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
40 Years
70 Years
Female
Breast Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Local tumor control (invasive and in situ local recurrence)
Safety Issue:
No
Principal Investigator
Ronald Kaggwa
Investigator Affiliation:
Institute of Cancer Research, United Kingdom
Authority:
United States: Federal Government
Study ID:
CDR0000349580
NCT ID:
NCT00077168
Start Date:
April 2004
Completion Date:
Related Keywords:
- Breast Cancer
- ductal breast carcinoma in situ
- breast cancer in situ
- Breast Neoplasms
- Carcinoma
- Carcinoma in Situ
- Carcinoma, Intraductal, Noninfiltrating
- Carcinoma, Ductal, Breast
- Carcinoma, Ductal
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