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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007510
Receipt No. R000008864
Scientific Title A phase 2 study of weekly Nab-Paclitaxel followed by FEC (Fluorouracil, Epirubicin, Cyclophosphamide) as primary therapy for operable breast cancer
Date of disclosure of the study information 2012/03/16
Last modified on 2012/12/26

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Basic information
Public title A phase 2 study of weekly Nab-Paclitaxel followed by FEC (Fluorouracil, Epirubicin, Cyclophosphamide) as primary therapy for operable breast cancer
Acronym A phase 2 study of weekly Nab-Paclitaxel followed by FEC as primary therapy for operable breast cancer
Scientific Title A phase 2 study of weekly Nab-Paclitaxel followed by FEC (Fluorouracil, Epirubicin, Cyclophosphamide) as primary therapy for operable breast cancer
Scientific Title:Acronym A phase 2 study of weekly Nab-Paclitaxel followed by FEC as primary therapy for operable breast cancer
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the efficacy as measured by the pathological complete response (pCR) rate of weekly Nab-paclitaxel followed by FEC for the treatment of operable breast cancer.
Basic objectives2 Others
Basic objectives -Others Efficacy and safety as measured by the pCR rate for each biological subtype of breast cancer, breast conservation rate, and rate of adverse effects.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Pathological complete response rate.
Key secondary outcomes Pathological complete response rate by breast cancer subtype,
breast conservation rate,
frequency of adverse effects.

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 Four courses of weekly Nab-pacltaxel is followed by 4 courses of FEC100.

[Weekly Nab-paclitaxel]
Nab-paclitaxel at a dose of 100mg/m2 is administered on days 1, 8, and 15, of a 28 day cycle, for 4 cycles.

[FEC100]
Fluorouracil at a dose of 500 mg/m2, Epirubicin 100 mg/m2, and Cyclophosphamide 500 mg/m2 respectively, are administered on day 1 of a 21 day cycle, for 4 cycles.

* For HER2 over-expressed cases, trastuzumab is administered weekly during the Nab-paclitaxel phase concurrently.

* For hormone responsive cases, LH-RH angonist and/or aromatase inhibitor use is permitted.

Operation is to be performed within 8 weeks of the last chemotherapy day.
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. Pathologically confirmed primary breast cancer.
2. Age 20 or over.
3. Clinical T1-3, N0-2, M0 cases.
4. Curative by primary chemotherapy and surgery.
5. Performance status (ECOG) 0 or 1.
6. Has measurable lesion.
7. With no prior surgery, radiation, chemotherapy, nor hormonal therapy.
8. The below criteria met within 14 days prior to therapy;
(1) WBC between 4,000/mm3 and 12,000/mm3.
(2) Granulocyte count 2,000/mm3 or over.
(3) Platelet count 100,000/mm3 or over.
(4) Hb 9.0 g/dl or over.
(5) Serum total bilirubin 1.5 mg/dL or under.
(6) AST and ALT below 2.5 times the institute upper limit.
(7) Serum creatinine 1.5 mg/dL or under.
(8) Cardiac function: left ventricle ejection fraction 55 % or over by cardiac sonography or MUGA scan.
(9) EKG within normal limits.
9. Written consent obtained from the patient.
Key exclusion criteria 1. Cases with prior history of hypersensitivity reaction to the drugs or solvents (e.g. albumin, paclitaxel) used in this protocol.
2. Bilateral breast cancer cases.
3. Cases with inflammatory breast cancer.
4. Male breast cancer cases.
5. Cases with active secondary malignancy (current secondary malignancy or other malignancy within 5 years) .
6. Cases with conditions with the potential to compromise the planned treatment, such as cases with active infection, diarrhea, intestinal paralysis, intestinal obstruction, uncontrolled diabetes, uncontrolled angina and myocardial infarction within 6 months, heart failure, and other serious conditions.
7. Pregnant or breast feeding cases.
8. Cases with pulmonary fibrosis or interstitial pneumonia.
9. Cases with severe myelodepression, renal or liver dysfunction.
10. Cases in which the treating physician deems inappropriate to be entered into this study for other reasons.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Kamada
Organization Nahanishi Clinic
Division name Division of Surgery
Zip code
Address 2-1-9 Akamine, Naha, Okinawa, Japan
TEL 098-858-5557
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nobumitsu Tamaki
Organization Nahanishi Clinic
Division name Division of Surgery
Zip code
Address 2-1-9 Akamine, Naha, Okinawa, Japan
TEL 98-858-5557
Homepage URL
Email

Sponsor
Institute Nahanishi Clinic
Institute
Department

Funding Source
Organization Nahanishi Clinic
Organization
Division
Category of Funding Organization Self funding
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
2012 Year 03 Month 16 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 Terminated
Date of protocol fixation
2012 Year 02 Month 27 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2013 Year 02 Month 28 Day
Date of closure to data entry
2013 Year 03 Month 31 Day
Date trial data considered complete
2013 Year 04 Month 30 Day
Date analysis concluded
2013 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 15 Day
Last modified on
2012 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008864

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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