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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00077168
Recruitment Status : Unknown
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : February 11, 2004
Last Update Posted : February 9, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: anastrozole Drug: tamoxifen citrate Procedure: adjuvant therapy Radiation: radiation therapy Phase 2

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2004
Estimated Primary Completion Date : September 2017

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Local tumor control (invasive and in situ local recurrence)

Secondary Outcome Measures :
  1. Mastectomy rate
  2. Pattern of relapse in the breast
  3. Contralateral primary
  4. Breast cancer metastases
  5. Mortality
  6. Quality of life
  7. Molecular markers that predict ipsilateral tumor recurrence

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • Female

Menopausal status

  • Premenopausal, perimenopausal, or postmenopausal

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No prior deep vein thrombosis


  • No prior pulmonary embolus


  • 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


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

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


  • Not specified


  • See Disease Characteristics
  • No prior mastectomy


  • No concurrent anticoagulants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00077168

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

Layout table for additonal information Identifier: NCT00077168     History of Changes
Other Study ID Numbers: CDR0000349580
First Posted: February 11, 2004    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: October 2007
Keywords provided by National Cancer Institute (NCI):
ductal breast carcinoma in situ
breast cancer in situ
Additional relevant MeSH terms:
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Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors