Unique ID issued by UMIN | UMIN000030558 |
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Receipt number | R000034889 |
Scientific Title | Phase II study on feasibility of sentinel lymph node biopsy for ycN0 patients treated with primary chemotherapy in cT1-3N1M0 breast cancer |
Date of disclosure of the study information | 2018/02/01 |
Last modified on | 2018/11/12 14:53:39 |
Phase II study on feasibility of sentinel lymph node biopsy
for ycN0 patients treated with primary chemotherapy in cT1-3N1M0 breast cancer
SHARE study
Phase II study on feasibility of sentinel lymph node biopsy
for ycN0 patients treated with primary chemotherapy in cT1-3N1M0 breast cancer
SHARE study
Japan |
breast cancer
Breast surgery |
Malignancy
NO
To validate false negative rate of sentinel node biopsy in ycN0 cases after primary chemotherapy for clinically node-positive breast cancer patients
Efficacy
false negative rate of sentinel node biopsy
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Maneuver |
sentinel node biopsy
Not applicable |
75 | years-old | >= |
Female
1) Physical function enough to receive chemotherapy.
2) Unilateral T1-3N1M0 breast cancer by image diagnosis.
3) Invasive cancer proven by histological examination.
4) Lymph node metastases proven with aspiration cytology or core needle biopsy.
5) ycN0 breast cancer after primary chemotherapy.
1) Non-invasive cancer, or T4 and/or M1 breast cancer.
2) Clinical N0 or N2 and more metastases.
3) Women with pregnancy or breast-feeding.
4) Synchronous bilateral breast cancer
5) Cases with other invasive disease during treatment.
240
1st name | |
Middle name | |
Last name | SHIGERU IMOTO |
Kyorin University Hospital
Department of Breast Surgery
6-20-2 Shinkawa Mitaka-shi Tokyo JAPAN 181-8611
0422-47-5511
imoto@ks.kyorin-u.ac.jp
1st name | |
Middle name | |
Last name | SATOMI YANA |
Japanese Society for Sentinel Node Navigation Surgery
Office
35 Shinanomachi Shinjyuku-ku Tokyo JAPAN 160-8582
03-3353-6440
yanas@z7.keio.jp
Japanese Society for Sentinel Node Navigation Surgery
Japanese Society for Sentinel Node Navigation Surgery
Other
NO
2018 | Year | 02 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2017 | Year | 12 | Month | 20 | Day |
2018 | Year | 02 | Month | 01 | Day |
2017 | Year | 12 | Month | 25 | Day |
2018 | Year | 11 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034889
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