UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003355 |
|---|---|
| Receipt number | R000004074 |
| Scientific Title | Randomized phase II study of preoperative systemic chemotherapy of carboplatin/weekly paclitaxel followed by CEF versus weekly paclitaxel followed by CEF for operable HER2-negative breast cancer |
| Date of disclosure of the study information | 2010/03/22 |
| Last modified on | 2012/07/03 10:20:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized phase II study of preoperative systemic chemotherapy of carboplatin/weekly paclitaxel followed by CEF versus weekly paclitaxel followed by CEF for operable HER2-negative breast cancer
Acronym
Randomized phase II study of preoperative systemic chemotherapy of carboplatin/weekly paclitaxel followed by CEF versus weekly paclitaxel followed by CEF for operable HER2-negative breast cancer
Scientific Title
Randomized phase II study of preoperative systemic chemotherapy of carboplatin/weekly paclitaxel followed by CEF versus weekly paclitaxel followed by CEF for operable HER2-negative breast cancer
Scientific Title:Acronym
Randomized phase II study of preoperative systemic chemotherapy of carboplatin/weekly paclitaxel followed by CEF versus weekly paclitaxel followed by CEF for operable HER2-negative breast cancer
Region
| Japan |
Condition
Condition
Stage II and IIIA breast cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to compare pathelogical complete response rate of carboplatin/weekly paclitaxel followed by CEF and weekly paclitaxel followed by CEF, both given preoperatively for HER2-negative breast cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Pathological complete response rate, which is defined as the absence of viable invasive tumor in both the breast and the axillary nodes, or residual ductal carcinoma in situ (DCIS) in breast and no viable invasive tumor in the axillary nodes.
Key secondary outcomes
1) Disease-free survival
2) Clinical response rate
3) Adverse events
4) Breast-conservation rate
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
CBDCA/wPTX arm
Carboplatin AUC5/paclitaxel 80mg/m-2 (day 1, 8, 15) /q3wks x 4courese, followd by CEF(cyclophosphamide/epirubicin/5-fluorouracil 500/100/500mg/m-2/q3wks) x 4courses
Interventions/Control_2
wPTX arm
Paclitaxel 80mg/m-2 (day 1, 8, 15) /q3wks x 4 courese, followd by CEF(cyclophosphamide/epirubicin/5-fluorouracil 500/100/500mg/m-2/q3wks) x 4courses
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
Eligible patients has previously untreated, unilateral, histologically confirmed, invasive, non-inflammatory, breast carcinoma. Histologic confirmation of invasive cancer is performed by core needle biopsy (CNB). HER2 is negative. Patients with a tumor ≥ 2.1 cm at the largest dimension by ultrasonography, or < 2.1 cm with axillary lymph node metastasis clinically diagnosed as positive, are eligible (clinical stage II and IIIA). Patients with axillary nodes enlarged by > 1cm at the largest dimension according to ultrasonography are considered node positive.
Age is between 18 and 70 years.ECOG performance status is 0 to 2.Adequate bone marrow function. Written informed consent.
Key exclusion criteria
1) Patients during pregnancy or lactation
2) Active infectious disease
3) History of hypersensitivity for Cremophor® EL(polyoxethylated castor oil)
4) Interstitual pneumonia or lung fibrosis
5) HBs antigen positive
6) Uncontrolled diabetes
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Ando |
Organization
National Cancer Center Hospital
Division name
Breast and Medical Oncology
Zip code
Address
5-1-1Tsukiji , Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Ando |
Organization
National Cancer Center Hospital
Division name
Breast and Medical Oncology
Zip code
Address
5-1-1Tsukiji , Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Homepage URL
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Health and Labour Sciences Research Grants (Clinical Cancer Research) of the Ministry of Health, Labor, 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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
2010年2月26日 初回
Institutions
Institutions
HER2過剰発現のない乳癌に対する術前化学療法におけるCarboplatinの有用性の検討グループ
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 22 | 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
Completed
Date of protocol fixation
| 2010 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 18 | Day |
Last modified on
| 2012 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004074
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
