Condition category
Cancer
Date applied
19/07/2004
Date assigned
10/09/2004
Last edited
04/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof David Cameron

ORCID ID

Contact details

Edinburgh Research Centre
Western General Hospital
Crewe Road South
Edinburgh
EH4 2XR
United Kingdom

Additional identifiers

EudraCT number

2004-000066-13

ClinicalTrials.gov number

NCT00301925

Protocol/serial number

N/A

Study information

Scientific title

Trial of Accelerated Adjuvant Chemotherapy with Capecitabine in Early Breast Cancer

Acronym

TACT2

Study hypothesis

A randomised, phase III clinical trial with a 2 x 2 factorial design addressing two hypotheses:
1. That accelerating Epirubicin will improve the efficacy of the sequential schedules (based originally on the NEAT epirubicin/CMF schedule).
2. That the substitution of CMF by Capecitabine will not be detrimental to patient outcome but will offer advantages in Quality of Life and/or toxicity.

On 19/11/2008 the overall trial end date was changed from 15/10/2008 to 05/12/2008.
Please note as of 28/09/2011 this trial is closed to recruitment with ongoing follow-up.

Ethics approval

Protocol TACT2: Version 1d approved on the 23/09/2005, UK Ethics Committee MREC ref: 04/MRE00/88. Version 3 approved on the 13/05/2008. Current protocol, version 5 approved July 2009.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Early breast cancer

Intervention

Epirubicin followed by cyclophosphamide, methotrexate and 5-fluorouracil (5-FU) (E-CMF)
Accelerated E-CMF
Epi-capecitabine
Accelerated epi-capecitabine

Intervention type

Drug

Phase

Phase III

Drug names

Capecitabine, cyclophosphamide, epirubicin hydrochloride, fluorouracil, methotrexate, pegfilgrastim

Primary outcome measures

Disease-free survival (DFS)

Secondary outcome measures

Overall survival (OS), distant disease-free survival (DDFS), tolerability (including Serious Adverse Events [SAE]), dose-intensity and toxicity, Detailed Toxicity and Quality of Life in the subset of patients studied.

Overall trial start date

15/10/2005

Overall trial end date

01/09/2024

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with early breast cancer for whom treatment with anthracycline chemotherapy is indicated.

1. Histological diagnosis of invasive breast carcinoma
2. Completely resected disease with negative surgical margins (apart from deep margin if full thickness resection).
3. Early stage disease (T0-3 N0-2 M0)with no evidence of distant metastases on routine staging
4. Definite indication for adjuvant chemotherapy
5. ECOG status 0 or 1
6. Aged over 18 years (no upper age limit)
7. Fit to receive any of the trial chemotherapy regimens, with adequate bone marrow, hepatic, and renal function ie:
7.1 Hb > 9g/dL; WBC > 3 ´ 109/L; platelets > 100 x 109/L
7.2 Bilirubin within normal range (unless known Gilbert’s disease)
7.3 AST/ALT = 1.5 x Upper limit of normal (ULN)
7.4 Albumen within normal range
7.5 Creatinine = 1.5 x ULN and calculated creatinine clearance using Cockroft-Gault formula > 50 ml/min
7.6 No active, uncontrolled infection
8. Signed TACT2 trial consent form
9. Randomisation within 8 weeks of surgery, but ideally within 1 month
10. No previous chemotherapy, hormonal therapy or radiotherapy for the treatment of pre-invasive or invasive cancer except:
10.1 Previous radiotherapy for basal cell carcinoma
10.2 Previous pre-operative endocrine therapy provided that there was no evidence of progression during this therapy, that it was for less than 6 weeks in duration, and was stopped at least one month prior to trial entry
11. No previous malignancy except in the case of DCIS, or basal cell carcinoma or cervical carcinoma in situ, or where the patient has been disease-free for 10 years, and where treatment consisted solely of resection.
12. 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
13. No concomitant medical, psychiatric or geographic problems that might prevent completion of treatment or follow-up

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

4400 patients (both male and female)

Participant exclusion criteria

1. Only cytological proof of malignancy
2. No evidence of invasive breast cancer
3. Previous invasive breast cancer or bilateral breast cancer (surgically treated DCIS or LCIS is allowed)
4. Locally advanced breast cancer (T4 and/or N3 disease)
5. Patients who have had breast conserving surgery in whom there is a contra-indication for, or refusal of post-operative radiotherapy
6. Patients with positive surgical margins unless either:
6.1 Deep surgical margin involvement following full thickness resection
6.2 Non-invasive cancer at surgical margins and a decision to perform mastectomy on completion of chemotherapy has already been made
7. Patients not able or willing to give informed consent
8. Patients known not to be available for a minimum of 5 years' follow-up
9. Patients with known serious viral infection such as active Hepatitis B, Hepatitis C or HIV
10. Patients with significant cardiac disease, such as impaired left ventricular function or active angina (requiring regular anti-anginal medication and/or resulting in restricted physical activity)
11. Patients with a history of significant renal impairment or disease
12. Simultaneous participation in the active intervention phase of another treatment trial
13. Being approached and recruited into the active intervention phase of another treatment trial two months before or after recruitment into TACT2

Recruitment start date

01/12/2005

Recruitment end date

05/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Western General Hospital
Edinburgh
EH4 2XR
United Kingdom

Sponsor information

Organisation

The Institute of Cancer Research (UK)

Sponsor details

C/O Prof Alan Ashworth (CEO Institute of Cancer Research)
The Institute of Cancer Research
123 Brompton Road
London
SW7 3RP
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

Industry

Funder name

Cancer Research UK (CRUK) (UK) (ref: C1491/A4858)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Hoffman La-Roche (UK)

Alternative name(s)

Hoffman-La Roche, F. Hoffmann-La Roche Ltd.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Switzerland

Funder name

Amgen Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pfizer Pharmaceuticals (UK)

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

Publication citations

Additional files

Editorial Notes