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 |
| EudraCT/CTIS number | 2004-002927-41 |
| ClinicalTrials.gov number | NCT00039546 |
| Secondary identifying numbers | N/A |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Epirubicin, cyclophosphamide, paclitaxel, gemcitabine |
| Primary outcome measure | Five-year disease-free survival |
| Secondary outcome measures | Ten-year overall survival, toxicity, dose intensity, tolerability and serious adverse events |
| Overall study start date | 22/08/2001 |
| Completion date | 26/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
CRUK Clinical Trials Unit
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
The University of Birmingham (UK)
University/education
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
"ROR" |
https://ror.org/03angcq70 |
|---|
Funders
Funder type
Industry
Bristol Myers-Squibb
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Bristol-Myers Squibb Company, BMS
- Location
- United States of America
Pharmacia and Upjohn
No information available
Eli Lilly and Company
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Lilly, Eli Lilly & Company, Eli Lilly & Co., Eli Lilly And Co
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | safety substudy results | 19/08/2008 | Yes | No | |
| Results article | results | 01/06/2017 | Yes | No |
Editorial Notes
17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
10/05/2017: Publication reference added.
