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Combination Chemotherapy in Treating Patients With Early Stage Breast Cancer That Has Been Removed By Surgery (TACT2)

Primary Purpose

Breast Cancer

Status
Active
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
pegfilgrastim
capecitabine
cyclophosphamide
epirubicin hydrochloride
fluorouracil
methotrexate
adjuvant therapy
Sponsored by
Institute of Cancer Research, United Kingdom
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, male breast cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histological diagnosis of invasive breast carcinoma Cytological proof of malignancy alone is not sufficient Early stage disease (T0-3, N0-2, M0) without clinical suspicion or evidence of distant metastases on routine staging No locally advanced breast cancer (T4 and/or N3 disease) Completely resected disease by breast-conserving surgery with axillary node clearance or modified radical mastectomy within the past 4-8 weeks Negative surgical margins required, unless either of the following are true: Deep surgical margins after full thickness resection Noninvasive cancer at surgical margins for which a mastectomy is planned after completion of study chemotherapy No contraindication for or refusal of postoperative radiotherapy in patients who underwent prior breast-conserving surgery Definite indication for adjuvant chemotherapy No prior or current invasive breast cancer or bilateral breast cancer Prior surgically-treated ductal carcinoma in situ or lobular carcinoma in situ allowed Hormone receptor status: Estrogen receptor- and/or progesterone receptor-positive or -negative tumor PATIENT CHARACTERISTICS: Sex: male or female Menopausal status: premenopausal or postmenopausal No previous malignancy except basal cell carcinoma, carcinoma in situ of the cervix, or any cancer from which the patient has been disease-free for 10 years and for which treatment consisted solely of resection ECOG status 0 or 1 Hemoglobin > 9 g/dL WBC > 3,000/mm³ Platelet count > 10,000/mm³ Bilirubin normal (unless due to known Gilbert's disease) AST and ALT ≤ 1.5 times upper limit of normal (ULN) Albumin normal Creatinine ≤ 1.5 times ULN Creatinine clearance > 50 mL/min No active, uncontrolled infection Not pregnant or nursing Fertile patients must use effective contraception No concurrent medical, psychiatric, or geographic problems that might prevent completion of treatment or follow-up Available for a minimum of 5 years' follow-up No known serious viral infection such as active hepatitis B, hepatitis C, or HIV No significant cardiac disease, such as impaired left ventricular function or active angina requiring regular anti-anginal medication and/or resulting in restricted physical activity No history of significant renal impairment or disease PRIOR CONCURRENT THERAPY: No simultaneous participation in the active intervention phase of another treatment trial Not being approached or recruited for another trial within 2 months of study entry No previous chemotherapy, hormonal therapy or radiotherapy for the treatment of pre-invasive or invasive cancer except for either of the following: Previous radiotherapy for basal cell carcinoma Previous preoperative endocrine therapy, provided there was no evidence of progression during this therapy, it lasted for less than 6 weeks in duration, and it was stopped at least one month prior to trial entry Concurrent luteinizing hormone-releasing hormone analog therapy allowed for premenopausal patients More than 4 weeks since prior hormone replacement therapy (HRT) or pre-operative endocrine therapy No prior breast conserving surgery if there is a contradiction for or refusal of postoperative radiotherapy

