UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007353 |
|---|---|
| Receipt number | R000008564 |
| Scientific Title | A phase II neoadjuvant trial of concurrent trastuzumab and aromatase inhibitor in postmenopausal women with HER2-positive and hormone receptor-positive breast cancer. |
| Date of disclosure of the study information | 2012/02/22 |
| Last modified on | 2024/03/21 11:18:39 |
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Basic information
Public title
A phase II neoadjuvant trial of concurrent trastuzumab and aromatase inhibitor in postmenopausal women with HER2-positive and hormone receptor-positive breast cancer.
Acronym
A phase II neoadjuvant trial of concurrent trastuzumab and aromatase inhibitor in postmenopausal women with HER2-positive and hormone receptor-positive breast cancer.
Scientific Title
A phase II neoadjuvant trial of concurrent trastuzumab and aromatase inhibitor in postmenopausal women with HER2-positive and hormone receptor-positive breast cancer.
Scientific Title:Acronym
A phase II neoadjuvant trial of concurrent trastuzumab and aromatase inhibitor in postmenopausal women with HER2-positive and hormone receptor-positive breast cancer.
Region
| Japan |
Condition
Condition
Postmenopausal women with HER2-positive and hormone receptor-positive breast cancer.
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy and safety of trastuzumab with aromatase inhibitor as neoadjuvant therapy for HER2-positive and hormone receptor-positve breast cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
clinical response rate, tumor reduction rate
Key secondary outcomes
pathological CR rate, adverse event, breast conserving rate, relapse free survival, Ki-67 index changes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Letrozole is given daily at a dose of 2.5mg concomitantly with trastuzumab for 6 months before surgery.
Trastuzumab is given with a loading dose of 8 mg/kg; subsequent doses are 6 mg/kg every three weeks for 8 cycles.
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
| 90 | years-old | > |
Gender
Female
Key inclusion criteria
1. Histologically confirmed invasive breast cancer
2. ER and or PgR-positive, HER2-positive
3. Measurable disease
4. Stage I , II or III
5. Performance status 0 or 1
6. Untreated breast cancer
7. Meet the cirteria of baseline labolatory parameters as below.
1) WBC 3500/mm3 or more, 10000/mm3 or less, Plt 100,000/mm3 or more, Hb 10g/dl or more
2) T.Bil 1mg/dl or less, GOT 60 IU/L or less, GPT 60 IU/L or less
8. Written informed consent
9. Confirmed menopausal status. In case of prior hysterectomy, parameters of E2, LH and FSH are consistent with those of postmenopause status.
Key exclusion criteria
1. Inflammatory breast cancer
2. Other active malignancies
3. History of cardiac infarction, valvular diseases of the heart and severe cardiac disfunction
4. Other medical conditions that could limit a patient's ability to undertake study therapy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Jinno |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
35 Shinanomachi Shinjuku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Jinno |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
35 Shinanomachi Shinjuku, Tokyo, Japan
TEL
Homepage URL
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
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
稲城市立病院(Inagi Municipal HP) 川崎市立井田病院(Kawasaki Ida HP) 北里大学北里研究所病院(Kitasato Institute HP) 立川病院(Tachikawa HP) けいゆう病院(Keiyu HP) 公立福生病院(Fussa HP) 東京医療センター (National Tokyo Medical center) 佐野厚生総合病院(Sano Kousei HP) 済生会横浜市東部病院(Saiseikai Yokohamashi Tobu HP) 埼玉社会保険病院(Saitama Social Insurance HP) 東京歯科大学市川総合病院(Tokyo Dental College Ichikawa HP)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 22 | 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 | 02 | Month | 05 | Day |
Date of IRB
| 2011 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 02 | 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 | 02 | Month | 22 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008564
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