measures
Ten-year overall survival, toxicity, dose intensity, tolerability and serious adverse events
Overall trial start date
22/08/2001
Overall trial end date
26/11/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Histological diagnosis of invasive breast carcinoma
2. Completely resected early stage disease
3. Definite indication for adjuvant chemotherapy
4. 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
3152
Participant exclusion criteria
Any of the above criteria not satisfied
Recruitment start date
22/08/2001
Recruitment end date
26/11/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
CRUK Clinical Trials Unit
Birmingham
B15 2TT
United Kingdom
Funders
Funder type
Industry
Funder name
Bristol Myers-Squibb
Alternative name(s)
Bristol-Myers Squibb Company, BMS
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Funder name
Pharmacia and Upjohn
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Eli Lilly and Company
Alternative name(s)
Lilly
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2008 safety substudy results in: http://www.ncbi.nlm.nih.gov/pubmed/18665163
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28479233
Publication citations
-
Safety substudy results
Wardley AM, Hiller L, Howard HC, Dunn JA, Bowman A, Coleman RE, Fernando IN, Ritchie DM, Earl HM, Poole CJ, , tAnGo: a randomised phase III trial of gemcitabine in paclitaxel-containing, epirubicin/cyclophosphamide-based, adjuvant chemotherapy for early breast cancer: a prospective pulmonary, cardiac and hepatic function evaluation., Br. J. Cancer, 2008, 99, 4, 597-603, doi: 10.1038/sj.bjc.6604538.