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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000748
Receipt No. R000000856
Scientific Title A Randomized Multicenter Phase2 Trial of Neoadjuvant Paclitaxel followed by Fluorouracil,Epirubin,and Cyclophosphamide(FEC)with or without Estrogen Deprivation by LH-RH agonist or Aromatase Inhibitor in Breast Cancer larger than 2 cm.
Date of disclosure of the study information 2007/06/30
Last modified on 2017/06/20

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Basic information
Public title A Randomized Multicenter Phase2 Trial of Neoadjuvant Paclitaxel followed by Fluorouracil,Epirubin,and Cyclophosphamide(FEC)with or without Estrogen Deprivation by LH-RH agonist or Aromatase Inhibitor in Breast Cancer larger than 2 cm.
Acronym A Randomized Multicenter Phase2 Trial of Neoadjuvant Paclitaxel followed by Fluorouracil,Epirubin,and Cyclophosphamide(FEC)with or without Estrogen Deprivation by LH-RH agonist or Aromatase Inhibitor in Breast Cancer larger than 2cm.
(NACED Randomized Multicenter Phase2 Trial)
Scientific Title A Randomized Multicenter Phase2 Trial of Neoadjuvant Paclitaxel followed by Fluorouracil,Epirubin,and Cyclophosphamide(FEC)with or without Estrogen Deprivation by LH-RH agonist or Aromatase Inhibitor in Breast Cancer larger than 2 cm.
Scientific Title:Acronym A Randomized Multicenter Phase2 Trial of Neoadjuvant Paclitaxel followed by Fluorouracil,Epirubin,and Cyclophosphamide(FEC)with or without Estrogen Deprivation by LH-RH agonist or Aromatase Inhibitor in Breast Cancer larger than 2cm.
(NACED Randomized Multicenter Phase2 Trial)
Region
Japan

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

Objectives
Narrative objectives1 To investigate if simultaneous addition of estrogen deprivation treatment by either aromatase inhibitor(AI) or LHRH-A in breast cancer patients increases pathological CR in preoperative systemic chemotherapy. In hormonal receptor positive breast cancers, the rate of pathological CR in Taxol followed by FEC100 with or without estrogen deprivation by either AI in postmenopausal or LHRH-A in premenopausal is investigated in a randomized P-2 fashion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The rate of pathological CR
Key secondary outcomes The rate of breast conservation operation, side effect, response rate, disease free survival, overall survival

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Premenopausal patients;
Chemotherapy+estrogen deprivation group
1)Eighty mg/m2 of Taxol once a week for 12 weeks are given intravenously,then
2)FEC100 ( 500mg/m2 of 5-FU, 100mg/m2 of epi-ADM, 500mg/m2 of CPA) is given once a three weeks for 12weeks.
3)3.75mg/body of LHRH-A once a month for 6 months is given subdermally initiated within 2 weeks of the first Taxol.
Interventions/Control_2 Premenopausal patients;
Chemotherapy group
1)Eighty mg/m2 of Taxol once a week for 12 weeks are given intravenously, then
2)FEC100 ( 500mg/m2 of 5-FU, 100mg/m2 of epi-ADM, 500mg/m2 of CPA) is given once a three weeks for 12weeks.
Interventions/Control_3 Postmenopausal patients;
Chemotherapy group
1)Eighty mg/m2 of Taxol once a week for 12 weeks are given intravenously,then
2)FEC100(500mg/m2 of 5-FU,100mg/m2 of epi-ADM, 500mg/m2 of CPA)is given once a three weeks for 12weeks.
3)Twenty-five mg a day of Exemestan is given orally initiated within 2 weeks of the first Taxol for consecutive 6 months until one day before the operation.
Interventions/Control_4 Postmenopausal patients
Chemotherapy group
1)Eighty mg/m2 of Taxol once a week for 12 weeks are given intravenously,then
2)FEC100 ( 500mg/m2 of 5-FU, 100mg/m2 of epi-ADM, 500mg/m2 of CPA) is given once a three weeks for 12weeks
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

