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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030692
Receipt No. 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

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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
Email 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
Email kbc@chotsg.com

Sponsor
Institute kyushu Breast Cancer Study Group
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035036

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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