UMIN-CTR Clinical Trial

Public title

Phase II study of efficacy of letrozole in postmenopausal patients with endocrine-responsive, HER2-negative metastatic breast cancer resistant to exemestane or anastrozole.

Acronym

SBP-02

Scientific Title

Phase II study of efficacy of letrozole in postmenopausal patients with endocrine-responsive, HER2-negative metastatic breast cancer resistant to exemestane or anastrozole.

Scientific Title:Acronym

SBP-02

Region

Japan

Condition

Metastatic breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Examine the efficacy of therapy with letrozole for endocrine-responsive, HER2-negative metastatic breast cancer patients in postmenopausal women with tumor which has relapsed or progressed during treatment or after within 1 year by exemestane or anastrozole.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Clinical benefit rate

Key secondary outcomes

Response rate, Time to progression, Overall survival, Safety

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

EL: Letrozole(2.5 mg Tablet) is administered orally once a day for endocrine-responsive, HER2-negative metastatic breast cancer patients in postmenopausal women with tumor which has relapsed or progressed during treatment or after within 1 year by exemestane.

Interventions/Control_2

AL: Letrozole(2.5 mg Tablet) is administered orally once a day for endocrine-responsive, HER2-negative metastatic breast cancer patients in postmenopausal women with tumor which has relapsed or progressed during treatment or after within 1 year by anastrozole.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1. Patients who provided written informed consent by themselves in principle to participate in this trial.
2. Patients with a performance status (ECOG) of 2-0.
3. Patients who confirmed to be Amenorrhea past 1 year.
4. Patients whom the primary or metastatic lesion was confirmed to be breast cancer by histological examination.
5. Patients whom the primary or metastatic lesion was confirmed to be ER-positive and HER2-negative.Except for IHC 2+/not tested FISH
6. Patients with measurable metastatic by RECIST ver1.1
7. Patients who showed recurrence during or after treatment within 1 year of exemestane or anastrozole.
8. Patients with no history of treatment by letrozole.EL: Patients with no history of treatment by anastrozole.(AL: Does not matter for history of treatment by exemestane.)
9. Patients expected to survive for 3 months or more.
10. Patients who satisfies the following organ function.
(Using the latest Laboratory parameters within 30 days prior to enrollment.)
WBC: >= 2,000/mm3 or Neu: >= 1,000/mm3
Hb: >= 9.0g/dL
Plt: >= 100,000/mm3
T-Bil: <= 2 times ULN(upper limit of normal)
AST and ALT: <= 2 times ULN
Creatinin: <= 2 times ULN

Key exclusion criteria

1. Patients with active other malignancies.(other simultaneity malignancies and other heterochrony malignancies within 5 years disease-free interval)
*Except patients who cured carcinoma in situ or intramucosal carcinoma by local treatment.
2. Patients with brain metastasis with symptom.
3. Patients who confirmed to be unstable angina pectoris, congestive heart failure, myocardial infarction, myocardial infarction, ventricular arrhythmia that need treat within 6 months before register.
4. Patients who confirmed to be uncontrollable hypertension, diabetes when you register.
5. Patients with severe infectious disease.
6. Patients with severe complications
7. Patients who are receiving bisphosphonates for hypercalcemia by malignancy.(Except patients who had receiving bisphosphonates for osteoporosis, bone metastases.)
8. Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial.

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Masahiko Ikeda

Organization

Fukuyama City Hospital

Division name

Department of Breast and Thyroid Surgery

Zip code

Address

5-23-1 Zao-Cho, Fukuyama-City, Hiroshima, Japan, 721-8511

TEL

084-941-5151

Email

Name of contact person

1st name
Middle name
Last name	Tadahiko Shien

Organization

Setouchi Breast Project Comprehensive Organization

Division name

Clinical Research Group

Zip code

Address

2-5-1 Shikata Kita-ku Okayama Okayama Japan, 700-8558

TEL

086-235-7265

Homepage URL

Email

Institute

Setouchi Breast Comprehensive Support Organaization

Institute

Department

Personal name

Organization

Setouchi Breast Comprehensive Support Organaization

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

11

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2011

Year

10

Month

26

Day

Date of IRB

Anticipated trial start date

2011

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

11

Month

04

Day

Last modified on

2011

Year

11

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007834