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

NCT00039546 | Unknown Phase 3

• 3 other identifiers: CRC-TU-TANGOCDR0000069396EU-20058
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 46

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.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer

Interventions

cyclophosphamide DRUG

epirubicin hydrochloride DRUG

gemcitabine hydrochloride DRUG

paclitaxel DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Research Campaign Clinical Trials Centre: lead

Study Sites (46)

Queen Elizabeth Hospital at University of Birmingham

Birmingham, England, B15 2TH, United Kingdom

Location

Cancer Research UK Clinical Trials Unit - Birmingham

Birmingham, England, B15 2TT, United Kingdom

Location

City Hospital - Birmingham

Birmingham, England, B18 7QH, United Kingdom

Location

Birmingham Heartlands and Solihull NHS Trust -Teaching

Birmingham, England, B9 5SS, United Kingdom

Location

Queen's Hospital, Burton

Burton-on-Trent, England, DE14 3QH, United Kingdom

Location

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

Broomfield Hospital

Chelmsford, Essex, England, CM1 5ET, United Kingdom

Location

Essex County Hospital

Colchester, England, C03 3NB, United Kingdom

Location

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

Dorset County Hospital

Dorchester, England, DT1 2JY, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Princess Royal Hospital

Hull, England, HU8 9HE, United Kingdom

Location

Hinchingbrooke Hospital

Huntingdon, England, PE18 6NT, United Kingdom

Location

King George Hospital

Ilford, Essex, England, IG3 8YB, United Kingdom

Location

Crosshouse Hospital

Kilmarnock, England, KA2 OBE, United Kingdom

Location

Cookridge Hospital at Leeds Teaching Hospital NHS Trust

Leeds, England, LS16 6QB, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

St. George's Hospital

London, England, SW17 0QT, United Kingdom

Location

Christie Hospital N.H.S. Trust

Manchester, England, M20 4BX, United Kingdom

Location

Clatterbridge Centre for Oncology NHS Trust

Merseyside, England, L63 4JY, United Kingdom

Location

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

Location

Northern Centre for Cancer Treatment at Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Northampton General Hospital NHS Trust

Northampton, England, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Peterborough Hospitals Trust

Peterborough, England, PE3 6DA, United Kingdom

Location

Derriford Hospital

Plymouth, England, PL6 8DH, United Kingdom

Location

Oldchurch Hospital

Romford, England, RM7 OBE, United Kingdom

Location

Thornbury Hospital

Sheffield, England, S10 3BR, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Royal Shrewsbury Hospital

Shrewsbury, England, United Kingdom

Location

West Suffolk Hospital

Suffolk, England, IP33 2QZ, United Kingdom

Location

Torbay Hospital

Torquay Devon, England, TQ2 7AA, United Kingdom

Location

Walsall Manor Hospital

Walsall, England, WS2 9PS, United Kingdom

Location

Sandwell General Hospital

West Bromwich, England, B71 4HJ, United Kingdom

Location

Good Hope Hospital Trust

West Midlands, England, B75 7RR, United Kingdom

Location

Worcester Royal Hospital

Worcester, England, WR5 1JG, United Kingdom

Location

Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Royal Infirmary - Castle

Glasgow, Scotland, G4 0SF, United Kingdom

Location

Velindre Cancer Center at Velinde Hospital

Cardiff, Wales, CF4 7XL, United Kingdom

Location

Hairmyres Hospital

East Kilbride, G75 8RG, United Kingdom

Location

Hull Royal Infirmary

Hull, HU3 2KZ, United Kingdom

Location

Queen Elizabeth Hospital

Kings Lynn, PE30 4ET, United Kingdom

Location

Glan Clywd District General Hospital

Rhyl, Denbighshire, LL 18 5UJ, United Kingdom

Location

Singleton Hospital

Swansea, SA 2 8QA, United Kingdom

Location

Morriston Hospital NHS Trust

West Glamorgen, SA6 6NL, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 28479233 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Epirubicin; Gemcitabine; Paclitaxel; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Helen Howard, PhD

  Cancer Research Campaign Clinical Trials Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 6, 2002
• First Posted: January 27, 2003
• Study Start: August 1, 2001
• Last Updated: August 7, 2013

Record last verified: 2005-05

Locations

GB (46)