Sites / Locations

  • William Harvey Hospital
  • Wansbeck General Hospital
  • Tameside General Hospital
  • North Devon District Hospital
  • Furness General Hospital
  • Basildon University Hospital
  • Basingstoke and North Hampshire NHS Foundation Trust
  • Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
  • City Hospital - Birmingham
  • Birmingham Heartlands Hospital
  • Royal Blackburn Hospital
  • Blackpool Victoria Hospital
  • Royal Bolton Hospital
  • Bradford Royal Infirmary
  • Sussex Cancer Centre at Royal Sussex County Hospital
  • Bristol Haematology and Oncology Centre
  • Broomfield Hospital
  • Burnley General Hospital
  • Queen's Hospital
  • West Suffolk Hospital
  • Addenbrooke's Hospital
  • Kent and Canterbury Hospital
  • Cheltenham General Hospital
  • Halton Hospital
  • Chesterfield Royal Hospital
  • Saint Richards Hospital
  • Essex County Hospital
  • Walsgrave Hospital
  • Darent Valley Hospital
  • Derbyshire Royal Infirmary
  • Dewsbury and District Hospital
  • Doncaster Royal Infirmary
  • Russells Hall Hospital
  • University Hospital of North Durham
  • Eastbourne District General Hospital
  • Royal Devon and Exeter Hospital
  • Queen Elizabeth Hospital
  • Gloucestershire Royal Hospital
  • Diana Princess of Wales Hospital
  • St. Luke's Cancer Centre at Royal Surrey County Hospital
  • UCL Cancer Institute
  • Hereford Hospitals NHS Trust
  • Wycombe General Hospital
  • Huddersfield Royal Infirmary
  • Princess Royal Hospital at Hull and East Yorkshire NHS Trust
  • King George Hospital
  • Ipswich Hospital
  • West Middlesex University Hospital
  • Airedale General Hospital
  • Kettering General Hosptial
  • Kidderminster Hospital
  • Queen Elizabeth Hospital
  • Royal Albert Edward Infirmary
  • Royal Lancaster Infirmary
  • Cookridge Hospital
  • National Cancer Research Network
  • Cancer Research UK Clinical Centre at St. James's University Hospital
  • Leeds Cancer Centre at St. James's University Hospital
  • Royal Liverpool University Hospital
  • Aintree University Hospital
  • Barts and the London School of Medicine
  • Whittington Hospital
  • University College Hospital
  • Guy's Hospital
  • King's College Hospital
  • St. George's Hospital
  • St. Mary's Hospital
  • Charing Cross Hospital
  • Macclesfield District General Hospital
  • Maidstone Hospital
  • Christie Hospital
  • Withington Hospital
  • North Manchester General Hospital - Penine Actute Hospitals Trust
  • Queen Elizabeth The Queen Mother Hospital
  • Clatterbridge Centre for Oncology
  • James Cook University Hospital
  • Northern Centre for Cancer Treatment at Newcastle General Hospital
  • St. Mary's Hospital
  • James Paget Hospital
  • North Tyneside Hospital
  • Friarage Hospital
  • Northampton General Hospital NHS Trust
  • Norfolk and Norwich University Hospital
  • King's Mills Hospital
  • Nottingham City Hospital NHS Trust
  • George Eliot Hospital
  • Royal Oldham Hospital
  • Radcliffe Infirmary NHS Trust
  • Churchill Hospital
  • Peterborough Hospitals Trust
  • Pontefract General Infirmary
  • Whiston Hospital
  • Royal Preston Hospital
  • Alexandra Healthcare NHS
  • Oldchurch Hospital
  • Conquest Hospital
  • Salisbury District Hospital
  • Scunthorpe General Hospital
  • Cancer Research Centre at Weston Park Hospital
  • Royal Shrewsbury Hospital
  • Solihull Hospital
  • Southampton General Hospital
  • Southport and Formby District General Hospital
  • Stepping Hill Hospital
  • University Hospital of North Staffordshire
  • Sunderland Royal Hospital
  • Great Western Hospital
  • Taunton and Somerset Hospital
  • Torbay Hospital
  • Royal Cornwall Hospital
  • Walsall Manor Hospital
  • Warrington Hospital NHS Trust
  • South Warwickshire Hospital
  • Sandwell General Hospital
  • Southend University Hospital NHS Foundation Trust
  • Weston General Hospital
  • Royal Hampshire County Hospital
  • New Cross Hospital
  • Worcester Royal Hospital
  • Yeovil District Hospital
  • Belfast City Hospital Trust Incorporating Belvoir Park Hospital
  • Centre for Cancer Research and Cell Biology at Queen's University Belfast
  • Altnagelvin Area Hospital
  • Aberdeen Royal Infirmary
  • Ayr Hospital
  • Dumfries & Galloway Royal Infirmary
  • Ninewells Hospital
  • Queen Margaret Hospital - Dunfermline
  • Hairmyres Hospital
  • Edinburgh Cancer Centre at Western General Hospital
  • Dr Gray's Hospital
  • Falkirk & District Royal Infirmary
  • Beatson West of Scotland Cancer Centre
  • Royal Infirmary - Castle
  • Inverclyde Royal Hospital
  • Raigmore Hospital
  • Crosshouse Hospital
  • St. John's Hospital
  • Scarborough General Hospital
  • Pinderfields General Hospital
  • Wishaw General Hospital
  • Bronglais District General Hospital
  • Ysbyty Gwynedd
  • Princess of Wales Hospital
  • Velindre Cancer Center at Velindre Hospital
  • Withybush General Hospital
  • Royal Glamorgan Hospital
  • Prince Charles Hospital
  • Royal Gwent Hospital
  • Glan Clwyd Hospital
  • Wrexham Maelor Hospital
  • Barnet General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Epi-CMF

