UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the usefulness of letrozole as neoadjuvant hormone therapy for postmenopausal patients with hormone receptor-positive breast cancer
Title of the study (Brief title)	Evaluation of the usefulness of letrozole as neoadjuvant hormone therapy for postmenopausal 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 letrozole is administered to postmenopausal 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	Endocrine therapy (letrozole)
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	Postmenopausal women with invasive breast cancer who meet the following inclusion criteria. (1) Patients with a definite diagnosis of invasive breast cancer by core needle biopsy. (2) Clinical Stage I-IIIA: T1-3N0-1M0 (excluded N2) (3) Patients who has ER positive tumors (Allred total score (TS) is 3 or moreover) in immunohistochemical staining. Not concerned with PgR. (4) HER2 negative by IHC or FISH (5) Patients who meet one of the following criteria for postmenopause. (i) Patients aged 60 years and moreover.(ii) Patients aged less than 60 years old with amenorrhea (spontaneous, drug-induced, or hysterectomy-induced menopause) in whom LH or FSH is more than 30 IU/mL or E2 is <20 pg/mL. (iii) Patients who underwent bilateral oophorectomy. (6) Subjects must meet all of the following criteria for inclusion in the study. i) Serum creatinine: <1.5 times the upper limit of the normal range for the medical institution. ii) AST/ALT: <2.5 times the upper limit of the normal range for the medical institution. (7) ECOG PS is 0-1. (8) Patients who can provide biopsy tissue specimens, isolated tissues, and blood samples for investigation. (9) Patients from written informed consent to participation in the study has been obtained.
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) Synchronous or asynchrous bilateral breast cancer. (4) Patients with active double cancer. (5) 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. (6) Patients within 30 days after completion of treatment with the investigational drugs. (7) Patients whom doctors judged inadequate to the enrollment of this study by other reasons.
Target sample size	60

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

Public contact
Name of contact person	Koichiro Tsugawa
Organization	St. Luke's International Hospital
Division name	Department of Breast Surgical Oncology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 03 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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=R000004481