UMIN-CTR Clinical Trial

Public title

A Phase II Study of Neo-adjuvant Combination Therapy of Trastuzumab and Anastrozole for Hormone Receptor-Positive, HER2-Positive Postmenopausal Breast Cancer(WJOG7412B)

Acronym

"TRAstuzumab and ANAstrozole for breast cancer" WJOG7412B/Tra-Ana study

Scientific Title

A Phase II Study of Neo-adjuvant Combination Therapy of Trastuzumab and Anastrozole for Hormone Receptor-Positive, HER2-Positive Postmenopausal Breast Cancer(WJOG7412B)

Scientific Title:Acronym

"TRAstuzumab and ANAstrozole for breast cancer" WJOG7412B/Tra-Ana study

Region

Japan

Condition

Hormone receptor-positive, HER2-positive postmenopausal breast cancer

Classification by specialty

Hematology and clinical oncology

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Evaluating efficacy and safety of neoadjuvant combination therapy of trastuzumab and anastrozole in resectable hormone receptor-positive, HER2-positive postmenopausal breast cancer patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Pathological complete response rate

Key secondary outcomes

Safety, Response rate, Disease free survival, Overall survival, Breast conserving rate

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

Neoadjuvant Combination therapy of Trastuzumab and Anastrozole

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1)Pathologically confirmed resectable breast cancer Stage I-IIIB (T1-4 and N0-1)
2)Resectable at the day of enrollment
3)Hormone receptor-positive and HER2-positive (3+ staining by IHC or HER2 gene amplification [HER2:CEP17 signal ratio of 2.0 or more] by FISH) confirmed by pathology.
4)ECOG performance status 0-1
5)Postmenopausal (amenorrhea for at least one year/menopause due to bilateral ovariectomy)
6)Previously untreated with trastuzumab or aromatase inhibitors
7)No previous surgery or radiation therapy for ipsilateral breast
8)Adequate baseline organ and marrow function as defined below:
Absolute neutrophil count >= 1.5x10^9/L
Hemoglobin >= 9.0g/dL
AST and ALT <= 100IU/L
Serum bilirubin <= 1.5mg/dL
Serum creatinine <= 1.5mg/dL
9)Baseline left ventricular ejection fraction (LVEF) >= 50% by echocardiography
10)Signed written informed consent

Key exclusion criteria

1)Active infection under treatment
2)Concurrent serious disease or condition
3)Pulmonary fibrosis or interstitial pneumonitis by chest X-ray
4)Abnormal electrocardiography findings with clinical symptoms
5)Patients with other active malignancies
6)Concurrent serious psychiatric disorder
7)Concurrent massive body cavity fluid (pleural effusion, ascites or cardiac effusion, etc)needs treatment
8)Concurrent continuous systemic treatment with steroids
9)History of serious allergic reactions
10)HBsAg or HCVAb-positive
11)Patient considered irrelevant by the attending physician for the study

Target sample size

70

Name of lead principal investigator

1st name
Middle name
Last name	Akihiko Shimomura

Organization

National Cancer Center Hospital

Division name

Dept. of Experimental Therapeutics

Zip code

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045 Japan

TEL

03-3542-2511

Email

akihiko-sig@umin.ac.jp

Name of contact person

1st name
Middle name
Last name	Shinichiro Nakamura

Organization

West Japan Oncology Group

Division name

WJOG datacente

Zip code

Address

Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN

TEL

06-6633-7400

Homepage URL

Email

datacenter@wjog.jp

Institute

West Japan Oncology Group

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

2013

Year

06

Month

24

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

Terminated

Date of protocol fixation

2013

Year

05

Month

25

Day

Date of IRB

Anticipated trial start date

2013

Year

07

Month

25

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

06

Month

24

Day

Last modified on

2015

Year

05

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012906