UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028476 |
|---|---|
| Receipt number | R000032599 |
| Scientific Title | Cohort Study to Evaluate the Efficacy and Safety of Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2019/01/09 16:41:49 |
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Basic information
Public title
Cohort Study to Evaluate the Efficacy and Safety of Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients
Acronym
Cohort Study accompanying with N-SAS BC07/RESPECT
Scientific Title
Cohort Study to Evaluate the Efficacy and Safety of Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients
Scientific Title:Acronym
Cohort Study accompanying with N-SAS BC07/RESPECT
Region
| Japan |
Condition
Condition
HER2 positive primary breast cancer in elderly
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate clinical positioning between trastuzumab (Herceptin) monotherapy (H group) and combination therapy of trastuzumab and chemotherapy (H+CT group) based on a prospective cohort study randomized controlled trial in women over 70 years with human epidermal growth factor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Disease-Free Survival (DFS)
Key secondary outcomes
Overall Survival (OS), Relapse-free Survival (RFS), Safety, HRQOL, CGA
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 70 | years-old | <= |
Age-upper limit
| 81 | years-old | > |
Gender
Female
Key inclusion criteria
1. Histologically diagnosed as invasive breast cancer and received curative operation for primary breast cancer.
2. Stage: 1 (tumor size [pT] > 0.5 cm), 2A, 2B or 3A/ M0
3. Female between 69 and 81 years old
4. Primary region is HER 2 positive: either 3+ overexpression by IHC or positive by FISH
5. Baseline left ventricular ejection fraction (LVEF) is >=55% measured by echocardiography or MUGA scan within 4 weeks before registration.
6. PS: 0-1 (ECOG)
7. Sufficient organ function meeting following criteria within 4 weeks before registration:
(1) Leukocyte >=2500 mm3
(2) Neutrophil >=1500 mm3
(3) Platelet >=100 000 mm3
(4) Serum total bilirubin >=2.0 x upper limit of normal (ULN)
(5) ALT (GPT) or AST (GOT) >=2.5 x ULN
(6) Serum creatinine >=2.0 x ULN
(7) ALP >=2.5 x ULN
8. No previous endocrine therapy or chemotherapy for breast cancer
9. Signed written informed consent
10.Patient who refused to participate in the N-SAS BC 07 randomized control study
Key exclusion criteria
1. Active multiple primary cancer (synchronous multiple primary cancer and invasive cancer of other organs)
2. Postoperative histological axillary lymph node metastasis >=4
3. Axillary lymph node is not histologically evaluated
4. Histologically confirmed positive margin in breast conservation surgery (evaluation of margin status is based on policy of site)
5. History of drug-related allergy which could hinder planned treatment
6. Any history or complication of following cardiac disorders
- History of congestive heart failure, cardiac infarction
- Complication requires treatment such as: ischemic cardiac disorder, arrhythmia, valvular heart disease
7. Poorly controlled hypertension (ex. Systolic arterial pressure >=180 mmHg or diastolic blood pressure >=100 mmHg)
8. Poorly controlled diabetes
9. Continuous visit to a medial institution is considered difficult due to deterioration of activity of daily living (ADL)
10. Difficult to participate in the trial because of psychiatric disorder or psychiatric symptoms
11. Ineligible to the trial based on decision of an investigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masataka Sawaki |
Organization
Aichi Cancer Center Hospital
Division name
Department of Breast Oncology
Zip code
Address
1-1 Kanokoden Chikusa-ku, Nagoya, 464-8681 Japan
TEL
052-762-6111
m-sawaki@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Yamao |
Organization
Public Health Research Foundation
Division name
Comprehensive Support Project for Clinical Research
Zip code
Address
1-1-7, Nishiwaseda, Shinjyuku-ku, Tokyo, 169-0051 Japan
TEL
03-5287-2633
Homepage URL
http://www.csp.or.jp/
support@csp.or.jp
Sponsor or person
Institute
RESPECT executive committee
Institute
Department
Personal name
Funding Source
Organization
Public Health Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2017 | Year | 08 | Month | 01 | 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
Main results already published
Date of protocol fixation
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All patients who has given consent to participate in the study during from Oct. 2009 to Oct. 2014.
This study is observational cohort study without any intervention.
This study applies dataset from UMIN000002349 as external control for statistical analysis.
Management information
Registered date
| 2017 | Year | 08 | Month | 01 | Day |
Last modified on
| 2019 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032599
| 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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| Registered date | File name |
