| Phase II Randomized Study of Adjuvant Radiotherapy Versus Observation 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
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate 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
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II | Treatment | Closed | 40 to 70 | ICR-DCIS-II
EU-20341, NCT00077168 |
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.
Entry 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
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy - See Disease Characteristics
- No prior tamoxifen or raloxifene use for more than 3 months in duration
Radiotherapy Surgery - See Disease Characteristics
- No prior mastectomy
Other - No concurrent anticoagulants
Patient Characteristics:
Sex Menopausal status -
Premenopausal, perimenopausal, or postmenopausal
Performance status Life expectancy Hematopoietic Hepatic Renal 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
Expected Enrollment 2000A total of 2,000 patients (1,000 per treatment arm) will be accrued for this study within 5 years. Outcomes Primary Outcome(s)Local tumor control (invasive and in situ local recurrence)
Secondary Outcome(s)Mastectomy rate
Pattern of relapse in the breast
Contralateral primary
Breast cancer metastases
Mortality
Quality of life
Molecular markers that predict ipsilateral tumor recurrence
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
Trial Contact Information
Trial Lead Organizations Institute of Cancer Research - Sutton  | | | | Ronald Kaggwa, Study coordinator | | | |
| Registry Information | | | 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 | | | Trial Start Date | | 2004-04-01 | | | Trial Completion Date | | 2017-09-30 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00077168 | | | Date Submitted to PDQ | | 2003-12-11 | | | Information Last Verified | | 2007-10-14 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
