Trial of accelerated adjuvant chemotherapy with capecitabine in early breast cancer
| ISRCTN | ISRCTN68068041 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68068041 |
| ClinicalTrials.gov (NCT) | NCT00301925 |
| Clinical Trials Information System (CTIS) | 2004-000066-13 |
| Protocol serial number | N/A |
| Sponsor | The Institute of Cancer Research (UK) |
| Funders | Cancer Research UK (CRUK) (UK) (ref: C1491/A4858), Hoffman La-Roche (UK), Amgen Ltd (UK), Pfizer UK |
- 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 of protocol
Contact information
Prof David Cameron
Scientific
Scientific
Edinburgh Research Centre
Western General Hospital
Crewe Road South
Edinburgh
EH4 2XR
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Trial of accelerated adjuvant chemotherapy with capecitabine in early breast cancer |
| Study acronym | TACT2 |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Capecitabine, cyclophosphamide, epirubicin hydrochloride, fluorouracil, methotrexate, pegfilgrastim |
| Primary outcome measure(s) |
Disease-free survival (DFS) |
| Key secondary outcome measure(s) |
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. |
| Completion date | 01/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 4400 |
| Total final enrolment | 4391 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2005 |
| Date of final enrolment | 05/12/2008 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Western General Hospital
Edinburgh
EH4 2XR
United Kingdom
EH4 2XR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| 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 | |
| Results article | 02/11/2023 | 06/11/2023 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 26/10/2022 | No | Yes |
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.
