UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006049 |
|---|---|
| Receipt number | R000007158 |
| Scientific Title | Prospective study of neoadjuvant goserelin, anastrozole and radiotherapy for hormone-responsive premenopausal breast cancer |
| Date of disclosure of the study information | 2011/07/27 |
| Last modified on | 2017/05/08 10:52:26 |
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Basic information
Public title
Prospective study of neoadjuvant goserelin, anastrozole and radiotherapy for hormone-responsive premenopausal breast cancer
Acronym
Neoadjuvant goserelin, anastrozole and radiotherapy
Scientific Title
Prospective study of neoadjuvant goserelin, anastrozole and radiotherapy for hormone-responsive premenopausal breast cancer
Scientific Title:Acronym
Neoadjuvant goserelin, anastrozole and radiotherapy
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 assess the usefulness and feasibility of neoadjuvant goserelin, anastrozole and radiotherapy for hormone-responsive premenopausal breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical response 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
Patients will receive anastrozole 1mg daily and goserelin 3.6mg monthly for 24 weeks and receive radiotherapy (50Gy / 25 fr) at 13 weeks from the start of anastrozole. Patients will receive surgery at 24 weeks.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Premenopausal patients with biopsy-proven invasive breast cancer
2) TNM classification: T (2-5 cm), N0, M0
3) ER-positive tumor (10% or more positively staining by immunohistochemistry)
4) PS (ECOG): 0 or 1
5) Normal bone marrow, liver and renal function
6) Patients who have never received any treatment for breast cancer
7) Written informed consent is obtained
Key exclusion criteria
1) past history of any invasive malignancy within the previous 5 years
2) past history of breast cancer or synchronous bilateral breast cancer
3) past history of radiotherapy for ipsilateral breast
4) Suspicious of allergy for radiotherapy
5) Past use of LH-RH agonist or aromatase inhibitors
6) Suspicious of allergy for LH-RH agonist or aromatase inhibitors
7) Patients who had received or are receiving any steroids, estrogens or selective estrogen receptor modulators
8) Any reason the physician believes that the patient is not appropriate to participate in the study
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Ishitobi |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL
06-6972-1181
isitobi-ma@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Ishitobi |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL
06-6972-1181
Homepage URL
isitobi-ma@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 07 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 27 | Day |
Last modified on
| 2017 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007158
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
