UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000000748
Receipt number	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 11:48:09

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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

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Breast Cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

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

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

Intervention

No. of arms

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 or person

Institute

THE FIRST

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.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
Registered date	File name

1st name
Middle name
Last name	Jyunji Matsuoka M.D.,Ph.D.