Adjuvant Radiation Therapy Compared With Observation After Surgery in Treating Women With Estrogen Receptor Positive or Progesterone Receptor Positive Ductal Carcinoma In Situ of the Breast Who Are Receiving Tamoxifen or Anastrozole

February 6, 2009 updated by: Institute of Cancer Research, United Kingdom

Randomised Trial Testing Observation (No Radiotherapy) Against Radiotherapy In Women With Low-Risk Completely Excised ER Positive Ductal Carcinoma In Situ (DCIS) Of The Breast On Adjuvant Endocrine Therapy

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy after surgery is effective in preventing a recurrence of ductal carcinoma in situ.

PURPOSE: This randomized phase II trial is studying adjuvant radiation therapy to see how well it works compared to observation after surgery in treating women with estrogen receptor positive or progesterone receptor positive ductal carcinoma in situ and are also receiving either tamoxifen or anastrozole.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Compare ipsilateral tumor relapse and breast cancer metastases in women with completely excised low-risk estrogen receptor- or progesterone receptor-positive ductal carcinoma in situ of the breast receiving adjuvant tamoxifen or anastrozole and treated with adjuvant radiotherapy vs observation alone.
  • Compare the quality of life of patients treated with these regimens.

Secondary

  • Determine the minimal surgical margins required to minimize the local recurrence rate in patients treated with these regimens.
  • Identify molecular markers that predict ipsilateral tumor recurrence in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

All patients receive adjuvant tamoxifen or anastrozole for 5 years.

  • Arm I: Patients undergo radiotherapy 5 days a week for 3 or 5 weeks.
  • Arm II: Patients undergo observation alone. Quality of life is assessed at baseline, at 6 months, and then at 1, 2, and 5 years.

Patients are followed every 6 months for 1 year and then annually for up to 10 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 2,000 patients (1,000 per treatment arm) will be accrued for this study within 5 years.

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Bristol, England, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology centre
      • Bristol, England, United Kingdom, BS16 1LE
        • Frenchay Hospital at North Bristol NHS Trust
      • Broomefield, England, United Kingdom, CM1 7ET
        • Broomfield Hospital
      • Chelmsford, England, United Kingdom, CM2 0QH
        • Chelmsford and Essex Centre
      • Colchester, England, United Kingdom, C03 3NB
        • Essex County Hospital
      • Derby, England, United Kingdom, DE1 2QY
        • Derbyshire Royal Infirmary
      • Derby, England, United Kingdom, DE1 2QY
        • Queen's Hospital
      • Dorchester, England, United Kingdom, DT1 2JY
        • Dorset County Hospital
      • Guildford, England, United Kingdom, GU2 7XX
        • St. Luke's Cancer Centre at Royal Surrey County Hospital
      • Leeds, England, United Kingdom, LS9 7TF
        • Leeds Cancer Centre at St. James's University Hospital
      • Lincoln, England, United Kingdom, LN2 5QY
        • Lincoln County Hospital
      • London, England, United Kingdom, W6 8RF
        • Charing Cross Hospital
      • Manchester, England, United Kingdom, M23 9LT
        • South Manchester University Hospital
      • Merseyside, England, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology NHS Trust
      • Milton Keynes, England, United Kingdom, MK6 5LD
        • Milton Keynes General Hospital
      • Plymouth, England, United Kingdom, PL6 8DH
        • Derriford Hospital
      • Poole Dorset, England, United Kingdom, BH15 2JB
        • Poole Hospital NHS Trust
      • Reading, England, United Kingdom, RG1 5AN
        • Berkshire Cancer Centre at Royal Berkshire Hospital
      • Scarborough, England, United Kingdom, YO12 6QL
        • Scarborough General Hospital
      • Stockton-On-Tees, England, United Kingdom, TS19 8PE
        • University Hospital of North Tees
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden NHS Foundation Trust - Surrey
      • Torquay Devon, England, United Kingdom, TQ2 7AA
        • Torbay Hospital
      • Uxbridge, England, United Kingdom, UB8 3NN
        • Hillingdon Hospital
      • Worcester, England, United Kingdom, WR5 1DD
        • Worcester Royal Hospital
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary at NHS Grampian
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • University of Glasgow
    • Wales
      • Bangor, Wales, United Kingdom, LL57 2PW
        • Ysbyty Gwynedd
      • Cardiff, Wales, United Kingdom, CF14 4XW
        • University Hospital of Wales

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of unifocal ductal carcinoma in situ of the breast without an invasive component

    • Microinvasion (defined as 1 or more foci of invasion each < 1 mm) allowed
  • Prior complete microscopic excision (within the past 6 months) with a minimum radial margin of 1 mm by specimen x-ray required
  • Maximum microscopic tumor diameter < 30 mm (< 15 mm if grade 3 tumor)

  • Planning to receive adjuvant tamoxifen or anastrozole for 5 years

    • Eligible patients may receive adjuvant endocrine therapy on ICR-IBIS-II

  • Hormone receptor status:

    • Estrogen receptor positive OR
    • Progesterone receptor positive
    • More than 10% tumor staining for receptor OR a cutpoint of ≥ 2

PATIENT CHARACTERISTICS:

Sex

  • Female

Menopausal status

  • Premenopausal, perimenopausal, or postmenopausal

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Cardiovascular

  • No prior deep vein thrombosis

Pulmonary

  • No prior pulmonary embolus

Other

  • No unexplained postmenopausal bleeding
  • No contraindication to full-dose radiotherapy to the breast
  • No other cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • See Disease Characteristics
  • No prior tamoxifen or raloxifene use for more than 3 months in duration

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics
  • No prior mastectomy

Other

  • No concurrent anticoagulants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Local tumor control (invasive and in situ local recurrence)

Secondary Outcome Measures

Outcome Measure
Quality of life
Mortality
Mastectomy rate
Pattern of relapse in the breast
Contralateral primary
Breast cancer metastases
Molecular markers that predict ipsilateral tumor recurrence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cancer Research, United Kingdom

Investigators

  • Ronald Kaggwa, Institute of Cancer Research, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

February 10, 2004

First Submitted That Met QC Criteria

February 10, 2004

First Posted (Estimate)

February 11, 2004

Study Record Updates

Last Update Posted (Estimate)

February 9, 2009

Last Update Submitted That Met QC Criteria

February 6, 2009

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000349580
  • ICR-DCIS-II
  • EU-20341

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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