Accelerated Epi-CMF

Epi-Capecitabine

Accelerated Epi-Capecitabine

Arm Description

Outcomes

Primary Outcome Measures

Disease-free survival (DFS) at 5 years

Secondary Outcome Measures

Overall survival at 5 years
Distant DFS at 5 years
Tolerability (including serious adverse events, dose-intensity, and toxicity)
Detailed toxicity
Quality of life

Full Information

First Posted
March 9, 2006
Last Updated
August 7, 2018
Sponsor
Institute of Cancer Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT00301925
Brief Title
Combination Chemotherapy in Treating Patients With Early Stage Breast Cancer That Has Been Removed By Surgery
Acronym
TACT2
Official Title
Trial of Accelerated Adjuvant Chemotherapy With Capecitabine in Early Breast Cancer (TACT2)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 16, 2005 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Cancer Research, United Kingdom

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating early stage breast cancer that has been removed by surgery. PURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens to compare how well they work in treating patients with early stage breast cancer that has been removed by surgery.
Detailed Description
OBJECTIVES: Primary Compare the disease-free survival (DFS) of patients with completely resected early stage breast cancer receiving 1 of 2 different schedules of adjuvant chemotherapy comprising epirubicin, cyclophosphamide, methotrexate, and fluorouracil versus 1 of 2 different schedules of adjuvant chemotherapy comprising epirubicin and capecitabine. Secondary Compare overall survival (OS) and distant disease-free survival (DFS). Compare the tolerability (including serious adverse events [SAE], dose-intensity, and toxicity) of these regimens. Determine the detailed toxicity of these regimens. Determine the quality of life of a subset of these patients. OUTLINE: This is a multi-center, randomized study. Patients are stratified according to participating center, nodal status (N0 vs N1-3 vs N≥ 4), age (≤ 50 years vs > 50 years), and estrogen receptor (ER) status (negative vs positive). Patients are randomized to 1 of 4 treatment arms. Arm I: Patients receive epirubicin on day 1. Treatment repeats every 3 weeks for 4 courses. Patients then receive cyclophosphamide orally once daily on days 1-14 or IV on days 1 and 8 and methotrexate and fluorouracil on days 1 and 8. Treatment repeats every 28 days for 4 courses. Arm II: Patients receive epirubicin on day 1 and pegfilgrastim on day 2. Treatment repeats every 2 weeks for 4 courses. Patients then receive cyclophosphamide, methotrexate and fluorouracil as in arm I. Arm III: Patients receive epirubicin as in arm I. Patients then receive oral capecitabine twice daily on days 1-14. Treatment with capecitabine repeats every 3 weeks for 4 courses. Arm IV: Patients receive epirubicin and pegfilgrastim as in arm II. Patients then receive capecitabine as in arm III. In all arms, treatment continues in the absence of unacceptable toxicity. Beginning 3-6 months later, all patients may undergo radiotherapy at the discretion of the principal investigator. Patients with ER- and/or progesterone receptor-positive disease then receive tamoxifen citrate or an aromatase inhibitor for up to 5 years. Quality of life is assessed in a cohort of 1,000 patients in week 6, week 8 or 12, and week 20 or 24 during treatment and then at 12 and 24 months after randomization. After completion of study therapy, patients are followed every 6 months for 2 years and then annually for at least 10 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK. PROJECTED ACCRUAL: A total of 4,400 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, male breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Allocation
Randomized
Enrollment
4400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epi-CMF
Arm Type
Active Comparator
Arm Title
Accelerated Epi-CMF
Arm Type
Experimental
Arm Title
Epi-Capecitabine
Arm Type
Experimental
Arm Title
Accelerated Epi-Capecitabine
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
pegfilgrastim
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
epirubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Disease-free survival (DFS) at 5 years
Secondary Outcome Measure Information:
Title
