Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
01/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.icr.ac.uk/research/research_sections/clinical_trials/clinical_trials_list/2415.shtml

Contact information

Type

Scientific

Primary contact

Mrs Deborah Coward

ORCID ID

Contact details

Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Section of Epidemiology
Brookes Lawley Building
Cotswold Road
Sutton
Surrey
SM2 5NG
United Kingdom
+44 (0)208 722 4299
Tact-icrctsu@icr.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00033683

Protocol/serial number

N/A

Study information

Scientific title

Acronym

TACT

Study hypothesis

Not provided at time of registration

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breast cancer

Intervention

Control Arm A: 5- Fluorouracil (5-FU) (600 mg/m^2 intravenous [iv] bolus), Epirubicin (60 mg/m^2 iv bolus), Cyclophosphamide (600 mg/m^2 iv bolus) x eight cycles at three weekly intervals.

Control Arm B: Epirubicin (100 mg/m^2 iv bolus) x four cycles at three weekly intervals followed by Cyclophosphamide 100 mg/m^2 orally days one to 14 OR 600 mg/m^2 iv bolus days one, eight, Methotrexate 40 mg/m^2 iv bolus days one, eight, 5-FU 600 mg/m^2 iv bolus days one, eight x four cycles at four weekly intervals.

Study Arm: Docetaxel (100 mg/m^2) as one hour infusion for four cycles at three weekly intervals.

Intervention type

Drug

Phase

Not Specified

Drug names

Anthracycline-based chemotherapy with fluorouracil, epirubicin and cyclophosphamide (FEC) or epirubicin and cyclophosphamide, methotrexate and 5-fluorouracil (CMF)

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

20/05/2001

Overall trial end date

01/07/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with operable histologically confirmed completely resected invasive breast cancer for whom adjuvant chemotherapy is indicated
2. No clinical or radiological evidence of locoregional or metastatic disease based on standard staging procedures at local centres
3. World Health Organisation (WHO) performance status of zero or one
4. Chemotherapy to start within eight weeks from date of definitive surgery
5. Aged over 18 years (no upper age limit)
6. Hormone receptor status to be determined prior to randomisation
7. Adequate renal, hepatic and bone marrow function
8. Signed written informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

3340

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

20/05/2001

Recruitment end date

01/07/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Sutton, Surrey
SM2 5NG
United Kingdom

Sponsor information

Organisation

Sponsor not defined - Record supplied by Institute of Cancer Research

Sponsor details

c/o Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Section of Epidemiology
Brookes Lawley Building
Cotswold Road
Sutton
Surrey
SM2 5NG
United Kingdom

Sponsor type

Research organisation

Website

http://www.ctu.mrc.ac.uk/ukcccr/home.html

Funders

Funder type

Charity

Funder name

Cancer Research UK (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19447249

Publication citations

  1. Results

    Ellis P, Barrett-Lee P, Johnson L, Cameron D, Wardley A, O'Reilly S, Verrill M, Smith I, Yarnold J, Coleman R, Earl H, Canney P, Twelves C, Poole C, Bloomfield D, Hopwood P, Johnston S, Dowsett M, Bartlett JM, Ellis I, Peckitt C, Hall E, Bliss JM, , , Sequential docetaxel as adjuvant chemotherapy for early breast cancer (TACT): an open-label, phase III, randomised controlled trial., Lancet, 2009, 373, 9676, 1681-1692, doi: 10.1016/S0140-6736(09)60740-6.

Additional files

Editorial Notes