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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000651
Receipt No. R000000780
Scientific Title Randomized Phase II Study of Neoadjuvant Chemotherapy and Trastuzumab (Herceptin) for Operable Breast Cancer with Overexpression of HER2
Date of disclosure of the study information 2007/03/23
Last modified on 2012/03/26

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Basic information
Public title Randomized Phase II Study of Neoadjuvant Chemotherapy and Trastuzumab (Herceptin) for Operable Breast Cancer with Overexpression of HER2
Acronym Phase II study of Neoadjuvant Chemotherapy / Tmab for HER2-positive BC
Scientific Title Randomized Phase II Study of Neoadjuvant Chemotherapy and Trastuzumab (Herceptin) for Operable Breast Cancer with Overexpression of HER2
Scientific Title:Acronym Phase II study of Neoadjuvant Chemotherapy / Tmab for HER2-positive BC
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To determine more effective regimen which will show higher pathological complete response rate (pCR) by comparison between CEF(CPA/EPI/5-FU) followed by Trastuzumab / weekly paclitaxel and CEF followed by Trastuzumab / tri-weekly docetaxel in neoaduvant setting for primary breast cancer with overexpression of HER2.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Pathological CR (pCR) rate
Definition: no evidence of residual cancer in axillary lymph node and no evidence of residual invasive cancer in breast
Key secondary outcomes Disease-Free Survival
Adverse Events in neoadjuvant therapy
PK study of Neoadjuvant Trastuzumab
(10 patients of each arm)
To evaluate predictive factors of pCR by cDNA array

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 CPA/EPI/5-FU(500/100/500)/q3wks x 4 followed by paclitaxel(80)/qwk x 12/Trastuzumab/q3wks x 4
Interventions/Control_2 CPA/EPI/5-FU(500/100/500) x 4 followed by docetaxel (75)/q3wks x 4/Trastuzumab/q3wks x 4
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
18 years-old <=
Age-upper limit
65 years-old >=
Gender Female
Key inclusion criteria 1. Histologically confirmed invasive, but non-
inflammatory carcinoma of the breast
confirmed by core-needle biopsy
2. Clinical stage II to IIIA and satisfy criteria
as below
Tumor size: Less than 2cm and axillary node
positive diagnosed by ultrasound
or
Tumor size: More than 2cm diagnosed by
ultrasound
3. In multifocal tumor on the ipsilateral
breast, at least one tumor satisfies
criteria 2.
4. Case with simultaneous cancer on the both
breasts, or metachronous breast cancer,
is excluded
5. Overexpression of HER2 by IHC 3+ or
FISH +
6. Hormone-sensitivity of primary tumor is no
object
7. PS (ECOG) 0-2
8. Adequate organ function as below
[Bone marrow]
White blood cell count >= 3,000/uL,
or
granulocyte count >= 1,500/uL
Platelet count >= 100,000/uL
[Liver function]
AST and ALT <= 60IU/L
Total Bilirubin <= 1.5mg/dL
[Renal function]
Serum creatinine <= 1.5mg/dL
[Cadiac function]
(1) ECG normal or minor abnormality with
no-need of treatment
(2) No history of ischemic cardiac disease, or
cardiomyopathy
(3) Ejection fraction more than 60% by
ultrasound
9. Written informed consent
Key exclusion criteria 1. Pregnant and nursing
2. Concomitant infectious disease
3. History of hypersensitivity to Cremophor EL(polyoxethylated castor oil) or polysorbate
4. Interstitual pneumonia or lung fibrosis
5. Hepatitis Virus B antigen positive
6. Diabetes Mellitus with uncontrolled status or insulin-therapy
7. Difficulty to participate because of mental disorder
8. Simultaneous double-cancer (exclude carcinoma in situ)
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Ando, MD
Organization National Cancer Center Hospital
Division name Department of breast, first outpatient division
Zip code
Address Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Ando, MD
Organization National Cancer Center Hospital
Division name Department of breast, first outpatient division
Zip code
Address Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Homepage URL
Email Herceptin_trial_office@ml.res.ncc.go.jp

Sponsor
Institute Office for cordination of Herceptin trial
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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 YES
Study ID_1 18-3806
Org. issuing International ID_1 PMDA
Study ID_2
Org. issuing International ID_2
IND to MHLW 2007/3/12

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2007 Year 03 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.sciencedirect.com/science/article/pii/S1526820911002047
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 Completed
Date of protocol fixation
2006 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2007 Year 03 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 04 Month 01 Day
Date trial data considered complete
2009 Year 05 Month 01 Day
Date analysis concluded
2009 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 03 Month 23 Day
Last modified on
2012 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000780

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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