UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cohort Study to Evaluate the Efficacy and Safety of Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients
Title of the study (Brief title)	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	Masataka Sawaki
Organization	Aichi Cancer Center Hospital
Division name	Department of Breast Oncology
Address	1-1 Kanokoden Chikusa-ku, Nagoya, 464-8681 Japan
TEL	052-762-6111
Email	m-sawaki@aichi-cc.jp

Public contact
Name of contact person	Akira Yamao
Organization	Public Health Research Foundation
Division name	Comprehensive Support Project for Clinical Research
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2009 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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