UMIN-CTR Clinical Trial

Public 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)

Acronym

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

Scientific 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)

Scientific Title:Acronym

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

Low-risk ductal carcinoma in situ (DCIS) of the breast

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Hiroji Iwata

Organization

Aichi Cancer Center Hospital

Division name

Department of Breast Oncology

Zip code

Address

1-1, Kanokoden, Chikusa-ku, Nagoya City, Aichi, 464-8661, Japan

TEL

052-762-6111

Email

hiwata@aichi-cc.jp

Name of contact person

1st name
Middle name
Last name	Chizuo Kanbayashi

Organization

JCOG1505 Coordinating Office

Division name

Department of Breast Oncology, Niigata Cancer Center Hospital

Zip code

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

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

National Cancer Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2017

Year

07

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2017

Year

04

Month

18

Day

Date of IRB

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

Other related information

Last follow-up date 2033/1/20

Registered date

2017

Year

07

Month

20

Day

Last modified on

2017

Year

07

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032260