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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00077168
First received: February 10, 2004
Last updated: February 6, 2009
Last verified: October 2007
  Purpose

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 Intervention Phase
Breast Cancer
Drug: anastrozole
Drug: tamoxifen citrate
Procedure: adjuvant therapy
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Local tumor control (invasive and in situ local recurrence) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mastectomy rate [ Designated as safety issue: No ]
  • Pattern of relapse in the breast [ Designated as safety issue: No ]
  • Contralateral primary [ Designated as safety issue: No ]
  • Breast cancer metastases [ Designated as safety issue: No ]
  • Mortality [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Molecular markers that predict ipsilateral tumor recurrence [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: April 2004
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077168

Locations
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
Queen's Hospital
Derby, England, United Kingdom, DE1 2QY
Derbyshire Royal Infirmary
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
Investigators
Investigator: Ronald Kaggwa Institute of Cancer Research, United Kingdom
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00077168     History of Changes
Other Study ID Numbers: CDR0000349580, ICR-DCIS-II, EU-20341
Study First Received: February 10, 2004
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
ductal breast carcinoma in situ
breast cancer in situ

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Ductal, Breast
Carcinoma, Intraductal, Noninfiltrating
Adenocarcinoma
Breast Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Glandular and Epithelial
Skin Diseases
Anastrozole
Tamoxifen
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Bone Density Conservation Agents
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014