Single-arm confirmatory trial of endocrine therapy alone for estrogen receptor-positive, low-risk ductal carcinoma in situ of the breast (JCOG1505, LORETTA trial)

UMIN ID: UMIN000028298

Registered date:20/07/2017

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Low-risk ductal carcinoma in situ (DCIS) of the breast
• Date of first enrollment: 2017/07/20
• Target sample size: 340
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): A: Tamoxifen 20 mg daily for 5 years

Outcome(s)

• Primary Outcome: 5-year cumulative incidence of invasive-ipsilateral breast tumor (I-IBT)
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude 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

Related Information

• Primary Sponsor: Japan Clinical Oncology Group (JCOG)
• Source(s) of Monetary Support: National Cancer Center