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Combination Chemotherapy in Treating Women With Breast Cancer Who Have Undergone Surgery

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
cyclophosphamide
epirubicin hydrochloride
gemcitabine hydrochloride
paclitaxel
adjuvant therapy
Sponsored by
Cancer Research Campaign Clinical Trials Centre
About
Eligibility
Locations
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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed invasive breast cancer Early stage disease Completely resected disease No more than 8 weeks since prior resection Any nodal status Indication for adjuvant chemotherapy No metastatic disease Hormone receptor status: Estrogen receptor negative or weakly positive OR Estrogen receptor positive AND progesterone receptor negative or weakly positive PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin normal AST and ALT no greater than 1.5 times normal Renal: Creatinine no greater than 1.5 times normal Other: Fit to receive study chemotherapy No active uncontrolled infection No other malignancy within the past 10 years except basal cell carcinoma or carcinoma in situ of the cervix No other concurrent medical or psychiatric problems that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

Sites / Locations

  • Queen Elizabeth Hospital at University of Birmingham
  • Cancer Research UK Clinical Trials Unit - Birmingham
  • City Hospital - Birmingham
  • Birmingham Heartlands and Solihull NHS Trust -Teaching
  • Queen's Hospital, Burton
  • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
  • Broomfield Hospital
  • Essex County Hospital
  • Walsgrave Hospital
  • Dorset County Hospital
  • Royal Devon and Exeter Hospital
  • Princess Royal Hospital
  • Hinchingbrooke Hospital
  • King George Hospital
  • Crosshouse Hospital
  • Cookridge Hospital at Leeds Teaching Hospital NHS Trust
  • Leeds Cancer Centre at St. James's University Hospital
  • St. George's Hospital
  • Christie Hospital N.H.S. Trust
  • Clatterbridge Centre for Oncology NHS Trust
  • James Cook University Hospital
  • Northern Centre for Cancer Treatment at Newcastle General Hospital
  • Northampton General Hospital NHS Trust
  • Nottingham City Hospital NHS Trust
  • Peterborough Hospitals Trust
  • Derriford Hospital
  • Oldchurch Hospital
  • Thornbury Hospital
  • Cancer Research Centre at Weston Park Hospital
  • Royal Shrewsbury Hospital
  • West Suffolk Hospital
  • Torbay Hospital
  • Walsall Manor Hospital
  • Sandwell General Hospital
  • Good Hope Hospital Trust
  • Worcester Royal Hospital
  • Western General Hospital
  • Beatson Oncology Centre
  • Royal Infirmary - Castle
  • Velindre Cancer Center at Velinde Hospital
  • Hairmyres Hospital
  • Hull Royal Infirmary
  • Queen Elizabeth Hospital
  • Glan Clywd District General Hospital
  • Singleton Hospital
  • Morriston Hospital NHS Trust

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2002
Last Updated
August 6, 2013
Sponsor
Cancer Research Campaign Clinical Trials Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00039546
Brief Title
Combination Chemotherapy in Treating Women With Breast Cancer Who Have Undergone Surgery
Official Title
'tAnGo', A Phase III Randomised Trial Of Gemcitabine In Paclitaxel-Containing, Epirubicin-Based, Adjuvant Chemotherapy For ER/PgR-Poor, Early Stage, Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2005
Overall Recruitment Status
Unknown status
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Cancer Research Campaign Clinical Trials Centre

