Plain English Summary
Study website
Additional identifiers
EudraCT/CTIS number
2004-000066-13
IRAS number
ClinicalTrials.gov number
NCT00301925
Secondary identifying numbers
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.
Ethics approval(s)
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
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a 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
Pharmaceutical study type(s)
Phase
Phase III
Drug/device/biological/vaccine name(s)
Capecitabine, cyclophosphamide, epirubicin hydrochloride, fluorouracil, methotrexate, pegfilgrastim
Primary outcome measure
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 study start date
15/10/2005
Overall study end date
01/09/2024
Reason abandoned (if study stopped)
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 Gilberts 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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
4400 patients (both male and female)
Total final enrolment
4391
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
Scotland, United Kingdom
Study participating centre
Western General Hospital
Edinburgh
EH4 2XR
United Kingdom
Sponsor information
Organisation
The Institute of Cancer Research (UK)
Sponsor details
The Institute of Cancer Research
123 Brompton Road
London
SW7 3RP
United Kingdom
Sponsor type
Research organisation
Website
ROR
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 organizations
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
For-profit companies (industry)
Location
Switzerland
Funder name
Amgen Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Pfizer UK
Alternative name(s)
Pfizer Ltd
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) Intention to share
No
IPD sharing plan
Not provided at time of registration
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2017 | Yes | No | |
| Plain English results | 26/10/2022 | No | Yes | ||
| Results article | 02/11/2023 | 06/11/2023 | Yes | No |