UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006050 |
|---|---|
| Receipt number | R000007157 |
| 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' |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2020/03/13 11:28:06 |
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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) – 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
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
nomail@no
Sponsor or person
Institute
Public Health Research Foundation.
Comprehensive Support Project for Oncology Research
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007157
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