UMIN-CTR Clinical Trial

Public title

Study of neoadjuvant Letrozole combined with standerd chemotherapy for postmenopausal women with Endocrine-responsive Breast Cancer(subject of stage2,3A)

Acronym

Niigata Breast Cancer Trial-02

Scientific Title

Study of neoadjuvant Letrozole combined with standerd chemotherapy for postmenopausal women with Endocrine-responsive Breast Cancer(subject of stage2,3A)

Scientific Title:Acronym

Niigata Breast Cancer Trial-02

Region

Japan

Condition

Postmenopausal, hormone-receptor positive and resectable primary breast cancer

Classification by specialty

Hematology and clinical oncology

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Evaluation of the pathological response for neoadjuvant letorozole combined with anthracycline followed by taxane in postmenopausal women with hormone receptor positive Stage II or IIIA breast cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Pathological response

Key secondary outcomes

Clinical response rate,Breast Conserving Surgery rate,Safety

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Epirubicin 90-100 mg/m2, Cyclophosphamide 600 mg/m2, q3w x 4 cycles or Adriamycin 60 mg/m2, Cyclophosphamide 600 mg/m2, q3w x 4 cycles + Paclitaxel 80 mg/m2, weekly 12cycles and Letrozole 2.5mg p.o. daily for 24weeks over

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

Age-lower limit

60

years-old

<=

Age-upper limit

70

years-old

>

Gender

Female

Key inclusion criteria

1.Operable primary breast cancer(Stage2 ,3A at first diagnosis)
2.Postmenopausal patients who satisfies one or more below criteria;
A,Prior bilateral oophorectomy
B,>=60 years old < 70 years old
C,< 60 years old and amenorrheic for 12 months or more and FSH , plasma estradiol level in postmenopausal ranges
D,< 60 years old and after hysterectomy and FSH , plasma estradiol level in postmenopausal ranges
3.Measurable region
4.ER and/or PgR positive
5.PS 0-1(ECOG)
6.Adequate major organ function;
WBC >= 3,000/mm3, <= 12,000/mm3 or ANC >= 2,000/mm3
PLT >= 100,000/mm3
Hb >= 9.5 g/dl
GOT,GPT <=1.5 x ULN
Total bilirubin <= 1.25 x ULN
Serum creatinin <= 1.5
Cardiac function normal ECG
7.Patient judged appropriate for this study by the physicians
8.Written informed consent

Key exclusion criteria

1.Serious complications ( e.g malignant hypertension, CHF, hepatic failure, MI within 6 months, PE, arrhythmia treatment needed, infection, hemorrhagic tendency )
2.Hepatitis B
3.Serious Diabetes mellitus
4.Infection disease
5.Active multiple cancer
6.Edema
7.Inflammatory breast cancer
8.Synchronous bilateral breast cancer
9.History of drug-hypersensitivity
10.Patients have been treated with steroid or hormone replacement therapy or raloxifene
11.Mental disease
12.Osteoporosis, treated with bisphosphonate at present
13.Patient judged inappropriate for this study by the physicians

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Chizuko Kanbayashi

Organization

Niigata Cancer Center Hospital

Division name

Department of Surgery

Zip code

Address

2-15-3, Kawagishi-cho, Chuo-ku, Niigata-City 951-8566, Niigata Prefecture

TEL

025-266-5111

Email

Name of contact person

1st name
Middle name
Last name

Organization

Niigata Cancer Center Hospital

Division name

Department of Surgery

Zip code

Address

2-15-3, Kawagishi-cho, Chuo-ku, Niigata-City 951-8566, Niigata Prefecture

TEL

025-266-5111

Homepage URL

Email

Institute

Niigata Cancer Center Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

2009

Year

09

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

Suspended

Date of protocol fixation

2009

Year

05

Month

29

Day

Date of IRB

Anticipated trial start date

2009

Year

06

Month

01

Day

Last follow-up date

2016

Year

05

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

09

Month

04

Day

Last modified on

2012

Year

09

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002993