UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000651 |
|---|---|
| Receipt number | 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 12:04:52 |
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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
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
Herceptin_trial_office@ml.res.ncc.go.jp
Sponsor or person
Institute
Office for cordination of Herceptin trial
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000780
