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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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
anastrozole
tamoxifen citrate
adjuvant therapy
radiation therapy
Sponsored by
Institute of Cancer Research, United Kingdom
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring ductal breast carcinoma in situ, breast cancer in situ

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Frenchay Hospital at North Bristol NHS Trust
  • Bristol Haematology and Oncology Centre
  • Broomfield Hospital
  • Chelmsford and Essex Centre
  • Essex County Hospital
  • Derbyshire Royal Infirmary
  • Queen's Hospital
  • Dorset County Hospital
  • St. Luke's Cancer Centre at Royal Surrey County Hospital
  • Leeds Cancer Centre at St. James's University Hospital
  • Lincoln County Hospital
  • Charing Cross Hospital
  • South Manchester University Hospital
  • Clatterbridge Centre for Oncology NHS Trust
  • Milton Keynes General Hospital
  • Derriford Hospital
  • Poole Hospital NHS Trust
  • Berkshire Cancer Centre at Royal Berkshire Hospital
  • Scarborough General Hospital
  • University Hospital of North Tees
  • Royal Marsden NHS Foundation Trust - Surrey
  • Torbay Hospital
  • Hillingdon Hospital
  • Worcester Royal Hospital
  • Aberdeen Royal Infirmary at NHS Grampian
  • Ninewells Hospital
  • University of Glasgow
  • Ysbyty Gwynedd
  • University Hospital of Wales

Outcomes

Primary Outcome Measures

Local tumor control (invasive and in situ local recurrence)

Secondary Outcome Measures

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

Full Information

First Posted
February 10, 2004
Last Updated
February 6, 2009
Sponsor
Institute of Cancer Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT00077168
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2004 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Institute of Cancer Research, United Kingdom

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
ductal breast carcinoma in situ, breast cancer in situ

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
anastrozole
Intervention Type
Drug
Intervention Name(s)
tamoxifen citrate
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Local tumor control (invasive and in situ local recurrence)
Secondary Outcome Measure Information:
Title
Mastectomy rate
Title
Pattern of relapse in the breast
Title
Contralateral primary
Title
Breast cancer metastases
Title
Mortality
Title
Quality of life
Title
Molecular markers that predict ipsilateral tumor recurrence

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Kaggwa
Organizational Affiliation
Institute of Cancer Research, United Kingdom
Facility Information:
Facility Name
Frenchay Hospital at North Bristol NHS Trust
City
Bristol
State/Province
England
ZIP/Postal Code
BS16 1LE
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Broomfield Hospital
City
Broomefield
State/Province
England
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Facility Name
Chelmsford and Essex Centre
City
Chelmsford
State/Province
England
ZIP/Postal Code
CM2 0QH
Country
United Kingdom
Facility Name
Essex County Hospital
City
Colchester
State/Province
England
ZIP/Postal Code
C03 3NB
Country
United Kingdom
Facility Name
Derbyshire Royal Infirmary
City
Derby
State/Province
England
ZIP/Postal Code
DE1 2QY
Country
United Kingdom
Facility Name
Queen's Hospital
City
Derby
State/Province
England
ZIP/Postal Code
DE1 2QY
Country
United Kingdom
Facility Name
Dorset County Hospital
City
Dorchester
State/Province
England
ZIP/Postal Code
DT1 2JY
Country
United Kingdom
Facility Name
St. Luke's Cancer Centre at Royal Surrey County Hospital
City
Guildford
State/Province
England
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Lincoln County Hospital
City
Lincoln
State/Province
England
ZIP/Postal Code
LN2 5QY
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
South Manchester University Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology NHS Trust
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Milton Keynes General Hospital
City
Milton Keynes
State/Province
England
ZIP/Postal Code
MK6 5LD
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
State/Province
England
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Poole Hospital NHS Trust
City
Poole Dorset
State/Province
England
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
Berkshire Cancer Centre at Royal Berkshire Hospital
City
Reading
State/Province
England
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
Scarborough General Hospital
City
Scarborough
State/Province
England
ZIP/Postal Code
YO12 6QL
Country
United Kingdom
Facility Name
University Hospital of North Tees
City
Stockton-On-Tees
State/Province
England
ZIP/Postal Code
TS19 8PE
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Torbay Hospital
City
Torquay Devon
State/Province
England
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Hillingdon Hospital
City
Uxbridge
State/Province
England
ZIP/Postal Code
UB8 3NN
Country
United Kingdom
Facility Name
Worcester Royal Hospital
City
Worcester
State/Province
England
ZIP/Postal Code
WR5 1DD
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary at NHS Grampian
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
University of Glasgow
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Ysbyty Gwynedd
City
Bangor
State/Province
Wales
ZIP/Postal Code
LL57 2PW
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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