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

August 6, 2013 updated by: Cancer Research Campaign Clinical Trials Centre

'tAnGo', A Phase III Randomised Trial Of Gemcitabine In Paclitaxel-Containing, Epirubicin-Based, Adjuvant Chemotherapy For ER/PgR-Poor, Early Stage, Breast Cancer

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.

Study Overview

Status

Unknown

Conditions

Breast Cancer

Intervention / Treatment

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.

Study Type

Interventional

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- - East Kilbride, United Kingdom, G75 8RG
    - Hairmyres Hospital
  - Hull, United Kingdom, HU3 2KZ
    - Hull Royal Infirmary
  - King's Lynn, United Kingdom, PE30 4ET
    - Queen Elizabeth Hospital
  - Rhyl, Denbighshire, United Kingdom, LL 18 5UJ
    - Glan Clywd District General Hospital
  - Swansea, United Kingdom, SA 2 8QA
    - Singleton Hospital
  - West Glamorgen, United Kingdom, SA6 6NL
    - Morriston Hospital NHS Trust
- England
  - Birmingham, England, United Kingdom, B15 2TH
    - Queen Elizabeth Hospital at University of Birmingham
  - Birmingham, England, United Kingdom, B18 7QH
    - City Hospital - Birmingham
  - Birmingham, England, United Kingdom, B15 2TT
    - Cancer Research UK Clinical Trials Unit - Birmingham
  - Birmingham, England, United Kingdom, B9 5SS
    - Birmingham Heartlands and Solihull NHS Trust -Teaching
  - Burton-upon-Trent, England, United Kingdom, DE14 3QH
    - Queen's Hospital, Burton
  - Cambridge, England, United Kingdom, CB2 2QQ
    - Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
  - Chelmsford, Essex, England, United Kingdom, CM1 5ET
    - Broomfield Hospital
  - Colchester, England, United Kingdom, C03 3NB
    - Essex County Hospital
  - Coventry, England, United Kingdom, CV2 2DX
    - Walsgrave Hospital
  - Dorchester, England, United Kingdom, DT1 2JY
    - Dorset County Hospital
  - Exeter, England, United Kingdom, EX2 5DW
    - Royal Devon and Exeter Hospital
  - Hull, England, United Kingdom, HU8 9HE
    - Princess Royal Hospital
  - Huntingdon, England, United Kingdom, PE18 6NT
    - Hinchingbrooke Hospital
  - Ilford, Essex, England, United Kingdom, IG3 8YB
    - King George Hospital
  - Kilmarnock, England, United Kingdom, KA2 OBE
    - Crosshouse Hospital
  - Leeds, England, United Kingdom, LS9 7TF
    - Leeds Cancer Centre at St. James's University Hospital
  - Leeds, England, United Kingdom, LS16 6QB
    - Cookridge Hospital at Leeds Teaching Hospital NHS Trust
  - London, England, United Kingdom, SW17 0QT
    - St. George's Hospital
  - Manchester, England, United Kingdom, M20 4BX
    - Christie Hospital N.H.S. Trust
  - Merseyside, England, United Kingdom, L63 4JY
    - Clatterbridge Centre for Oncology NHS Trust
  - Middlesbrough, England, United Kingdom, TS4 3BW
    - James Cook University Hospital
  - Newcastle-upon-Tyne, England, United Kingdom, NE4 6BE
    - Northern Centre for Cancer Treatment at Newcastle General Hospital
  - Northampton, England, United Kingdom
    - Northampton General Hospital NHS Trust
  - Nottingham, England, United Kingdom, NG5 1PB
    - Nottingham City Hospital NHS Trust
  - Peterborough, England, United Kingdom, PE3 6DA
    - Peterborough Hospitals Trust
  - Plymouth, England, United Kingdom, PL6 8DH
    - Derriford Hospital
  - Romford, England, United Kingdom, RM7 OBE
    - Oldchurch Hospital
  - Sheffield, England, United Kingdom, S1O 2SJ
    - Cancer Research Centre at Weston Park Hospital
  - Sheffield, England, United Kingdom, S10 3BR
    - Thornbury Hospital
  - Shrewsbury, England, United Kingdom
    - Royal Shrewsbury Hospital
  - Suffolk, England, United Kingdom, IP33 2QZ
    - West Suffolk Hospital
  - Torquay Devon, England, United Kingdom, TQ2 7AA
    - Torbay Hospital
  - Walsall, England, United Kingdom, WS2 9PS
    - Walsall Manor Hospital
  - West Bromwich, England, United Kingdom, B71 4HJ
    - Sandwell General Hospital
  - West Midlands, England, United Kingdom, B75 7RR
    - Good Hope Hospital Trust
  - Worcester, England, United Kingdom, WR5 1JG
    - Worcester Royal Hospital
- Scotland
  - Edinburgh, Scotland, United Kingdom, EH4 2XU
    - Western General Hospital
  - Glasgow, Scotland, United Kingdom, G4 0SF
    - Royal Infirmary - Castle
  - Glasgow, Scotland, United Kingdom, G11 6NT
    - Beatson Oncology Centre
- Wales
  - Cardiff, Wales, United Kingdom, CF4 7XL
    - Velindre Cancer Center at Velinde Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Research Campaign Clinical Trials Centre

Investigators

Study Chair: Helen Howard, PhD, Cancer Research Campaign Clinical Trials Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Study Registration Dates

First Submitted

June 6, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

May 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CRC-TU-TANGO
CDR0000069396 (Registry Identifier: PDQ (Physician Data Query))
EU-20058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.