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Combination Chemotherapy in T...

Combination Chemotherapy in Treating Patients With Early Stage Breast Cancer That Has Been Removed By Surgery

NCT ID: NCT00301925

Last Updated: 2018-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

4400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-16

Study Completion Date

2024-09-30

Brief Summary

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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating early stage breast cancer that has been removed by surgery.

PURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens to compare how well they work in treating patients with early stage breast cancer that has been removed by surgery.

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Detailed Description

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OBJECTIVES:

Primary

* Compare the disease-free survival (DFS) of patients with completely resected early stage breast cancer receiving 1 of 2 different schedules of adjuvant chemotherapy comprising epirubicin, cyclophosphamide, methotrexate, and fluorouracil versus 1 of 2 different schedules of adjuvant chemotherapy comprising epirubicin and capecitabine.

Secondary

* Compare overall survival (OS) and distant disease-free survival (DFS).
* Compare the tolerability (including serious adverse events \[SAE\], dose-intensity, and toxicity) of these regimens.
* Determine the detailed toxicity of these regimens.
* Determine the quality of life of a subset of these patients.

OUTLINE: This is a multi-center, randomized study. Patients are stratified according to participating center, nodal status (N0 vs N1-3 vs N≥ 4), age (≤ 50 years vs \> 50 years), and estrogen receptor (ER) status (negative vs positive). Patients are randomized to 1 of 4 treatment arms.

* Arm I: Patients receive epirubicin on day 1. Treatment repeats every 3 weeks for 4 courses. Patients then receive cyclophosphamide orally once daily on days 1-14 or IV on days 1 and 8 and methotrexate and fluorouracil on days 1 and 8. Treatment repeats every 28 days for 4 courses.
* Arm II: Patients receive epirubicin on day 1 and pegfilgrastim on day 2. Treatment repeats every 2 weeks for 4 courses. Patients then receive cyclophosphamide, methotrexate and fluorouracil as in arm I.
* Arm III: Patients receive epirubicin as in arm I. Patients then receive oral capecitabine twice daily on days 1-14. Treatment with capecitabine repeats every 3 weeks for 4 courses.
* Arm IV: Patients receive epirubicin and pegfilgrastim as in arm II. Patients then receive capecitabine as in arm III.

In all arms, treatment continues in the absence of unacceptable toxicity.

Beginning 3-6 months later, all patients may undergo radiotherapy at the discretion of the principal investigator. Patients with ER- and/or progesterone receptor-positive disease then receive tamoxifen citrate or an aromatase inhibitor for up to 5 years.

Quality of life is assessed in a cohort of 1,000 patients in week 6, week 8 or 12, and week 20 or 24 during treatment and then at 12 and 24 months after randomization.

After completion of study therapy, patients are followed every 6 months for 2 years and then annually for at least 10 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

PROJECTED ACCRUAL: A total of 4,400 patients will be accrued for this study.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Study Groups

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Epi-CMF

Group Type ACTIVE_COMPARATOR

cyclophosphamide

Intervention Type DRUG

epirubicin hydrochloride

Intervention Type DRUG

fluorouracil

Intervention Type DRUG

methotrexate

Intervention Type DRUG

adjuvant therapy

Intervention Type PROCEDURE

Accelerated Epi-CMF

Group Type EXPERIMENTAL

pegfilgrastim

Intervention Type BIOLOGICAL

cyclophosphamide

Intervention Type DRUG

epirubicin hydrochloride

Intervention Type DRUG

fluorouracil

Intervention Type DRUG

methotrexate

Intervention Type DRUG

adjuvant therapy

Intervention Type PROCEDURE

Epi-Capecitabine

Group Type EXPERIMENTAL

capecitabine

Intervention Type DRUG

epirubicin hydrochloride

Intervention Type DRUG

adjuvant therapy

Intervention Type PROCEDURE

Accelerated Epi-Capecitabine

Group Type EXPERIMENTAL

pegfilgrastim

Intervention Type BIOLOGICAL

capecitabine

Intervention Type DRUG

epirubicin hydrochloride

Intervention Type DRUG

adjuvant therapy

Intervention Type PROCEDURE

Interventions

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pegfilgrastim

Intervention Type BIOLOGICAL

capecitabine

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

epirubicin hydrochloride

Intervention Type DRUG

fluorouracil

Intervention Type DRUG

methotrexate

Intervention Type DRUG

adjuvant therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histological diagnosis of invasive breast carcinoma