Overall survival at 5 years
Title
Distant DFS at 5 years
Title
Tolerability (including serious adverse events, dose-intensity, and toxicity)
Title
Detailed toxicity
Title
Quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histological diagnosis of invasive breast carcinoma Cytological proof of malignancy alone is not sufficient Early stage disease (T0-3, N0-2, M0) without clinical suspicion or evidence of distant metastases on routine staging No locally advanced breast cancer (T4 and/or N3 disease) Completely resected disease by breast-conserving surgery with axillary node clearance or modified radical mastectomy within the past 4-8 weeks Negative surgical margins required, unless either of the following are true: Deep surgical margins after full thickness resection Noninvasive cancer at surgical margins for which a mastectomy is planned after completion of study chemotherapy No contraindication for or refusal of postoperative radiotherapy in patients who underwent prior breast-conserving surgery Definite indication for adjuvant chemotherapy No prior or current invasive breast cancer or bilateral breast cancer Prior surgically-treated ductal carcinoma in situ or lobular carcinoma in situ allowed Hormone receptor status: Estrogen receptor- and/or progesterone receptor-positive or -negative tumor PATIENT CHARACTERISTICS: Sex: male or female Menopausal status: premenopausal or postmenopausal No previous malignancy except basal cell carcinoma, carcinoma in situ of the cervix, or any cancer from which the patient has been disease-free for 10 years and for which treatment consisted solely of resection ECOG status 0 or 1 Hemoglobin > 9 g/dL WBC > 3,000/mm³ Platelet count > 10,000/mm³ Bilirubin normal (unless due to known Gilbert's disease) AST and ALT ≤ 1.5 times upper limit of normal (ULN) Albumin normal Creatinine ≤ 1.5 times ULN Creatinine clearance > 50 mL/min No active, uncontrolled infection Not pregnant or nursing Fertile patients must use effective contraception No concurrent medical, psychiatric, or geographic problems that might prevent completion of treatment or follow-up Available for a minimum of 5 years' follow-up No known serious viral infection such as active hepatitis B, hepatitis C, or HIV No significant cardiac disease, such as impaired left ventricular function or active angina requiring regular anti-anginal medication and/or resulting in restricted physical activity No history of significant renal impairment or disease PRIOR CONCURRENT THERAPY: No simultaneous participation in the active intervention phase of another treatment trial Not being approached or recruited for another trial within 2 months of study entry No previous chemotherapy, hormonal therapy or radiotherapy for the treatment of pre-invasive or invasive cancer except for either of the following: Previous radiotherapy for basal cell carcinoma Previous preoperative endocrine therapy, provided there was no evidence of progression during this therapy, it lasted for less than 6 weeks in duration, and it was stopped at least one month prior to trial entry Concurrent luteinizing hormone-releasing hormone analog therapy allowed for premenopausal patients More than 4 weeks since prior hormone replacement therapy (HRT) or pre-operative endocrine therapy No prior breast conserving surgery if there is a contradiction for or refusal of postoperative radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Cameron, MD
Organizational Affiliation
National Cancer Research Network
Official's Role
Study Chair
Facility Information:
Facility Name
William Harvey Hospital
City
Ashford-Kent
State/Province
England
ZIP/Postal Code
TN24 0LZ
Country
United Kingdom
Facility Name
Wansbeck General Hospital
City
Ashington
State/Province
England
ZIP/Postal Code
NE63 9JJ
Country
United Kingdom
Facility Name
Tameside General Hospital
City
Ashton-Under-Lyne
State/Province
England
ZIP/Postal Code
OL6 9RW
Country
United Kingdom
Facility Name
North Devon District Hospital
City
Barnstaple
State/Province
England
ZIP/Postal Code
EX31 4JB
Country
United Kingdom
Facility Name
Furness General Hospital
City
Barrow in Furness
State/Province
England
ZIP/Postal Code
LA14 4LF
Country
United Kingdom
Facility Name
Basildon University Hospital
City
Basildon
State/Province
England
ZIP/Postal Code
SS16 5NL
Country
