UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Single-arm confirmatory trial of endocrine therapy alone for estrogen receptor-positive, low-risk ductal carcinoma in situ of the breast (JCOG1505, LORETTA trial)
Title of the study (Brief title)	Single-arm confirmatory trial of endocrine therapy alone for estrogen receptor-positive, low-risk ductal carcinoma in situ of the breast (JCOG1505, LORETTA trial)
Region	Japan

Condition
Condition	Low-risk ductal carcinoma in situ (DCIS) of the breast
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm whether endocrine therapy alone for estrogen receptor-positive low-risk DCIS is safe and effective compared with the current standard treatment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	5-year cumulative incidence of invasive-ipsilateral breast tumor (I-IBT)
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A: Tamoxifen 20 mg daily for 5 years
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	75 years-old >=
Gender	Female
Key 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
Key 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
Target sample size	340

Research contact person
Name of lead principal investigator	Hiroji Iwata
Organization	Aichi Cancer Center Hospital
Division name	Department of Breast Oncology
Address	1-1, Kanokoden, Chikusa-ku, Nagoya City, Aichi, 464-8661, Japan
TEL	052-762-6111
Email	hiwata@aichi-cc.jp

Public contact
Name of contact person	Chizuo Kanbayashi
Organization	JCOG1505 Coordinating Office
Division name	Department of Breast Oncology, Niigata Cancer Center Hospital
Address	2-15-3, Kawagishicho, Chuo-ku, Niigata City, Niigata, 951-8566, Japan
TEL	025-266-5111
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization	National Cancer Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

国立病院機構北海道がんセンター（北海道） 岩手医科大学（岩手県） 東北大学病院（宮城県） 筑波大学医学医療系（茨城県） 自治医科大学（栃木県） 群馬県立がんセンター（群馬県） 埼玉県立がんセンター（埼玉県） 国立がん研究センター東病院（千葉県） 千葉県がんセンター（千葉県） 国立がん研究センター中央病院（東京都） がん・感染症センター都立駒込病院（東京都） 国立病院機構東京医療センター（東京都） 昭和大学病院（東京都） がん研究会有明病院（東京都） 虎の門病院（東京都） 聖路加国際病院（東京都） 東海大学医学部（神奈川県） 聖マリアンナ医科大学（神奈川県） 北里大学医学部（神奈川県） 新潟県立がんセンター新潟病院（新潟県） 静岡県立総合病院（静岡県） 静岡県立静岡がんセンター（静岡県） 愛知県がんセンター中央病院（愛知県） 国立病院機構名古屋医療センター（愛知県） 名古屋市立大学病院（愛知県） 近畿大学医学部（大阪府） 大阪国際がんセンター（大阪府） 国立病院機構大阪医療センター（大阪府） 岡山大学病院（岡山県） 国立病院機構呉医療センター・中国がんセンター（広島県） 広島大学病院（広島県） 広島市立広島市民病院（広島県） 国立病院機構福山医療センター（広島県） 広島市立安佐市民病院（広島県） 国立病院機構四国がんセンター（愛媛県） 国立病院機構九州がんセンター（福岡県） 北九州市立医療センター（福岡県） 国立病院機構長崎医療センター（長崎県） 熊本大学医学部（熊本県） 博愛会相良病院（鹿児島県）

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 20 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 04 Month 18 Day
Anticipated trial start date	2017 Year 07 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Last follow-up date 2033/1/20

Management information
Registered date	2017 Year 07 Month 20 Day
Last modified on	2017 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032260