NCT00002579

Brief Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combining combination chemotherapy with hormone therapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without tamoxifen in treating women with stage I or stage II breast cancer that can be surgically removed.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for phase_3 breast-cancer

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1993

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.8 years until next milestone

First Posted

Study publicly available on registry

August 23, 2004

Completed
Last Updated

November 6, 2013

Status Verified

May 1, 2007

First QC Date

November 1, 1999

Last Update Submit

November 5, 2013

Conditions

Breast Cancer

Keywords

stage I breast cancerstage II breast cancerstage IIIA breast cancer

Interventions

CMF regimenDRUG
cyclophosphamideDRUG
fluorouracilDRUG
methotrexateDRUG
tamoxifen citrateDRUG
conventional surgeryPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed breast cancer with palpable, unilateral, invasive disease Bilateral mammography required within 1 year prior to randomization TNM Stage T1-3, N0-1, M0 disease for which adjuvant chemotherapy is considered an essential part of initial therapy No prior pure in situ carcinoma in either breast No concurrent in situ carcinoma only No Paget's disease of the nipple without underlying invasion No evidence of distant disease, e.g.: No ipsilateral supraclavicular node enlargement unless proven benign Hormone receptor status: Any status PATIENT CHARACTERISTICS: Age: Not specified Sex: Women only Menopausal status: Pre- or postmenopausal Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No serious unrelated illness No prior invasive malignancy at any other site except adequately treated nonmelanomatous skin cancer No pregnant or nursing women Adequate contraception required PRIOR CONCURRENT THERAPY: No prior tamoxifen and not currently receiving tamoxifen

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

Sponsors & Collaborators

Study Sites (10)

Leicester Royal Infirmary NHS Trust

Leicester, England, LE1 5WW, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Western General Hospital

Edinburgh, Scotland, EH4 9NQ, United Kingdom

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

University of Glasgow

Glasgow, Scotland, G61 1BD, United Kingdom

Location

Raigmore Hospital

Inverness, Scotland, 1V2 3UJ, United Kingdom

Location

Royal Alexandra Hospital

Paisley, Scotland, United Kingdom

Location

Ayr Hospital

Ayr, KA6 6DX, United Kingdom

Location

Falkirk Royal Infirmary

Falkirk, FK1 5RE, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CMF regimenCyclophosphamideFluorouracilMethotrexateTamoxifenRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicTherapeutics

Study Officials

  • W.D. George, MD, MS, FRCS

    University of Glasgow

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 23, 2004

Study Start

March 1, 1993

Last Updated

November 6, 2013

Record last verified: 2007-05

Locations

GB(10)