Low-risk ductal carcinoma in situ (DCIS) of the breast
Conditions
Interventions
A: Tamoxifen 20 mg daily for 5 years
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. All of the following conditions are fulfilled by biopsy (core needle biopsy or vacuum-assisted biopsy) from the breast primary site within 84 days before the registration: i) Histologically proven DCIS, ii) Must be classified as low (NG1) or intermediate (NG2) nuclear grade, iii) No comedo necrosis, iv) High estrogen receptor positive is defined in immunohistochemical staining, v) HER2-negative 2. All of the following conditions are fulfilled by examination within 84 days before the registration: i) No palpable mass, ii) The presence of calcification in MMG, iii) No mammographic mass, iv) No invasive cancer findings in US and MRI, v) The tumor diameters measured by MMG, US and MRI are all 2.5 cm or less, vi) No multiple lesions in either ipsilateral breast or contralateral breast, vii) No regional lymph node metastasis in MMG, US and MRI, viii) No distant metastasis in image examination or clinical findings 3. ECOG performance status (PS) of 0 or 1 4. No history of both non-invasive and invasive breast cancer 5. BRCA positivity has not been confirmed (BRCA test is not mandatory) 6. Sufficient organ functions: i) WBC >= 2,000/mm3 ii) ANC >= 1,000/mm3 iii) Hemoglobin >= 8.0 g/dL iv) Platelet >= 50,000/mm3 v) AST =< 100 U/L vi) ALT =< 100 U/L vii) T.Bil =< 1.5 mg/dL viii) Creatinine =< 1.5 mg/dL 7. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Simultaneous or metachronous (within 5 years) double cancers 2. Infectious disease with systemic therapy indicated 3. Body temperature of 38 or more degrees Celsius 4. Pregnancy, possible pregnancy, within 28 days after delivery or breast-feeding 5. Psychiatric diseases 6. Continuous systemic steroid or immune-suppressive drug therapy 7. Poorly controlled diabetes mellitus in spite of continuous use of insulin 8. Poorly controlled hypertension 9. Unstable angina pectoris, or history of myocardial infarction within six months 10. Interstitial pneumonitis, pulmonary fibrosis or severe pulmonary emphysema 11. History of uterine cancer 12. History of thrombosis, embolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year cumulative incidence of invasive-ipsilateral breast tumor (I-IBT) | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year cumulative incidence of I-IBT >1.0 cm, I-IBT-free survival, Overall survival, Breast cancer specific survival, Contralateral invasive breast cancer free survival, Proportion of ipsilateral surgery, Time to surgery for ipsilateral breast cancer, Time-to-treatment-failure , Adverse events, Serious adverse events | — |
Countries
Japan
Contacts
Public ContactChizuo Kanbayashi
JCOG1505 Coordinating Office Department of Breast Oncology, Niigata Cancer Center Hospital
Outcome results
None listed