UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008416 |
|---|---|
| Receipt number | R000009898 |
| Scientific Title | Randomized phase II study of neoadjuvant chemotherapy with or without letrozole for postmenopausal ER-positive/HER2-negative breast cancers |
| Date of disclosure of the study information | 2012/07/16 |
| Last modified on | 2020/03/15 14:44:49 |
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Basic information
Public title
Randomized phase II study of neoadjuvant chemotherapy with or without letrozole for postmenopausal ER-positive/HER2-negative breast cancers
Acronym
KBCOG 10
Scientific Title
Randomized phase II study of neoadjuvant chemotherapy with or without letrozole for postmenopausal ER-positive/HER2-negative breast cancers
Scientific Title:Acronym
KBCOG 10
Region
| Japan |
Condition
Condition
Postmenopausal breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate efficacies of neoajuvant chemotherapy with letrozole on patients with psotmenopausal ER-positive and HER2-negative.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall Response Rate
Key secondary outcomes
Pathological complete response rate, Breast conserving rate, Safety, Disease-free survival, Overall survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
letrozole, 25mg/day, 24 weeks
Interventions/Control_2
without letrozole
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Stage2A, 2B, 3A, 3B breast cancer
2) Histologically or cytologically confirmed breast cancer
3) Postmenopausal women
4) ER-positive (10% or more cancer cells were positive)
5) HER2-negatie (IHC score 0, 1+, or IHC score 2+ and FISH-negative)
6) 75 years old or less
7) Performance status 0 or 1
8) Breast cancers with evaluable lesion
9) Sufficient organ function meeting following criteria:
(1) Leukocyte > 3000 mm3 or Neutrophil >1500 mm3
(2) Hemoglobin >9.0g/dL
(3) Platelet >100000 mm3
(4) AST (GOT) and ALT(GPT) < 2.5 x upper limit of normal (ULN)
(5) Serum total bilirubin <1.5 mg/dL
(6) Serum creatinine <1.5 mg/dL
(7) Normal electrocardiogram
(8) LVEF is >55% measured by echocardiography or MUGA scan
10) No finding of pneumonitis by Chest CT or X-ray
11) MRI or CT of the breast must be done pre- and post-chemotherapy
12) No prior treatment for breast cancers
13) Signed written informed consent
Key exclusion criteria
1) Inflammatory breast cancer
2) Bilateral breast cancers without DCIS or ICIS
3) With multiple cancers diagnosed with 5 years
4) With uncontrollable hypertension, angina pectoris, congestive heart failure
5) With severe complication including infection or uncontrolled diabetes mellitus
6) With viral hepatitis (HBs antigen- or HCV antibody-positive)
7) Patients treated with endocrine therapy
8) Infection or possible infection associated with clinical symptoms such as fever
9) With severe edema
10) With severe mental disorder
11) Cases who physician judged improper to entry this trial
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Miyoshi |
Organization
Hyogo College of Medicine
Division name
Breast and Endocrine Surgery
Zip code
663-8501
Address
Mukogawa 1-1, Nishinomiya, Hyogo 663-8501
TEL
0798-45-6374
ymiyoshi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yasuo |
| Middle name | |
| Last name | Miyoshi |
Organization
Kobe Breast Cancer Oncology Group
Division name
Hyogo College of medicine
Zip code
663-8501
Address
Mukogawa 1-1, Nishinomiya, Hyogo 663-8501
TEL
0798-45-6374
Homepage URL
ymiyoshi@hyo-med.ac.jp
Sponsor or person
Institute
Kobe Breast Cancer Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Kobe Breast Cancer Oncology Group
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
Institutional Review Board of Hyogo College of Medicine
Address
Mukogawa 1-1, Nishinomiya City
Tel
0798456374
rinri@hyo-med.ac.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
| 2012 | Year | 07 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 12 | Day |
Last modified on
| 2020 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009898
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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