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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00039546
First received: June 6, 2002
Last updated: August 6, 2013
Last verified: May 2005
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: cyclophosphamide
Drug: epirubicin hydrochloride
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Procedure: adjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039546

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00039546     History of Changes
Other Study ID Numbers: CRC-TU-TANGO, CDR0000069396, EU-20058
Study First Received: June 6, 2002
Last Updated: August 6, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Gemcitabine
Epirubicin
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on July 29, 2014