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating women after surgery for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel, epirubicin, and cyclophosphamide with or without gemcitabine in treating women who have undergone surgery for breast cancer.
Detailed Description
OBJECTIVES: Compare the 5-year and 10-year disease-free survival and overall survival of women with completely resected early stage breast cancer treated with adjuvant paclitaxel, epirubicin, and cyclophosphamide with or without gemcitabine. Compare the toxicity, dose-intensity, and tolerability of these regimens in these patients. Compare the serious adverse events in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to nodal status (negative vs 1-3 vs 4 or more), age (50 and under vs over 50), estrogen receptor status (negative vs weakly positive vs positive), concurrent radiotherapy (no vs yes), HER2 status (3+ overexpression vs other vs not measured), and country. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive epirubicin IV, cyclophosphamide IV, and paclitaxel IV over 3 hours on day 1. Patients also receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive epirubicin, cyclophosphamide, and paclitaxel as in arm I. Patients are followed every 3 months for 6 months, every 6 months for 3 years, and then annually for 6 years. PROJECTED ACCRUAL: A total of 3,000 patients (1,500 per treatment arm) will be accrued for this study within 3-4 years.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
epirubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed invasive breast cancer Early stage disease Completely resected disease No more than 8 weeks since prior resection Any nodal status Indication for adjuvant chemotherapy No metastatic disease Hormone receptor status: Estrogen receptor negative or weakly positive OR Estrogen receptor positive AND progesterone receptor negative or weakly positive PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin normal AST and ALT no greater than 1.5 times normal Renal: Creatinine no greater than 1.5 times normal Other: Fit to receive study chemotherapy No active uncontrolled infection No other malignancy within the past 10 years except basal cell carcinoma or carcinoma in situ of the cervix No other concurrent medical or psychiatric problems that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Howard, PhD
Organizational Affiliation
Cancer Research Campaign Clinical Trials Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Queen Elizabeth Hospital at University of Birmingham
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Cancer Research UK Clinical Trials Unit - Birmingham
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TT
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 and Solihull NHS Trust -Teaching
City
Birmingham
State/Province
England
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Queen's Hospital, Burton
City
Burton-upon-Trent
State/Province
England
ZIP/Postal Code
DE14 3QH
Country
United Kingdom
Facility Name
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Broomfield Hospital
City
Chelmsford, Essex
State/Province
England
ZIP/Postal Code
CM1 5ET
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
Dorset County Hospital
City
Dorchester
State/Province
England
ZIP/Postal Code
DT1 2JY
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
Princess Royal Hospital
City
Hull
State/Province
England
ZIP/Postal Code
HU8 9HE
Country
United Kingdom
Facility Name
Hinchingbrooke Hospital
City
Huntingdon
State/Province
England
ZIP/Postal Code
PE18 6NT
Country
United Kingdom
Facility Name
King George Hospital
City
Ilford, Essex
State/Province
England
ZIP/Postal Code
IG3 8YB
Country
United Kingdom
Facility Name
Crosshouse Hospital
City
Kilmarnock
State/Province
England
ZIP/Postal Code
KA2 OBE
Country
United Kingdom
Facility Name
Cookridge Hospital at Leeds Teaching Hospital NHS Trust
City
Leeds
State/Province
England
ZIP/Postal Code
LS16 6QB
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
St. George's Hospital
City
London
State/Province
England
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Christie Hospital N.H.S. Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology NHS Trust
City
Merseyside
State/Province
England
ZIP/Postal Code
L63 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
Northampton General Hospital NHS Trust
City
Northampton
State/Province
England
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
Peterborough Hospitals Trust
City
Peterborough
State/Province
England
ZIP/Postal Code
PE3 6DA
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
State/Province
England
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Oldchurch Hospital
City
Romford
State/Province
England
ZIP/Postal Code
RM7 OBE
Country
United Kingdom
Facility Name
Thornbury Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 3BR
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
Country
United Kingdom
Facility Name
West Suffolk Hospital
City
Suffolk
State/Province
England
ZIP/Postal Code
IP33 2QZ
Country
United Kingdom
Facility Name
Torbay Hospital
City
Torquay Devon
State/Province
England
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Walsall Manor Hospital
City
Walsall
State/Province
England
ZIP/Postal Code
WS2 9PS
Country
United Kingdom
Facility Name
Sandwell General Hospital
City
West Bromwich
State/Province
England
ZIP/Postal Code
B71 4HJ
Country
United Kingdom
Facility Name
Good Hope Hospital Trust
City
West Midlands
State/Province
England
ZIP/Postal Code
B75 7RR
Country
United Kingdom
Facility Name
Worcester Royal Hospital
City
Worcester
State/Province
England
ZIP/Postal Code
WR5 1JG
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Beatson Oncology 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
Velindre Cancer Center at Velinde Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF4 7XL
Country
United Kingdom
Facility Name
Hairmyres Hospital
City
East Kilbride
ZIP/Postal Code
G75 8RG
Country
United Kingdom
Facility Name
Hull Royal Infirmary
City
Hull
ZIP/Postal Code
HU3 2KZ
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
King's Lynn
ZIP/Postal Code
PE30 4ET
Country
United Kingdom
Facility Name
Glan Clywd District General Hospital
City
Rhyl, Denbighshire
ZIP/Postal Code
LL 18 5UJ
Country
United Kingdom
Facility Name
Singleton Hospital
City
Swansea
ZIP/Postal Code
SA 2 8QA
Country
United Kingdom
Facility Name
Morriston Hospital NHS Trust
City
West Glamorgen
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28479233
Citation
Earl HM, Hiller L, Howard HC, Dunn JA, Young J, Bowden SJ, McDermaid M, Waterhouse AK, Wilson G, Agrawal R, O'Reilly S, Bowman A, Ritchie DM, Goodman A, Hickish T, McAdam K, Cameron D, Dodwell D, Rea DW, Caldas C, Provenzano E, Abraham JE, Canney P, Crown JP, Kennedy MJ, Coleman R, Leonard RC, Carmichael JA, Wardley AM, Poole CJ; tAnGo trial collaborators. Addition of gemcitabine to paclitaxel, epirubicin, and cyclophosphamide adjuvant chemotherapy for women with early-stage breast cancer (tAnGo): final 10-year follow-up of an open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):755-769. doi: 10.1016/S1470-2045(17)30319-4. Epub 2017 May 4.
Results Reference
derived

Learn more about this trial

Combination Chemotherapy in Treating Women With Breast Cancer Who Have Undergone Surgery

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