UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003101
Receipt number R000003765
Scientific Title Evaluation of efficacy of letrozole as a neoadjuvant endocrine therapy in postmenopausal patients with hormone receptor-positive breast cancer
Date of disclosure of the study information 2010/01/28
Last modified on 2013/07/29 09:56:58

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Basic information

Public title

Evaluation of efficacy of letrozole as a neoadjuvant endocrine therapy in postmenopausal patients with hormone receptor-positive breast cancer

Acronym

Evaluation of efficacy of letrozole as a neoadjuvant endocrine therapy in postmenopausal patients with hormone receptor-positive breast cancer

Scientific Title

Evaluation of efficacy of letrozole as a neoadjuvant endocrine therapy in postmenopausal patients with hormone receptor-positive breast cancer

Scientific Title:Acronym

Evaluation of efficacy of letrozole as a neoadjuvant endocrine therapy in postmenopausal patients with hormone receptor-positive 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

Investigate change in hormone levels and clinical efficacy of preoperative letrozole treatment in postmenopausal patients with hormone receptor-positive breast cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Sex hormone levels and responsive genes at approximately 12-16 weeks after treatment of letrozole

Key secondary outcomes

Response rate, Pathological response, Safety


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

Neoadjuvant endocrine therapy (Letrozole)

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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1. Patients with noninvasive (including the suspicion) breast carcinoma, which was detected by US etc and diagnosed by biopsy etc, who hope the treatment by breast conserving surgery.
2. The breast carcinoma was positive for estrogen receptor (ER) by immunohistochemistry (more than Allred score 4 or more than 10% of ER-positive cells).
3. Postmenopausal women with breast carcinoma who apply to one or more following criteria.
1) Patients aged more than 60 years.
2) Patients aged less than 60 years old with amenorrhea (more than one year).
3) Patients who underwent bilateral oophorectomy.
*If menopausal status is unclear in patients aged less than 60 years, it is determined by serum FSH and E2 levels.
4. Patients without previous treatment for the breast cancer.
5. ECOG PS is 0-1.
6. Subjects must meet all of the following criteria for inclusion in the study.
1) AST/ALT: <2 times the upper limit of the normal range for the medical institution.
2) Serum creatinine: <1.5 times the upper limit of the normal range for the medical institution.
7. Patients who can provide biopsy tissue specimens, isolated tissues, and blood samples for investigation.
8. Patients from whom written informed consent to participation in the study has been obtained.

Key exclusion criteria

1. Synchronous or asynchrous bilateral breast cancer.
2. Patients receiving drugs having a potential influence on the status of sex hormones (hormone replacement therapy, raloxifene, etc.). (However, patients after washout for at least 8 weeks can be enrolled.)
3. Patients who are being treated of cerebral infarction at the time of the enrollment.
4. Patients with myocardial infarction or congestive heart failure at the past history, or patients who need treatment of ischemic hear disease, arryhythmia or valvular disorder.
5. Patients within 30 days after completion of treatment with the investigational drugs.
6. Patients whom doctors judged inadequate to the enrollment of this study by other reasons.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Suzuki

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Pathology and Histotechnology

Zip code


Address

2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi-ken

TEL

022-717-7947

Email



Public contact

Name of contact person

1st name
Middle name
Last name Takanori Ishida

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Surgical Oncology

Zip code


Address

2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi-ken

TEL

022-717-7214

Homepage URL


Email

tasuzuki-endo@umin.ac.jp


Sponsor or person

Institute

Tohoku University Graduate School of Medicine

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

Tohoku University Hospital, KKR Tohoku Kosai Hospital, Miyagi Cancer Center, Ishinomaki Red Cross Hospital, and Nihonkai General Hospital

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

2010 Year 01 Month 28 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


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

2009 Year 10 Month 13 Day

Date of IRB


Anticipated trial start date

2010 Year 01 Month 01 Day

Last follow-up date

2011 Year 12 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

2010 Year 01 Month 27 Day

Last modified on

2013 Year 07 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003765


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name