UMIN-CTR Clinical Trial

Basic information
Public title	Follow-up survey following the completion of 'A open-label, randomized controlled study of adjuvant therapy with TAP-144-SR (3M) in premenopausal breast cancer patients'
Acronym	Follow-up survey following TAP-144-SR (3M) study
Scientific Title	Follow-up survey following the completion of 'A open-label, randomized controlled study of adjuvant therapy with TAP-144-SR (3M) in premenopausal breast cancer patients'
Scientific Title:Acronym	Follow-up survey following TAP-144-SR (3M) study
Region	Japan

Condition
Condition	Postsurgical of premenopausal breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This follow-up survey, performed following the completion of 'A controlled study of postoperative adjuvant therapy [2-year treatment, over 3-year treatment(up to 5 year)]with TAP-144-SR(3M) in postmenopausal breast cancer patients', will evaluate long-term outcome after 10- year treatment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Disease-Free Survival
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1) The subject has a histologically confirmed primary breast cancer. 2) The subject has either Estrogen Receptor (ER) -positive or Progesterone Receptor (PgR) &#8211; positive primary tumor. 3) The subject has T1~T3, N not required, M0 tumor determined by the TNM classification (UICC, Sixth Edition, 2002,). The number of axillary lymph node involved is not limited. 4) Any operative procedure for breast cancer is acceptable. 5) Status of preoperative treatment and postoperative adjuvant chemotherapy prior to the study enrollment are not required. 6) The subject is able to receive the study drug and Tamoxifen (TAM) within 12 weeks after surgery or after postoperative adjuvant chemotherapy prior to the study enrollment.. 7) The subject has a history of regular menstrual periods within 12 weeks prior to study enrollment, or the subject has FSH of less than 40 mIU/mL and E2 of 10 pg/mL or more measured within 12 weeks prior to study enrollment. 8) The subject has Performance Status (P.S.) of Grade 0 or 1.
Key exclusion criteria	1) The subject has received preoperative hormone therapy prior to breast cancer surgery. 2) The subject has received postoperative adjuvant hormone therapy prior to the study enrollment. 3) The subject has received bilateral oophorectomy and irradiation to bilateral ovaries. 4) The subject has inflammatory breast cancer or bilateral breast cancer. 5) The subject has double cancer or has a history of carcinoma in other organs. 6) The subject is pregnant or breast-feeding, and of child-bearing potential. 7) The subject has past history of hypersensitivity to the study drug component or synthetic LH-RH, LH-RH derivative, and TAM or TAM analogue (antiestrogen). 8) The subject has severe complications.
Target sample size	222

Research contact person
Name of lead principal investigator	1st name Middle name Last name Junichi Kurebayashi
Organization	Kawasaki Medical School
Division name	Department of Breast and Thyroid Surgery
Zip code
Address	Matsusima577, Kurashiki
TEL	086-462-1111
Email	nomail@no

Public contact
Name of contact person	1st name Middle name Last name Junichi Kurebayashi
Organization	Kawasaki Medical School
Division name	Department of Breast and Thyroid Surgery
Zip code
Address	Matsusima577, Kurashiki Okayama, Japan
TEL	086-462-1111
Homepage URL
Email	nomail@no

Sponsor
Institute	Public Health Research Foundation. Comprehensive Support Project for Oncology Research
Institute
Department

Funding Source
Organization	Public Health Research Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	NPO Japan Clinical Research Support Unit
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	北海道がんセンター (北海道) 札幌乳腺外科クリニック (北海道) 福島県立医科大学附属病院 (福島県) 星総合病院 (福島県) 群馬県立がんセンター (群馬県) 群馬大学医学部付属病院 (群馬県) 東海大学医学部付属病院 (神奈川県) 埼玉県立がんセンター (埼玉県) 国際医療福祉大学三田病院 (東京都) 順天堂大学医学部附属順天堂医院 (東京都) 静岡県立総合病院 (静岡県) 名古屋市立大学病院 (愛知県) 大阪大学医学部附属病院 (大阪府) 大阪ブレストクリニック (大阪府) 兵庫県立がんセンター (兵庫県) 川崎医科大学附属病院 (岡山県)

Other administrative information
Date of disclosure of the study information	2011 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 12 Month 03 Day
Date of IRB	2010 Year 12 Month 03 Day
Anticipated trial start date	2013 Year 01 Month 01 Day
Last follow-up date	2020 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective cohort study following phase 4study

Management information
Registered date	2011 Year 07 Month 27 Day
Last modified on	2020 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007157