Clinical trial NCT00039546: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: stage I breast cancer
stage II breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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

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