Unique ID issued by UMIN | UMIN000000966 |
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Receipt number | R000001163 |
Scientific Title | Evaluation of the usefulness of letrozole as hormone therapy for postmenopausal patients with Ductal Carcinoma In Situ (DCIS) |
Date of disclosure of the study information | 2008/01/04 |
Last modified on | 2012/01/10 11:03:40 |
Evaluation of the usefulness of letrozole as hormone therapy for postmenopausal patients with Ductal Carcinoma In Situ (DCIS)
Evaluation of the usefulness of letrozole as hormone therapy for postmenopausal patients with Ductal Carcinoma In Situ (DCIS)
Evaluation of the usefulness of letrozole as hormone therapy for postmenopausal patients with Ductal Carcinoma In Situ (DCIS)
Evaluation of the usefulness of letrozole as hormone therapy for postmenopausal patients with Ductal Carcinoma In Situ (DCIS)
Japan |
Breast cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
YES
The efficacy and safety will be evaluated that letrozole is administered alone to postmenopausal patients with DCIS
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Objective response
Clinical usefulness
Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Endocrine therapy(Letrozole)
Not applicable |
Not applicable |
Female
Postmenopausal women with DCIS who meet the following inclusion criteria.
(1) Patients with a definite diagnosis of DCIS by core needle biopsy.
To exclude the possibility of invasive carcinoma, it will be confirmed by ultrasound that no lumps are formed.
(2) Patients who has ER positive tumors (Allred total score (TS) 3) in immunohistochemical staining.
Not concerned with PgR.
(3) Patients who meet one of the following criteria for postmenopause.
(i) Patients aged 55 years and moreover, at 1 year after the last menstruation.
(ii) Patients aged <55 years with amenorrhea (spontaneous, drug-induced, or hysterectomy-induced menopause) in whom LH or FSH is 30 IU/mL or E2 is <20 pg/mL.
(iii) Patients who underwent bilateral oophorectomy.
(iv) Patients who have had amenorrhea for 3 months because of loss of ovarian function due to radiotherapy.
(5) Patients without previous treatment for DCIS.
(6) Patients with bone marrow, renal, and hepatic functions which are adequate to evaluate the safety of the study drug accurately.
WBC: >3,500/mm3
Hemoglobin: >11.0 g/dL
Platelet count: >10.0 x100000/mm3
Serum creatinine: <1.5 times the upper limit of the normal range for the medical institution
Total bilirubin: <1.5 times the upper limit of the normal range for the medical institution
AST/ALT: <2.5 times the upper limit of the normal range for the medical institution.
(7)Patients with performance status (ECOG Performance Status: PS) 0-1.
(8)Patients who can provide biopsy tissue specimens, isolated tissues, and blood samples for investigation.
(9)Patients from whom written informed consent to participation in the study has been obtained.
(1)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.)
(2)Patients with bilateral DCIS.
(3)Patients within 30 days after completion of treatment with the investigational drugs.
20
1st name | |
Middle name | |
Last name | Seigo Nakamura |
St. Luke's International Hospital
Breast Surgical Oncology
9-1,Akashi-cho,Chuo-ku,Tokyo
03-3541-5151
1st name | |
Middle name | |
Last name | Takashi Kuwayama |
St. Luke's International Hospital
Breast Surgical Oncology
9-1,Akashi-cho,Chuo-ku,Tokyo
03-3541-5151
kuwayama-bc@umin.ac.jp
St. Luke's International Hospital
None
Self funding
NO
聖路加国際病院
2008 | Year | 01 | Month | 04 | Day |
Unpublished
No longer recruiting
2006 | Year | 07 | Month | 07 | Day |
2006 | Year | 08 | Month | 01 | Day |
2008 | Year | 12 | Month | 01 | Day |
2008 | Year | 01 | Month | 04 | Day |
2012 | Year | 01 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001163
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