* Cytological proof of malignancy alone is not sufficient
* Early stage disease (T0-3, N0-2, M0) without clinical suspicion or evidence of distant metastases on routine staging
* No locally advanced breast cancer (T4 and/or N3 disease)
* Completely resected disease by breast-conserving surgery with axillary node clearance or modified radical mastectomy within the past 4-8 weeks

* Negative surgical margins required, unless either of the following are true:

* Deep surgical margins after full thickness resection
* Noninvasive cancer at surgical margins for which a mastectomy is planned after completion of study chemotherapy
* No contraindication for or refusal of postoperative radiotherapy in patients who underwent prior breast-conserving surgery
* Definite indication for adjuvant chemotherapy
* No prior or current invasive breast cancer or bilateral breast cancer

* Prior surgically-treated ductal carcinoma in situ or lobular carcinoma in situ allowed
* Hormone receptor status:

* Estrogen receptor- and/or progesterone receptor-positive or -negative tumor

PATIENT CHARACTERISTICS:

* Sex: male or female
* Menopausal status: premenopausal or postmenopausal
* No previous malignancy except basal cell carcinoma, carcinoma in situ of the cervix, or any cancer from which the patient has been disease-free for 10 years and for which treatment consisted solely of resection
* ECOG status 0 or 1
* Hemoglobin \> 9 g/dL
* WBC \> 3,000/mm³
* Platelet count \> 10,000/mm³
* Bilirubin normal (unless due to known Gilbert's disease)
* AST and ALT ≤ 1.5 times upper limit of normal (ULN)
* Albumin normal
* Creatinine ≤ 1.5 times ULN
* Creatinine clearance \> 50 mL/min
* No active, uncontrolled infection
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No concurrent medical, psychiatric, or geographic problems that might prevent completion of treatment or follow-up
* Available for a minimum of 5 years' follow-up
* No known serious viral infection such as active hepatitis B, hepatitis C, or HIV
* No significant cardiac disease, such as impaired left ventricular function or active angina requiring regular anti-anginal medication and/or resulting in restricted physical activity
* No history of significant renal impairment or disease

PRIOR CONCURRENT THERAPY:

* No simultaneous participation in the active intervention phase of another treatment trial
* Not being approached or recruited for another trial within 2 months of study entry
* No previous chemotherapy, hormonal therapy or radiotherapy for the treatment of pre-invasive or invasive cancer except for either of the following:

* Previous radiotherapy for basal cell carcinoma
* Previous preoperative endocrine therapy, provided there was no evidence of progression during this therapy, it lasted for less than 6 weeks in duration, and it was stopped at least one month prior to trial entry
* Concurrent luteinizing hormone-releasing hormone analog therapy allowed for premenopausal patients
* More than 4 weeks since prior hormone replacement therapy (HRT) or pre-operative endocrine therapy
* No prior breast conserving surgery if there is a contradiction for or refusal of postoperative radiotherapy