United Kingdom
Facility Name
Basingstoke and North Hampshire NHS Foundation Trust
City
Basingstoke
State/Province
England
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
City Hospital - Birmingham
City
Birmingham
State/Province
England
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Royal Blackburn Hospital
City
Blackburn
State/Province
England
ZIP/Postal Code
BB2 3HH
Country
United Kingdom
Facility Name
Blackpool Victoria Hospital
City
Blackpool
State/Province
England
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
Royal Bolton Hospital
City
Bolton, Lancashire
State/Province
England
ZIP/Postal Code
BL4 0JR
Country
United Kingdom
Facility Name
Bradford Royal Infirmary
City
Bradford
State/Province
England
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Sussex Cancer Centre at Royal Sussex County Hospital
City
Brighton
State/Province
England
ZIP/Postal Code
BN2 5BF
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Broomfield Hospital
City
Broomefield
State/Province
England
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Facility Name
Burnley General Hospital
City
Burnley
State/Province
England
ZIP/Postal Code
BB10 2PQ
Country
United Kingdom
Facility Name
Queen's Hospital
City
Burton-upon-Trent
State/Province
England
ZIP/Postal Code
DE13 0RB
Country
United Kingdom
Facility Name
West Suffolk Hospital
City
Bury St. Edmunds
State/Province
England
ZIP/Postal Code
IP33 2QZ
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Kent and Canterbury Hospital
City
Canterbury
State/Province
England
ZIP/Postal Code
CT2 3NG
Country
United Kingdom
Facility Name
Cheltenham General Hospital
City
Cheltenham
State/Province
England
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
Halton Hospital
City
Cheshire
State/Province
England
ZIP/Postal Code
WA7 2DA
Country
United Kingdom
Facility Name
Chesterfield Royal Hospital
City
Chesterfield
State/Province
England
ZIP/Postal Code
S44 5BL
Country
United Kingdom
Facility Name
Saint Richards Hospital
City
Chichester
State/Province
England
ZIP/Postal Code
P019 4SE
Country
United Kingdom
Facility Name
Essex County Hospital
City
Colchester
State/Province
England
ZIP/Postal Code
C03 3NB
Country
United Kingdom
Facility Name
Walsgrave Hospital
City
Coventry
State/Province
England
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Darent Valley Hospital
City
Dartford Kent
State/Province
England
ZIP/Postal Code
DA2 8DA
Country
United Kingdom
Facility Name
Derbyshire Royal Infirmary
City
Derby
State/Province
England
ZIP/Postal Code
DE1 2QY
Country
United Kingdom
Facility Name
Dewsbury and District Hospital
City
Dewsbury
State/Province
England
ZIP/Postal Code
WF13 4HS
Country
United Kingdom
Facility Name
Doncaster Royal Infirmary
City
Doncaster
State/Province
England
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
Facility Name
Russells Hall Hospital
City
Dudley
State/Province
England
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
University Hospital of North Durham
City
Durham
State/Province
England
ZIP/Postal Code
DH1 5TW
Country
United Kingdom
Facility Name
Eastbourne District General Hospital
City
Eastbourne
State/Province
England
ZIP/Postal Code
BN21 2UD
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
State/Province
England
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Gateshead
State/Province
England
ZIP/Postal Code
NE9 6SX
Country
United Kingdom
Facility Name
Gloucestershire Royal Hospital
City
Gloucester
State/Province
England
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
Diana Princess of Wales Hospital
City
Grimsby
State/Province
England
ZIP/Postal Code
DN33 2BA
Country
United Kingdom
Facility Name
St. Luke's Cancer Centre at Royal Surrey County Hospital
City
Guildford
State/Province
England
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
UCL Cancer Institute
City
Hampstead, London
State/Province
England
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Hereford Hospitals NHS Trust
City
Hereford
State/Province
England
ZIP/Postal Code
HR1 2ER
Country
United Kingdom
Facility Name
Wycombe General Hospital
City
High Wycombe
State/Province
England
Country
United Kingdom
Facility Name
Huddersfield Royal Infirmary
City
Huddersfield, West Yorks
State/Province
England
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Facility Name
