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:
Institute of Cancer Research, United Kingdom
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
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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) |
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
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 | |
| 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
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, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Carcinoma, Ductal Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary Adjuvants, Immunologic |
Tamoxifen Anastrozole Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Estrogen Antagonists Aromatase Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013