Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
16/12/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Not specified

Trial type

Treatment

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

Other

Phase

Phase III

Drug names

Primary outcome measures

Five year disease-free survival.

Secondary outcome measures

Ten year overall survival, toxicity, dose intensity, tolerability & 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

Sponsor information

Organisation

The University of Birmingham (UK)

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 7618

Sponsor type

University/education

Website

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2008 safety substudy results in http://www.ncbi.nlm.nih.gov/pubmed/18665163

Publication citations

  1. 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.

Additional files

Editorial Notes