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
City
Hull
State/Province
England
ZIP/Postal Code
HU8 9HE
Country
United Kingdom
Facility Name
King George Hospital
City
Ilford, Essex
State/Province
England
ZIP/Postal Code
IG3 8YB
Country
United Kingdom
Facility Name
Ipswich Hospital
City
Ipswich
State/Province
England
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
West Middlesex University Hospital
City
Isleworth
State/Province
England
ZIP/Postal Code
TW7 6AF
Country
United Kingdom
Facility Name
Airedale General Hospital
City
Keighley
State/Province
England
ZIP/Postal Code
BD20 6TD
Country
United Kingdom
Facility Name
Kettering General Hosptial
City
Kettering, Northants
State/Province
England
ZIP/Postal Code
NNI6 8UZ
Country
United Kingdom
Facility Name
Kidderminster Hospital
City
Kidderminster Worcestershire
State/Province
England
ZIP/Postal Code
DY11 6RJ
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
King's Lynn
State/Province
England
ZIP/Postal Code
PE30 4ET
Country
United Kingdom
Facility Name
Royal Albert Edward Infirmary
City
Lancanshire
State/Province
England
ZIP/Postal Code
WN1 2NN
Country
United Kingdom
Facility Name
Royal Lancaster Infirmary
City
Lancaster
State/Province
England
ZIP/Postal Code
LA1 4RP
Country
United Kingdom
Facility Name
Cookridge Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS16 6QB
Country
United Kingdom
Facility Name
National Cancer Research Network
City
Leeds
State/Province
England
ZIP/Postal Code
LS2 9LN
Country
United Kingdom
Facility Name
Cancer Research UK Clinical Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Aintree University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Barts and the London School of Medicine
City
London
State/Province
England
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
Whittington Hospital
City
London
State/Province
England
ZIP/Postal Code
N19 5NF
Country
United Kingdom
Facility Name
University College Hospital
City
London
State/Province
England
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
State/Province
England
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
King's College Hospital
City
London
State/Province
England
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
St. George's Hospital
City
London
State/Province
England
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
St. Mary's Hospital
City
London
State/Province
England
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Macclesfield District General Hospital
City
Macclesfield
State/Province
England
ZIP/Postal Code
SK10 3BL
Country
United Kingdom
Facility Name
Maidstone Hospital
City
Maidstone
State/Province
England
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Withington Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 8LR
Country
United Kingdom
Facility Name
North Manchester General Hospital - Penine Actute Hospitals Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M8 6RB
Country
United Kingdom
Facility Name
Queen Elizabeth The Queen Mother Hospital
City
Margate
State/Province
England
ZIP/Postal Code
CT9 4AN
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesbrough
State/Province
England
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Northern Centre for Cancer Treatment at Newcastle General Hospital
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
St. Mary's Hospital
City
Newport
State/Province
England
ZIP/Postal Code
PO30 5TG
Country
United Kingdom
Facility Name
James Paget Hospital
City
Norfolk
State/Province
England
ZIP/Postal Code
NR31 6LA
Country
United Kingdom
Facility Name
North Tyneside Hospital
City
North Shields
State/Province
England
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Facility Name
Friarage Hospital
City
North Yorkshire
State/Province
England
ZIP/Postal Code
DL6 1JG
Country
United Kingdom
Facility Name
Northampton General Hospital NHS Trust
City
Northampton
State/Province
England
ZIP/Postal Code
NN6 8BJ
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
State/Province
England
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
King's Mills Hospital
City
Nottinghamshire
State/Province
England
ZIP/Postal Code
NG17 4JL
Country
United Kingdom
Facility Name
Nottingham City Hospital NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
George Eliot Hospital
City
Nuneaton
State/Province
England
ZIP/Postal Code
