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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003355
Receipt No. 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

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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 &#8805; 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&reg; 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
Email

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
Email

Sponsor
Institute National Cancer Center Hospital
Institute
Department

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
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 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
URL(English) https://upload.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


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