Trial of accelerated adjuvant chemotherapy with capecitabine in early breast cancer

ISRCTN	ISRCTN68068041
DOI	https://doi.org/10.1186/ISRCTN68068041
EudraCT/CTIS number	2004-000066-13
ClinicalTrials.gov number	NCT00301925
Secondary identifying numbers	N/A

Submission date: 19/07/2004
Registration date: 10/09/2004
Last edited: 06/11/2023

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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-chemotherapy-after-surgery-for-breast-cancer

Contact information

Prof David Cameron
Scientific

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

Study information

Study design	Randomized 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	Trial of accelerated adjuvant chemotherapy with capecitabine in early breast cancer
Study 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
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

Eligibility

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 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 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

The Institute of Cancer Research (UK)
Research organisation

The Institute of Cancer Research
123 Brompton Road
London
SW7 3RP
United Kingdom

"ROR"	https://ror.org/043jzw605

Funders

Funder type

Industry

Cancer Research UK (CRUK) (UK) (ref: C1491/A4858)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Hoffman La-Roche (UK)
Private sector organisation / For-profit companies (industry)

Alternative name(s): Hoffman-La Roche, F. Hoffmann-La Roche Ltd.
Location: Switzerland

Amgen Ltd (UK)

No information available

Pfizer UK
Private sector organisation / For-profit companies (industry)

Alternative name(s): Pfizer Ltd, Pfizer Limited
Location: United Kingdom

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	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

Editorial Notes

06/11/2023: Publication reference added.
25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
13/09/2019: The following changes have been made:
1. The trial website has been removed as it was no longer active.
2. The sponsor contact details have been amended.
12/06/2017: Publication reference added.
19/11/2008: The overall trial end date was changed from 15/10/2008 to 05/12/2008.