UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006286
Receipt number R000007440
Scientific Title Randomized study of tamoxifen versus goserelin acetate vs combination as preoperative endocrine therapy for estrogen receptor positive pre-menopausal patients.
Date of disclosure of the study information 2011/09/05
Last modified on 2015/03/13 11:35:14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Randomized study of tamoxifen versus goserelin acetate vs combination as preoperative endocrine therapy for estrogen receptor positive pre-menopausal patients.

Acronym

Randomized study of tamoxifen versus goserelin acetate versus combination as preoperative endocrine therapy.

Scientific Title

Randomized study of tamoxifen versus goserelin acetate vs combination as preoperative endocrine therapy for estrogen receptor positive pre-menopausal patients.

Scientific Title:Acronym

Randomized study of tamoxifen versus goserelin acetate versus combination as preoperative endocrine therapy.

Region

Japan


Condition

Condition

Estrogen receptor positive, pre-menopausal breast cancer

Classification by specialty

Hematology and clinical oncology Breast surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To compare the efficacy and safety of tamoxifen and goserelin acetate and combination as preoperative endocrine therapy for pre-menopausal patients. To find the patients who gain the benefit from each treatment.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Suppression of Ki-67

Key secondary outcomes

Safety
Response rate
Histopathological response
Predictive factor
Relapse-free 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 considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Group A: tamoxifen
Administration of 20mg tamoxifen daily for 8 weeks (day1-56)

Interventions/Control_2

Group B: goserelin acetate
Subcutaneous injection of goserelin acetate each 4 weeks for 8 weeks (day 1,28)

Interventions/Control_3

Group C: tamoxifen + goserelin acetate
1)Administration of 20mg tamoxifen daily for 8 weeks (day1-56)
2)Subcutaneous injection of goserelin acetate each 4 weeks for 8weeks (day 1,28)

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

30 years-old <=

Age-upper limit

55 years-old >

Gender

Female

Key inclusion criteria

1) Invasive breast cancer in pathological examination
2) 30 to 55 years old women who was comformed menstruation in recent 3 months
3) T1-2,N0,M0 in TNM classification
4) No previous chemotherapy, radiation, endocrine therapy, immunotherapy
5) Existance of measurable lesion
6)ER and/or PgR positive(IHC >10%)
7)HER2 negative
8)Performance Status 0-1
9)Sustained major organ funcrion
WBC >= 3,000/mm3,<=12,000/mm3
Netrophil >= 2,000/mm3
PLT >= 10x10 4/mm3
Hb >= 8.0 g/dl
AST(GOT),ALT(GPT)<=facility standard value x 1.5
T.Bili <=facility standard value x 1.25
Cre <= facility standard value x 1.5
Normal in electrocardiogram
10)Written informe consent

Key exclusion criteria

1) hypersensitivity to test drug
2) serious complication (malignant hypertention, congestive heart failure, coronary failure, cardiac infarction in last 6 month, arhythmia which need treatment, infection disease, bleeding tendency, etc.)
3) Patients who administrate anticlotting drug or SSRI
4)Patinent who have double cancer
5)Ductal carcinoma in situ or inflamatory breast cancer
6) Bilateral breast cancer, male breast cancer
7) Pregnant women, breat-feeding mother, possibility of pregnancy
8) History of thrombosis
9) History of mental disease or under medical treatment.
10)Patient regarded as inadequate by responsible doctor

Target sample size

220


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Daisuke Shimizu

Organization

Yokohama City Minato Red Cross Hospital

Division name

Breast Surgery

Zip code


Address

3-12-1 Shinyamashita, Naka-ku, Yokohama City, 231-8682, Japan

TEL

045-628-6100

Email

d-shimizu.surg@yokohama.jrc.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Daisuke Shimizu

Organization

Yokohama City Minato Red Cross Hospital

Division name

Breast Surgery

Zip code


Address

3-12-1 Shinyamashita, Naka-ku, Yokohama City, 231-8682, Japan

TEL

045-628-6100

Homepage URL


Email

d-shimizu.surg@yokohama.jrc.or.jp


Sponsor or person

Institute

Yokohama City University Medical Center

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


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

横浜市立大学附属市民総合医療センター(神奈川県)
聖マリアンナ医科大学医学部乳腺外科(神奈川県)
北里大学医学部乳腺外科(神奈川県)
東海大学医学部乳腺外科(神奈川県)
横浜市立大学医学部臨床腫瘍科乳腺外科(神奈川県)
神奈川県立がんセンター(神奈川県)
湘南記念病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2011 Year 09 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

Terminated

Date of protocol fixation

2011 Year 08 Month 10 Day

Date of IRB


Anticipated trial start date

2011 Year 09 Month 01 Day

Last follow-up date

2019 Year 08 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 09 Month 05 Day

Last modified on

2015 Year 03 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007440


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name