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

NCT00077168 | Unknown Phase 2

• 3 other identifiers: CDR0000349580ICR-DCIS-IIEU-20341
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 29

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.

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situ; breast cancer in situ

Outcome Measures

Primary Outcomes (1)

• Local tumor control (invasive and in situ local recurrence)

Secondary Outcomes (7)

• Mastectomy rate

• Pattern of relapse in the breast

• Contralateral primary

• Breast cancer metastases

• Mortality

Interventions

anastrozole DRUG

tamoxifen citrate DRUG

adjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead

Study Sites (29)

Frenchay Hospital at North Bristol NHS Trust

Bristol, England, BS16 1LE, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Broomfield Hospital

Broomefield, England, CM1 7ET, United Kingdom

Location

Chelmsford and Essex Centre

Chelmsford, England, CM2 0QH, United Kingdom

Location

Essex County Hospital

Colchester, England, C03 3NB, United Kingdom

Location

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

Location

Queen's Hospital

Derby, England, DE1 2QY, United Kingdom

Location

Dorset County Hospital

Dorchester, England, DT1 2JY, United Kingdom

Location

St. Luke's Cancer Centre at Royal Surrey County Hospital

Guildford, England, GU2 7XX, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Lincoln County Hospital

Lincoln, England, LN2 5QY, United Kingdom

Location

Charing Cross Hospital

London, England, W6 8RF, United Kingdom

Location

South Manchester University Hospital

Manchester, England, M23 9LT, United Kingdom

Location

Clatterbridge Centre for Oncology NHS Trust

Merseyside, England, CH63 4JY, United Kingdom

Location

Milton Keynes General Hospital

Milton Keynes, England, MK6 5LD, United Kingdom

Location

Derriford Hospital

Plymouth, England, PL6 8DH, United Kingdom

Location

Poole Hospital NHS Trust

Poole Dorset, England, BH15 2JB, United Kingdom

Location

Berkshire Cancer Centre at Royal Berkshire Hospital

Reading, England, RG1 5AN, United Kingdom

Location

Scarborough General Hospital

Scarborough, England, YO12 6QL, United Kingdom

Location

University Hospital of North Tees

Stockton-on-Tees, England, TS19 8PE, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Torbay Hospital

Torquay Devon, England, TQ2 7AA, United Kingdom

Location

Hillingdon Hospital

Uxbridge, England, UB8 3NN, United Kingdom

Location

Worcester Royal Hospital

Worcester, England, WR5 1DD, United Kingdom

Location

Aberdeen Royal Infirmary at NHS Grampian

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Ninewells Hospital

Dundee, Scotland, DD1 9SY, United Kingdom

Location

University of Glasgow

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Ysbyty Gwynedd

Bangor, Wales, LL57 2PW, United Kingdom

Location

University Hospital of Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ

Interventions

Anastrozole; Tamoxifen; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Ronald Kaggwa

  Institute of Cancer Research, United Kingdom

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 10, 2004
• First Posted: February 11, 2004
• Study Start: April 1, 2004
• Primary Completion: September 1, 2017
• Last Updated: February 9, 2009

Record last verified: 2007-10

Locations

GB (29)