UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030692 |
|---|---|
| Receipt number | R000035036 |
| Scientific Title | A phase II study of neoadjuvant chemotherapy with nab-paclitaxel followed by FEC in patitents with operable breast cancer |
| Date of disclosure of the study information | 2018/01/05 |
| Last modified on | 2018/01/05 12:17:01 |
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Basic information
Public title
A phase II study of neoadjuvant chemotherapy with nab-paclitaxel followed by FEC in patitents with operable breast cancer
Acronym
A phase II study of NAC with nab-paclitaxel for breast cancer
Scientific Title
A phase II study of neoadjuvant chemotherapy with nab-paclitaxel followed by FEC in patitents with operable breast cancer
Scientific Title:Acronym
A phase II study of NAC with nab-paclitaxel for breast cancer
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of neoadjuvant chemotherapy with nab-paclitaxel followed by FEC in patients with operable breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Rate of pathological complete response (pCR rate)
Key secondary outcomes
Breast-conserving surgery (BCS) rate, objective response rate (ORR), safety, disease-free survival, overall survival, pCR rates, ORR and BCS rates based on subtype. ORR and safety during nab-paclitaxel treatment.
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
Patients receive nab-paclitaxel 260 mg/m2 intravenously on a 21-day schedule for 4 cycles. After that, patients receive epirubicin 100mg/2, fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 intravenously on a 21-day schedule for 4 cycles.Patients receive surgery for breast cancer after neoadjuvant chemotherapy.
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
Histologically confirmed breast cancer
Clinical stage I - IIIB (T1-3, N0-2, M0)
ER, PgR and HER2 status are confirmed
Having measurable lesion according to RECIST version 1.1
No previous treatment for breast cancer
Having Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Having adequate organ function
Providing written informed consent for this trial
Key exclusion criteria
Having significant cardiovascular disease and a history of that
Having significant complications such as uncontrolled hypertension and diabetes mellitus, renal failure, liver failure, clinically significant infection and mental disorder
Pregnant, breast feeding and case of possibility of pregnancy
Bilateral breast cancer with concurrent or metachronism
Pulmonary fibrosis or interstitial pneumonia
Having a known hypersensitivity to the components of the study therapy
Cases judged unsuitable by the physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Yamamoto |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
1-1-1 Honjyo, Chuo-ku, , Kumamoto,860-8556, 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
Clinical Hematology Oncology Treatment Study Group
Division name
Kyushu Breast Cancer Study Group
Zip code
Address
1-8-17-204, Watanabe douri, Chuo-ku, Fukuoka, 810-0004, Japan
TEL
092-406-4166
Homepage URL
http://www.chotsg.com/kbc-sg/index.html
kbc@chotsg.com
Sponsor or person
Institute
kyushu Breast Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
kyushu Breast Cancer Study Group
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 05 | Day |
Last modified on
| 2018 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035036
