UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the usefulness and safety of goserelin plus tamoxifen as neoadjuvant hormone therapy for premenopausal patients with hormone receptor-positive breast cancer
Acronym	Evaluation of the usefulness and safety of goserelin plus tamoxifen as neoadjuvant hormone therapy for premenopausal patients with hormone receptor-positive breast cancer
Scientific Title	Evaluation of the usefulness and safety of goserelin plus tamoxifen as neoadjuvant hormone therapy for premenopausal patients with hormone receptor-positive breast cancer
Scientific Title:Acronym	Evaluation of the usefulness and safety of goserelin plus tamoxifen as neoadjuvant hormone therapy for premenopausal patients with hormone receptor-positive breast cancer
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The efficacy and safety will be evaluated that goserelin plus tamoxifen is administered to premenopausal patients with hormone receptor-positive invasive breast cancer. The utility of measuring Ki67 for time will be evaluated.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Clinical response
Key secondary outcomes	Pathological response Safety Clinical usefulness Changing of Ki67-score Disease Free Survival

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Neoadjuvant endocrine therapy (goserelin + tamoxifen)
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Premenopausal women with invasive breast cancer who meet the following inclusion criteria. (1) Clinical Stage I-IIB: T1-3N0M0 (2) Patients with a definite diagnosis of invasive breast cancer by core needle biopsy. (3) Patients who meet one of the following criteria for premenopause. (i) Periodic menstruation bleeding. (ii) Patients with amenorrhea in whom LH or FSH is <30 IU/mL and E2 is >10 pg/mL. (4) Patients who has ER positive tumors (Allred total score (TS) is 3 or moreover) in immunohistochemical staining. Not concerned with PgR. (5) HER2 negative by IHC or FISH (6) Patients with bone marrow, renal, and hepatic functions which are adequate to evaluate the safety of the study drug accurately. WBC: >3,000/mm3 Hemoglobin: >9.0 g/dL Platelet count: >10.0 x10000/mm3 AST/ALT: <1.5times the upper limit of the normal range for the medical institution. Serum creatinine: <1.25 times the upper limit of the normal range for the medical institution. (7) ECOG PS is 0-2. (8) Patients who can provide biopsy tissue specimens, isolated tissues, and blood samples
Key exclusion criteria	(1) Patients with previous treatment for the breast cancer. (2) Patients receiving drugs having a potential influence on the status of sex hormones (hormone replacement therapy, raloxifene, etc.). (However, patients after washout for at least 2 months can be enrolled.) (3) Patients with myocardial infarction or congestive heart failure at the past history, or patients who need treatment of ischemic hear disease, arryhythmia or valvular disorder. (4) Patients with active double cancer. (5) Inflammatory breast cancer (6) Synchronous or asynchrous bilateral breast cancer. (7) Allergy for radio-enhancer (8) New test drug (9) Severe psychosomatic disease (10) Patients whom doctors judged inadequate to the enrollment of this study by other reasons.
Target sample size	55

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koichiro Tsugawa, M.D.
Organization	St. Luke's International Hospital
Division name	Department of Breast Surgical Onocology
Zip code
Address	9-1, Akashi-cho, Chuo-ku, Tokyo
TEL	03-3541-5151
Email

Public contact
Name of contact person	1st name Middle name Last name Koichiro Tsugawa, M.D.
Organization	St. Luke's International Hospital
Division name	Department of Breast Surgical Onocology
Zip code
Address	9-1, Akashi-cho, Chuo-ku, Tokyo
TEL	03-3541-5151
Homepage URL
Email	koitsuga@luke.or.jp

Sponsor
Institute	St. Luke's International Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2010 Year 06 Month 03 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	Terminated
Date of protocol fixation	2010 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date	2010 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 06 Month 03 Day
Last modified on	2018 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004482

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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