UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007103 |
|---|---|
| Receipt number | R000007300 |
| Scientific Title | Feasibility study of TC (docetaxel/cyclophosphamide) as neoadjuvant chemotherapy for primary breast cancer with negative HER2 |
| Date of disclosure of the study information | 2012/01/20 |
| Last modified on | 2018/05/14 16:52:50 |
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Basic information
Public title
Feasibility study of TC (docetaxel/cyclophosphamide) as neoadjuvant chemotherapy for primary breast cancer with negative HER2
Acronym
Neoadjuvant TC(docetaxel/cyclophosphamide) therapy for HER2 negative breast cancer
Scientific Title
Feasibility study of TC (docetaxel/cyclophosphamide) as neoadjuvant chemotherapy for primary breast cancer with negative HER2
Scientific Title:Acronym
Neoadjuvant TC(docetaxel/cyclophosphamide) therapy for HER2 negative breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Surgery in general |
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effficacy and safety of docetaxel with cyclophosphamide for HER2-negative breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Objective response rate
Key secondary outcomes
Breast-conserving rate
Pathological complete response rate
Safety
Disease free survival, Overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Docetaxel 75mg/m2, Cyclophosphamide 500mg/m2 on day 1, every 3 weeks for 4 cycles.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Histologically-confirmed invasive breast cancer
2. Age between 20 and 70 years
3.HER2-negative tumor
4.ECOG performance status 0 to 1
5.No prior therapy including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy for present primary breast cancer
6 .Sufficient organ function (e.g. bone marrow, cardiac, liver and renal)
7. No interstitial pneumonia or pulmonary fibrosis diagnosed by chest CT scan.
8. Presence of evaluable primary lesion before and after treatment by CT, MRI or ultrasound. The evaluation must be based on the same modality.
9. Patient who is considers onsidered eligible for neoadjuvant chemotherapy
10. Written informed consent
Key exclusion criteria
1. Bilateral breast cancer
2. Male breast cancer
3. With active another cancer
4. History of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
5. History of hypersensitivity reaction to any drugs which are to be used in this study
6. Uncontrolled underlying medical conditions
7. Patients who need concurrent treatment by corticosteroids except for premedication
8. Severe psychiatric disorders
9. Pregnant or lactation women, or women with suspected pregnancy
10. Patients judged by the investigator to be unfit to be enrolled into the study
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Yamamoto |
Organization
Kumamoto University, Graduate School of Medical Sciences
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
1-1-1 Honjo, Kumamoto, 862-8556, Japan
TEL
096-373-5521
ys-yama@triton.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Tamura |
Organization
Kyushu Breast Cancer Study Group
Division name
Executive office
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL
092-801-2845
Homepage URL
http://www.chotsg.com/
npo@chotsg.com
Sponsor or person
Institute
Kyushu Breast Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
Non-profit Organization Clinical Hematology/Oncology Study Group
Organization
Division
Category of Funding Organization
Non profit foundation
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
Institutions
Institutions
北九州市立医療センター、社会保険久留米第一病院、福岡大学病院、聖マリア病院、九州医療センター、九州がんセンター、黒木クリニック（福岡県）熊本赤十字病院、むらたクリニック、熊本市民病院、熊本大学病院（熊本県）県立宮崎病院（宮崎県）宮良クリニック（沖縄県）福田ゆたか外科医院、長崎医療センター（長崎県）、博愛会相良病院、かねこクリニック（鹿児島県）、佐賀大学病院（佐賀県）、大分県立病院、うえお乳腺外科（大分県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 19 | Day |
Last modified on
| 2018 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007300
