Unique ID issued by UMIN | UMIN000000535 |
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Receipt number | R000000648 |
Scientific Title | Prospective study of wide excision and endocrine therapy WithOut RadioTHerapy (WORTH) for node-negative estrogen receptor positive early breast cancer with histologically negative margins (WORTH trial)(No.3) |
Date of disclosure of the study information | 2006/12/10 |
Last modified on | 2019/12/16 20:33:01 |
Prospective study of wide excision and endocrine therapy WithOut
RadioTHerapy (WORTH) for node-negative estrogen receptor positive early
breast cancer with histologically negative margins (WORTH trial)(No.3)
Prospective study of wide excision and endocrine therapy WithOut
RadioTHerapy (WORTH) for early breast cancer (WORTH trial)(No.3)
Prospective study of wide excision and endocrine therapy WithOut
RadioTHerapy (WORTH) for node-negative estrogen receptor positive early
breast cancer with histologically negative margins (WORTH trial)(No.3)
Prospective study of wide excision and endocrine therapy WithOut
RadioTHerapy (WORTH) for early breast cancer (WORTH trial)(No.3)
Japan |
early breast cancer
Breast surgery | Radiology |
Malignancy
NO
Our aim of this trial is to determine in-breast recurrence rate in the patients who experience breast-conserving surgery, do not have all the factors which were shown to be risk factors for in-breast recurrence after breast-conserving treatment including radiotherapy in the retrospective study, and do not receive radiotherapy.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
In-breast recurrence rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Maneuver |
tamoxifen
complete tumor resection
40 | years-old | <= |
49 | years-old | >= |
Female
1. tumor size is 3 cm or smaller on palpation
2. pathologically axillary node negative (or no metastasis in sentinel node(s) if only sentinel node biopsy was done) and no distant metastasis or a case of ductal carcinoma in situ
3. No preoperative treatments including chemotherapy, endocrine therapy and radiotherapy
4. 40 to 49 years old at definitive surgery
5. a tumor was resected with wide local excision and the pathological margins were negative (tumor cells must be absent in the zone of 5mm or more from the margins)
6. no pathological findings of lymph vessel invasion
7. estrogen receptor positive in the primary tumor
8. within 8 weeks after the definitive surgery
9. a written informed consent was obtained
1. multicentricity of the tumor is suspected
2. past history of breast cancer or synchronous bilateral breast cancer
3. trastuzumab treatment is planned
4. the patient has mental disorder
5. any reason the physician believes that the patient is not appropriate to participate in the study
200
1st name | Shozo |
Middle name | |
Last name | Shozo |
National Hospital Organization Shikoku Cancer Center
Breast Oncology
791-0280
160 Kou, Minamiumemotomachi, Matsuyama, Ehime
089-999-1111
sosumi@shikoku-cc.go.jp
1st name | Shozo |
Middle name | |
Last name | Ohsumi |
National Hospital Organization Shikoku Cancer Center
Breast Oncology
791-0280
160 Kou, Minamiumemotomachi, Matsuyama, Ehime
089-999-1111
sosumi@shikoku-cc.go.jp
a Grant-in-Aid for research of cancer treatment from the Ministry of Health, Labor and Welfare of Japan (No.17-7)
a Grant-in-Aid for research of cancer treatment from the Ministry of Health, Labor and Welfare of Japan (No.21-7-4)
Japanese Governmental office
Japan
NHO Shikoku Cancer Center
160 Kou, Minami-umemoto-machi, Matsuyama, Japan
089-999-1111
089-999-1100
NO
四国がんセンター(愛媛県)、大阪府立成人病センター(大阪府)、熊本市民病院(熊本県)、大阪医療センター(大阪府)、国立がん研究センター中央病院(東京都)
2006 | Year | 12 | Month | 10 | Day |
Unpublished
No longer recruiting
2006 | Year | 11 | Month | 30 | Day |
2006 | Year | 12 | Month | 01 | Day |
2022 | Year | 03 | Month | 01 | Day |
2006 | Year | 12 | Month | 02 | Day |
2019 | Year | 12 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000648
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