CV10 7DJ
Country
United Kingdom
Facility Name
Royal Oldham Hospital
City
Oldham
State/Province
England
ZIP/Postal Code
OL1 2JH
Country
United Kingdom
Facility Name
Radcliffe Infirmary NHS Trust
City
Oxford
State/Province
England
ZIP/Postal Code
OX2 6HE
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Peterborough Hospitals Trust
City
Peterborough
State/Province
England
ZIP/Postal Code
PE3 6DA
Country
United Kingdom
Facility Name
Pontefract General Infirmary
City
Pontefract West Yorkshire
State/Province
England
ZIP/Postal Code
WF8 1PL
Country
United Kingdom
Facility Name
Whiston Hospital
City
Prescot Merseyside
State/Province
England
ZIP/Postal Code
L35 5DR
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
State/Province
England
ZIP/Postal Code
PR2 4QF
Country
United Kingdom
Facility Name
Alexandra Healthcare NHS
City
Redditch, Worcestershire
State/Province
England
ZIP/Postal Code
B98 7UB
Country
United Kingdom
Facility Name
Oldchurch Hospital
City
Romford
State/Province
England
ZIP/Postal Code
RM7 OBE
Country
United Kingdom
Facility Name
Conquest Hospital
City
Saint Leonards-on-Sea
State/Province
England
ZIP/Postal Code
TN37 7RD
Country
United Kingdom
Facility Name
Salisbury District Hospital
City
Salisbury
State/Province
England
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
Facility Name
Scunthorpe General Hospital
City
Scunthorpe
State/Province
England
ZIP/Postal Code
DN15 7BH
Country
United Kingdom
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
Royal Shrewsbury Hospital
City
Shrewsbury
State/Province
England
ZIP/Postal Code
SY3 8XQ
Country
United Kingdom
Facility Name
Solihull Hospital
City
Solihull
State/Province
England
ZIP/Postal Code
B91 2JL
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Southport and Formby District General Hospital
City
Southport
State/Province
England
ZIP/Postal Code
PR8 6PN
Country
United Kingdom
Facility Name
Stepping Hill Hospital
City
Stockport
State/Province
England
ZIP/Postal Code
SK2 7JE
Country
United Kingdom
Facility Name
University Hospital of North Staffordshire
City
Stoke-On-Trent
State/Province
England
ZIP/Postal Code
ST4 7LN
Country
United Kingdom
Facility Name
Sunderland Royal Hospital
City
Sunderland
State/Province
England
ZIP/Postal Code
SR4 7TP
Country
United Kingdom
Facility Name
Great Western Hospital
City
Swindon
State/Province
England
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
Facility Name
Taunton and Somerset Hospital
City
Taunton
State/Province
England
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
Torbay Hospital
City
Torquay
State/Province
England
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro, Cornwall
State/Province
England
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Walsall Manor Hospital
City
Walsall
State/Province
England
ZIP/Postal Code
WS2 9PS
Country
United Kingdom
Facility Name
Warrington Hospital NHS Trust
City
Warrington
State/Province
England
ZIP/Postal Code
WA5 1QG
Country
United Kingdom
Facility Name
South Warwickshire Hospital
City
Warwick, Warwickshire
State/Province
England
ZIP/Postal Code
CV34 5BJ
Country
United Kingdom
Facility Name
Sandwell General Hospital
City
West Bromwich
State/Province
England
ZIP/Postal Code
B71 4HJ
Country
United Kingdom
Facility Name
Southend University Hospital NHS Foundation Trust
City
Westcliff-On-Sea
State/Province
England
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Facility Name
Weston General Hospital
City
Weston-super-Mare
State/Province
England
ZIP/Postal Code
BS23 4TQ
Country
United Kingdom
Facility Name
Royal Hampshire County Hospital
City
Winchester
State/Province
England
ZIP/Postal Code
SO22 5DG
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
State/Province
England
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Worcester Royal Hospital
City
Worcester
State/Province
England
ZIP/Postal Code
WR5 1DD
Country
United Kingdom
Facility Name
Yeovil District Hospital
City
Yeovil - Somerset
State/Province
England
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
Facility Name
Belfast City Hospital Trust Incorporating Belvoir Park Hospital
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT8 8JR
Country
United Kingdom
Facility Name
Centre for Cancer Research and Cell Biology at Queen's University Belfast
