Unique ID issued by UMIN | UMIN000035291 |
---|---|
Receipt number | R000040204 |
Scientific Title | Twenty-Four Weeks of Neoadjuvant Exemestane for Postmenopausal Women with Estrogen Receptor Positive Breast Cancer (SBCCSG 23) |
Date of disclosure of the study information | 2018/12/19 |
Last modified on | 2020/07/20 17:24:57 |
Twenty-Four Weeks of Neoadjuvant Exemestane for Postmenopausal Women with Estrogen Receptor Positive Breast Cancer (SBCCSG 23)
Twenty-Four Weeks of Neoadjuvant Exemestane for Postmenopausal Women with Estrogen Receptor Positive Breast Cancer (SBCCSG 23)
Twenty-Four Weeks of Neoadjuvant Exemestane for Postmenopausal Women with Estrogen Receptor Positive Breast Cancer (SBCCSG 23)
Twenty-Four Weeks of Neoadjuvant Exemestane for Postmenopausal Women with Estrogen Receptor Positive Breast Cancer (SBCCSG 23)
Japan |
breast cancer
Breast surgery |
Malignancy
NO
To investigate the changes of indication for adjuvant chemotherapy in patients who underwent neoadjuvant endocrine therapy (NAE) and to evaluate the role of NAE for postmenopausal women with ER-positive breast cancer
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
To investigate the changes of primary indication for adjuvant chemotherapy in patients who underwent neoadjuvant exemestane
1.objective responce rate 2.tumor size 3.method of surgery 4.rate of positive surgical margin 5.PEPI score 6.pathological response 7.PgR 8.DFS 9.OS 10.safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
24 weeks of neoadjuvant exemestane 25mg/day
Not applicable |
Not applicable |
Female
postmenopausal ER positive and HER2 nagative, cStage 2A,2B,3A breast cancer patients
patients already treated for breast cancer
patients with a past history of breast cancer or with double cancer
patients who should be treated by any other therapy
60
1st name | Hiroshi |
Middle name | |
Last name | Matsumoto |
Saitama Cancer Center
Division of breast surgery
362-0806
780 Komuro, Ina-machi, Kitaadachi-gun, Saitama 362-0806, Japan
048-722-1111
hiromatsu@cancer-c.pref.saitama.jp
1st name | Jun |
Middle name | |
Last name | Ninomiya |
Saitama Breast Cancer Clinical Study Group(SBCCSG)
executive office(Ninomiya Hospital)
340-0056
2-22-23 Shinsakae, Souka city, Saitama 330-0843, Japan
048-941-2223
http://www.sbccsg.org/
jninomiya@grape.plala.or.jp
Saitama Breast Cancer Care Support Group(SBCCSG)
self funding
Other
Saitama cancer center Institutional review board
780 Komuro, Ina-machi, Kitaadachi-gun, Saitama 362-0806, Japan
048-722-1111
sccctmo01@cancer-c.pref.saitama.jp
NO
2018 | Year | 12 | Month | 19 | Day |
Unpublished
No longer recruiting
2011 | Year | 06 | Month | 01 | Day |
2011 | Year | 10 | Month | 25 | Day |
2018 | Year | 12 | Month | 17 | Day |
2020 | Year | 07 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040204
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |