UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000534 |
|---|---|
| Receipt number | R000000645 |
| 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.2) |
| Date of disclosure of the study information | 2006/12/10 |
| Last modified on | 2024/07/07 09:16:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public 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.2)
Acronym
Prospective study of wide excision and endocrine therapy WithOut
RadioTHerapy (WORTH) for early breast cancer (WORTH trial)(No.2)
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.2)
Scientific Title:Acronym
Prospective study of wide excision and endocrine therapy WithOut
RadioTHerapy (WORTH) for early breast cancer (WORTH trial)(No.2)
Region
| Japan |
Condition
Condition
early breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
In-breast recurrence rate
Key secondary outcomes
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 | Maneuver |
Interventions/Control_1
anastrozole
complete tumor resection
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
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. 50 years old or older at definitive surgery and postmenopausal
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
Key exclusion criteria
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
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shozo |
| Middle name | |
| Last name | Ohsumi |
Organization
National Hospital Organization Shikoku Cancer Center
Division name
Breast Oncology
Zip code
791-0280
Address
160 Kou, Minamiumemotomachi, Matsuyama, Ehime
TEL
089-999-1111
sosumi@shikoku-cc.go.jp
Public contact
Name of contact person
| 1st name | Shozo |
| Middle name | |
| Last name | Ohsumi |
Organization
National Hospital Organization Shikoku Cancer Center
Division name
Breast Oncology
Zip code
791-0280
Address
160 Kou, Minamiumemotomachi, Matsuyama, Ehime
TEL
089-999-1111
Homepage URL
sosumi@shikoku-cc.go.jp
Sponsor or person
Institute
a Grant-in-Aid for research of cancer treatment from the Ministry of Health, Labor and Welfare of Japan (No.21-7-4)
Institute
Department
Personal name
Funding Source
Organization
a Grant-in-Aid for research of cancer treatment from the Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NHO Shikoku Cancer Center
Address
160 Kou, Minami-umemoto-machi, Matsuyama, Japan
Tel
089-999-1111
osumi.shozo.ur@mail.hosop.go.jp
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
| 2006 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
https://doi.org/10.1007/s12282-022-01406-5
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s12282-022-01406-5
Number of participants that the trial has enrolled
198
Results
One hundred and ninety-eight patients were enrolled. The median age at the time of surgery was 66 years. The median tumor size by palpation was 1.4 cm. The median follow-up period for ipsilateral breast tumor recurrence was 88 months.
The 5- and 8-year IBTR-free rates were 98.4% and 92.9%, respectively.
Older patients developed IBTR significantly less frequently than younger patients. PR positivity significantly increased the IBTR-free rate.
Results date posted
| 2024 | Year | 07 | Month | 07 | Day |
Results Delayed
Results Delay Reason
I forgot to report the results.
Date of the first journal publication of results
| 2022 | Year | 09 | Month | 30 | Day |
Baseline Characteristics
One hundred and ninety-eight patients were enrolled in WORTH 2 between December 2006 and November 2011. The median age at the time of surgery was 66 years and ages were unknown in two patients. The median tumor size by palpation was 1.4 cm and the tumor sizes were not known in 18. The median follow-up period for IBTR was 88 months. Anastrozole was used in 167 patients, exemestane in 11, tamoxifen in 15, unknown in 4, and no hormonal agent was used in 1. One hundred and ninety-two patients did not receive adjuvant chemotherapy, whereas adjuvant chemotherapy was administered to three and three lacked information.
Participant flow
The 5- and 8-year IBTR-free rates were 98.4% and 92.9%, respectively. The 5- and 8-year overall survival rates were 98.9% and 96.2%, respectively, and 5- and 8-year distant DRFS rates were 100% and 97.6%, respectively.
We analyzed the effects of age at the time of surgery, tumor size by palpation, and PR status on IBTR-free rates. Older patients developed IBTR significantly less frequently than younger patients (5-year IBTR-free rates: 97.6% for 64 years or younger vs. 99.0% for 65 or older, P = 0.044). There was no difference in IBTR between the large and small tumors (5-year IBTR-free rates: 97.4% for 1.3 cm or smaller vs. 98.9% for 1.4 cm or larger, P = 0.698). PR positivity significantly increased the IBTR-free rate (5-year IBTR-free rates: 99.4% for PR positive vs. 91.4% for PR negative, P = 0.0003).
Adverse events
none
Outcome measures
ipsilateral breast tumor reccurence rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2006 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2006 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2006 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 11 | Month | 30 | Day |
Last modified on
| 2024 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000645
