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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00039546
• Other study ID #: CRC-TU-TANGO
• Secondary ID: CDR0000069396EU-
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 6, 2002
• Last updated: August 6, 2013
• Start date: August 2001

Study information

• Verified date: May 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• cyclophosphamide

• epirubicin hydrochloride

• gemcitabine hydrochloride

• paclitaxel

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
United Kingdom	Birmingham Heartlands and Solihull NHS Trust -Teaching	Birmingham	England
United Kingdom	Cancer Research UK Clinical Trials Unit - Birmingham	Birmingham	England
United Kingdom	City Hospital - Birmingham	Birmingham	England
United Kingdom	Queen Elizabeth Hospital at University of Birmingham	Birmingham	England
United Kingdom	Queen's Hospital, Burton	Burton-upon-Trent	England
United Kingdom	Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust	Cambridge	England
United Kingdom	Velindre Cancer Center at Velinde Hospital	Cardiff	Wales
United Kingdom	Broomfield Hospital	Chelmsford, Essex	England
United Kingdom	Essex County Hospital	Colchester	England
United Kingdom	Walsgrave Hospital	Coventry	England
United Kingdom	Dorset County Hospital	Dorchester	England
United Kingdom	Hairmyres Hospital	East Kilbride
United Kingdom	Western General Hospital	Edinburgh	Scotland
United Kingdom	Royal Devon and Exeter Hospital	Exeter	England
United Kingdom	Beatson Oncology Centre	Glasgow	Scotland
United Kingdom	Royal Infirmary - Castle	Glasgow	Scotland
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	Princess Royal Hospital	Hull	England
United Kingdom	Hinchingbrooke Hospital	Huntingdon	England
United Kingdom	King George Hospital	Ilford, Essex	England
United Kingdom	Crosshouse Hospital	Kilmarnock	England
United Kingdom	Queen Elizabeth Hospital	King's Lynn
United Kingdom	Cookridge Hospital at Leeds Teaching Hospital NHS Trust	Leeds	England
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	St. George's Hospital	London	England
United Kingdom	Christie Hospital N.H.S. Trust	Manchester	England
United Kingdom	Clatterbridge Centre for Oncology NHS Trust	Merseyside	England
United Kingdom	James Cook University Hospital	Middlesbrough	England
United Kingdom	Northern Centre for Cancer Treatment at Newcastle General Hospital	Newcastle-upon-Tyne	England
United Kingdom	Northampton General Hospital NHS Trust	Northampton	England
United Kingdom	Nottingham City Hospital NHS Trust	Nottingham	England
United Kingdom	Peterborough Hospitals Trust	Peterborough	England
United Kingdom	Derriford Hospital	Plymouth	England
United Kingdom	Glan Clywd District General Hospital	Rhyl, Denbighshire
United Kingdom	Oldchurch Hospital	Romford	England
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield	England
United Kingdom	Thornbury Hospital	Sheffield	England
United Kingdom	Royal Shrewsbury Hospital	Shrewsbury	England
United Kingdom	West Suffolk Hospital	Suffolk	England
United Kingdom	Singleton Hospital	Swansea
United Kingdom	Torbay Hospital	Torquay Devon	England
United Kingdom	Walsall Manor Hospital	Walsall	England
United Kingdom	Sandwell General Hospital	West Bromwich	England
United Kingdom	Morriston Hospital NHS Trust	West Glamorgen
United Kingdom	Good Hope Hospital Trust	West Midlands	England
United Kingdom	Worcester Royal Hospital	Worcester	England

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research Campaign Clinical Trials Centre

Country where clinical trial is conducted

United Kingdom,