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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000028476
Receipt No. 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

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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
Last 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
Email m-sawaki@aichi-cc.jp

Public contact
1st 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/
Email support@csp.or.jp

Sponsor
Institute RESPECT executive committee
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032599

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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