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Altnagelvin Area Hospital
City
Londonderry
State/Province
Northern Ireland
ZIP/Postal Code
BT47 1SB
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Ayr Hospital
City
Ayr
State/Province
Scotland
ZIP/Postal Code
KA6 6DX
Country
United Kingdom
Facility Name
Dumfries & Galloway Royal Infirmary
City
Dumfries
State/Province
Scotland
ZIP/Postal Code
DG1 4AP
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Queen Margaret Hospital - Dunfermline
City
Dunfermline
State/Province
Scotland
ZIP/Postal Code
KY12 0SU
Country
United Kingdom
Facility Name
Hairmyres Hospital
City
East Kilbride
State/Province
Scotland
ZIP/Postal Code
G75 8RG
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre at Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Dr Gray's Hospital
City
Elgin
State/Province
Scotland
ZIP/Postal Code
IV30 1SN
Country
United Kingdom
Facility Name
Falkirk & District Royal Infirmary
City
Falkirk
State/Province
Scotland
ZIP/Postal Code
FK1 5QE
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Royal Infirmary - Castle
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Inverclyde Royal Hospital
City
Greenock
State/Province
Scotland
ZIP/Postal Code
PA16 0XN
Country
United Kingdom
Facility Name
Raigmore Hospital
City
Inverness
State/Province
Scotland
ZIP/Postal Code
1V2 3UJ
Country
United Kingdom
Facility Name
Crosshouse Hospital
City
Kilmarnock
State/Province
Scotland
ZIP/Postal Code
KA2 OBE
Country
United Kingdom
Facility Name
St. John's Hospital
City
Livingston
State/Province
Scotland
ZIP/Postal Code
EH54 6PP
Country
United Kingdom
Facility Name
Scarborough General Hospital
City
Scarborough
State/Province
Scotland
ZIP/Postal Code
YO12 6QL
Country
United Kingdom
Facility Name
Pinderfields General Hospital
City
Wakefield
State/Province
Scotland
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
Facility Name
Wishaw General Hospital
City
Wishaw
State/Province
Scotland
ZIP/Postal Code
ML2 0DP
Country
United Kingdom
Facility Name
Bronglais District General Hospital
City
Aberystwyth
State/Province
Wales
ZIP/Postal Code
SY23 1ER
Country
United Kingdom
Facility Name
Ysbyty Gwynedd
City
Bangor
State/Province
Wales
ZIP/Postal Code
LL57 2PW
Country
United Kingdom
Facility Name
Princess of Wales Hospital
City
Bridgend
State/Province
Wales
ZIP/Postal Code
CF31 1JP
Country
United Kingdom
Facility Name
Velindre Cancer Center at Velindre Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Withybush General Hospital
City
Haverfordwest
State/Province
Wales
ZIP/Postal Code
SA61 2PZ
Country
United Kingdom
Facility Name
Royal Glamorgan Hospital
City
Lhantrisant
State/Province
Wales
ZIP/Postal Code
CF72 8XR
Country
United Kingdom
Facility Name
Prince Charles Hospital
City
Mid Glamorgan
State/Province
Wales
ZIP/Postal Code
CF47 9DT
Country
United Kingdom
Facility Name
Royal Gwent Hospital
City
Newport Gwent
State/Province
Wales
ZIP/Postal Code
NP9 2UB
Country
United Kingdom
Facility Name
Glan Clwyd Hospital
City
Rhyl, Denbighshire
State/Province
Wales
ZIP/Postal Code
LL 18 5UJ
Country
United Kingdom
Facility Name
Wrexham Maelor Hospital
City
Wrexham
State/Province
Wales
ZIP/Postal Code
LL13 7NT
Country
United Kingdom
Facility Name
Barnet General Hospital
City
Barnet, Hertfordshire
ZIP/Postal Code
EN5 3DJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34037241
Citation
Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
Results Reference
derived
PubMed Identifier
28600210
Citation
Cameron D, Morden JP, Canney P, Velikova G, Coleman R, Bartlett J, Agrawal R, Banerji J, Bertelli G, Bloomfield D, Brunt AM, Earl H, Ellis P, Gaunt C, Gillman A, Hearfield N, Laing R, Murray N, Couper N, Stein RC, Verrill M, Wardley A, Barrett-Lee P, Bliss JM; TACT2 Investigators. Accelerated versus standard epirubicin followed by cyclophosphamide, methotrexate, and fluorouracil or capecitabine as adjuvant therapy for breast cancer in the randomised UK TACT2 trial (CRUK/05/19): a multicentre, phase 3, open-label, randomised, controlled trial. Lancet Oncol. 2017 Jul;18(7):929-945. doi: 10.1016/S1470-2045(17)30404-7. Epub 2017 Jun 7.
Results Reference
derived

Learn more about this trial

Combination Chemotherapy in Treating Patients With Early Stage Breast Cancer That Has Been Removed By Surgery

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