Not applicable
Gender Female
Key inclusion criteria Inclusion Criteria
Eligible patients should meet all of the followings.
1)Eligible patients have histologically confirmed breast cancer who have no metastatic lesions except axillary lymphnode(s).
2)Tumor is larger than 2cm by any means of diagnostic imaging.
3)Patients with Performance status of 0 or 1(ECOG).
4)Patients should be older than 20 yrs.
5)No history of previous treatment of the present illness (chemotherapy, hormonal therapy, irradiation or surgery). Hormone replacement therapy is allowed if it has been discontinued 6 months before the trial.
6)Normal organ function with the following values;
1.WBC; greater than 4,000/mm3 or Neutrophil;greater than 2,000/mm3
2.PLT;greater than 10,000/mm3
3.Hgb;greater than 9.0g/dl
4.AST and ALT;no more than twice of the normal limit set by each insutitute.
5.T Bil.;no more than x 1.25 times of the normal limit set by each institute
6.Serum creatinine;no more than 1.5 times of the normal limit set by each institute.
7.Ejection fraction (EF) : greater than 60percent
8.ECG;normal without serious heart disease and arrhythmia.
7)Obtained written informed consent.
Key exclusion criteria Exclusion Criteria
1)Previous history of treatment with taxol, Anthracyclines and hormonal treatment.
2)Infection, uncontrollable diabetes mellitus, severe heart disease, angina with poor control, myocardial infarction within 6 months, active ulcers, multiple cancers, severe neuropathy or any other severe complications.
3)interstitial pneumonia and lung fibrous disease which needs treatment.
4)liver cirrhosis.
5)stage-4 disease with metastasis.
6)Pleural effusion, ascites, pericardial effusion.
7)Coagulopathy including DIC. Pregnancy , possibility of pregnancy and breast feeding.
8)History of severe allergic reactions.
9)allergy to Clemophor.
10)allergic to TXL, 5FU, EpiADM, CPM, LHRH-A(premenopausal), exemestan (postmenopausal).
11)allergic to alcohol.
12)active multiple malignancies.
13)patients judged to be inadequate to accrue
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jyunji Matsuoka M.D.,Ph.D.
Organization Okayama University Graduate School of Medicine and Dentistry and Pharmaceutical Science
Division name Department of Gastroenterological Surgery Transplant and Surgical Oncology
Zip code
Address 2-5-1 Shikata-cho,Okayama 700-8558,JAPAN
TEL 086-235-7257
Email

Public contact
Name of contact person
1st name
Middle name
Last name Jyunji Matsuoka M.D.,Ph.D.
Organization The FIRST
Division name Department of Gastroenterological Surgery Transplant and Surgical Oncology, Okayama University
Zip code
Address 2-5-1 Shikata-cho,Okayama 700-8558,JAPAN
TEL 086-235-7257
Homepage URL
Email doumon@cc.okayama-u.ac.jp

Sponsor
Institute THE FIRST
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Hirosima city Hosp.Chugoku central Hosp.Kagawa Rosai Hosp.Himeji Red Cross Hosp.Okayama Saiseikai Gen.HP et al.
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
2007 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results The primary endpoint was the pathological complete response (pCR) rate after neoadjuvant therapy. Twenty-eight patients were randomized. There were no significant differences in pCR rate between the concurrent group (12.5%;2/16) and the chemotherapy alone group (8.3%;1/12). Tumor size after therapy was significantly reduced in the concurrent therapy group (p=0.035), but not in the chemotherapy-alone group (p=0.622). Neoadjuvant chemotherapy with concurrent hormone therapy provided no significant improvement in pCR rate in ER-positive breast cancers. These preliminary results should be followed up by further studies.
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
2007 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
2017 Year 06 Month 20 Day
Date of closure to data entry
2017 Year 06 Month 20 Day
Date trial data considered complete
2017 Year 06 Month 20 Day
Date analysis concluded
2017 Year 06 Month 20 Day

Other
Other related information

Management information
Registered date
2007 Year 06 Month 26 Day
Last modified on
2017 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000856

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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