A randomised phase III trial of gemcitabine in paclitaxel-containing, epirubicin-based, adjuvant chemotherapy for women with early stage breast cancer
| ISRCTN | ISRCTN51146252 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51146252 |
| ClinicalTrials.gov (NCT) | NCT00039546 |
| Clinical Trials Information System (CTIS) | 2004-002927-41 |
| Protocol serial number | N/A |
| Sponsor | The University of Birmingham (UK) |
| Funders | Bristol Myers-Squibb, Pharmacia and Upjohn, Eli Lilly and Company |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 17/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Shrushma Loi
Scientific
Scientific
CRUK Clinical Trials Unit
Institute for Cancer Studies
The University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 414 3789 |
|---|---|
| tango@trials.bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised phase III trial of gemcitabine in paclitaxel-containing, epirubicin-based, adjuvant chemotherapy for women with early stage breast cancer |
| Study acronym | TANGO |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Epirubicin, cyclophosphamide, paclitaxel, gemcitabine |
| Primary outcome measure(s) |
Five-year disease-free survival |
| Key secondary outcome measure(s) |
Ten-year overall survival, toxicity, dose intensity, tolerability and serious adverse events |
| Completion date | 26/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 3152 |
| Key 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 |
| Key exclusion criteria | Any of the above criteria not satisfied |
| Date of first enrolment | 22/08/2001 |
| Date of final enrolment | 26/11/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
CRUK Clinical Trials Unit
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | safety substudy results | 19/08/2008 | Yes | No | |
| Results article | results | 01/06/2017 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes |
Editorial Notes
17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
10/05/2017: Publication reference added.