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Cameron, MD

Role: STUDY_CHAIR

National Cancer Research Network

Locations

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William Harvey Hospital

Ashford-Kent, England, United Kingdom

Site Status

Wansbeck General Hospital

Ashington, England, United Kingdom

Site Status

Tameside General Hospital

Ashton-under-Lyne, England, United Kingdom

Site Status

North Devon District Hospital

Barnstaple, England, United Kingdom

Site Status

Furness General Hospital

Barrow in Furness, England, United Kingdom

Site Status

Basildon University Hospital

Basildon, England, United Kingdom

Site Status

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, England, United Kingdom

Site Status

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, United Kingdom

Site Status

City Hospital - Birmingham

Birmingham, England, United Kingdom

Site Status

Birmingham Heartlands Hospital

Birmingham, England, United Kingdom

Site Status

Royal Blackburn Hospital

Blackburn, England, United Kingdom

Site Status

Blackpool Victoria Hospital

Blackpool, England, United Kingdom

Site Status

Royal Bolton Hospital

Bolton, Lancashire, England, United Kingdom

Site Status

Bradford Royal Infirmary

Bradford, England, United Kingdom

Site Status

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, United Kingdom

Site Status

Bristol Haematology and Oncology Centre

Bristol, England, United Kingdom

Site Status

Broomfield Hospital

Broomefield, England, United Kingdom

Site Status

Burnley General Hospital

Burnley, England, United Kingdom

Site Status

Queen's Hospital

Burton-on-Trent, England, United Kingdom

Site Status

West Suffolk Hospital

Bury St Edmunds, England, United Kingdom

Site Status

Addenbrooke's Hospital

Cambridge, England, United Kingdom

Site Status

Kent and Canterbury Hospital

Canterbury, England, United Kingdom

Site Status

Cheltenham General Hospital

Cheltenham, England, United Kingdom

Site Status

Halton Hospital

Cheshire, England, United Kingdom

Site Status

Chesterfield Royal Hospital

Chesterfield, England, United Kingdom

Site Status

Saint Richards Hospital

Chichester, England, United Kingdom

Site Status

Essex County Hospital

Colchester, England, United Kingdom

Site Status

Walsgrave Hospital

Coventry, England, United Kingdom

Site Status

Darent Valley Hospital

Dartford Kent, England, United Kingdom

Site Status

Derbyshire Royal Infirmary

Derby, England, United Kingdom

Site Status

Dewsbury and District Hospital

Dewsbury, England, United Kingdom

Site Status

Doncaster Royal Infirmary

Doncaster, England, United Kingdom

Site Status

Russells Hall Hospital

Dudley, England, United Kingdom

Site Status

University Hospital of North Durham

Durham, England, United Kingdom

Site Status

Eastbourne District General Hospital

Eastbourne, England, United Kingdom

Site Status

Royal Devon and Exeter Hospital

Exeter, England, United Kingdom

Site Status

Queen Elizabeth Hospital

Gateshead, England, United Kingdom

Site Status

Gloucestershire Royal Hospital

Gloucester, England, United Kingdom

Site Status

Diana Princess of Wales Hospital

Grimsby, England, United Kingdom

Site Status

St. Luke's Cancer Centre at Royal Surrey County Hospital

Guildford, England, United Kingdom

Site Status

UCL Cancer Institute

Hampstead, London, England, United Kingdom

Site Status

Hereford Hospitals NHS Trust

Hereford, England, United Kingdom

Site Status

Wycombe General Hospital

High Wycombe, England, United Kingdom

Site Status

Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, United Kingdom

Site Status

Princess Royal Hospital at Hull and East Yorkshire NHS Trust

Hull, England, United Kingdom

Site Status

King George Hospital

Ilford, Essex, England, United Kingdom

Site Status

Ipswich Hospital

Ipswich, England, United Kingdom

Site Status

West Middlesex University Hospital

Isleworth, England, United Kingdom

Site Status

Airedale General Hospital

Keighley, England, United Kingdom

Site Status

Kettering General Hosptial

Kettering, Northants, England, United Kingdom

Site Status

Kidderminster Hospital

Kidderminster Worcestershire, England, United Kingdom

Site Status

Queen Elizabeth Hospital

Kings Lynn, England, United Kingdom

Site Status

Royal Albert Edward Infirmary

Lancanshire, England, United Kingdom

Site Status

Royal Lancaster Infirmary

Lancaster, England, United Kingdom

Site Status

Cookridge Hospital

Leeds, England, United Kingdom

Site Status

National Cancer Research Network

Leeds, England, United Kingdom

Site Status

Cancer Research UK Clinical Centre at St. James's University Hospital

Leeds, England, United Kingdom

Site Status

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, United Kingdom

Site Status

Royal Liverpool University Hospital

Liverpool, England, United Kingdom

Site Status