Status:
UNKNOWN
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
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Conditions:
Breast Cancer
Eligibility:
FEMALE
40-70 years
Phase:
PHASE2
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 s...
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 i...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT00077168
Start Date
April 1 2004
Last Update
February 9 2009
Active Locations (29)
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1
Frenchay Hospital at North Bristol NHS Trust
Bristol, England, United Kingdom, BS16 1LE
2
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
3
Broomfield Hospital
Broomefield, England, United Kingdom, CM1 7ET
4
Chelmsford and Essex Centre
Chelmsford, England, United Kingdom, CM2 0QH