UMIN-CTR Clinical Trial

Public title

A phase III study comparing T-DM1 with pertuzumab, trastuzumab and docetaxel in elderly patients with advanced stage HER2 positive breast cancer (JCOG1607, HERB TEA study)

Acronym

A phase III study comparing T-DM1 with pertuzumab, trastuzumab and docetaxel in elderly patients with advanced stage HER2 positive breast cancer (JCOG1607, HERB TEA study)

Scientific Title

A phase III study comparing T-DM1 with pertuzumab, trastuzumab and docetaxel in elderly patients with advanced stage HER2 positive breast cancer (JCOG1607, HERB TEA study)

Scientific Title:Acronym

A phase III study comparing T-DM1 with pertuzumab, trastuzumab and docetaxel in elderly patients with advanced stage HER2 positive breast cancer (JCOG1607, HERB TEA study)

Region

Japan

Condition

HER2 positive advanced breast cancer

Classification by specialty

Hematology and clinical oncology

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Randomized phase 3 trial to investigate non-inferiority of T-DM1 to combination therapy with trasutuzumab, pertuzumab and docetaxel in elderly patients with HER2-positive advanced breast cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

Overall survival

Key secondary outcomes

Progression-free survival, cumulative breast cancer specific survival, overall response rate, adverse events, serious adverse events, proportion of non-deteriorating of instrumental activities of daily living

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A: Trastuzumab (6 mg/kg, loading dose 8 mg/kg) + Pertuzumab (420 mg, loading dose 840 mg) + Docetaxel 60 mg/m2 q3w until Progression Disease (PD)

Interventions/Control_2

B: T-DM1 (3.6 mg/kg) q3w until PD

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

65

years-old

<=

Age-upper limit

79

years-old

>=

Gender

Female

Key inclusion criteria

1) Histologically proven breast cancer (invasive cancer).
2) Histologically proven HER2 positive. Presense/absence of overexpression of estrogen receptor (ER) was examined.
3) Advanced breast cancer with distant metastatsis.
4) Women aged 65 to 79 years old.
5) ECOG performance status (PS) of 0 or 1 for 65 to 74 years old and 0 to 2 for 75 to 79 years old.
6) A measurable lesion is not required.
7) No active brain metastasis requiring therapy.
8) Neither prior chemotherapy (cytotoxic drug) or prior anti-HER2 therapy (trastuzumab, lapatinib, pertuzumab or T-DM1) for advanced breast cancer.
9) Adequate baseline laboratory data within 14 days prior to registration:
1. neutrophil count >= 1,500 /mm3
2. hemogrobin >= 9.0mg/dL without blood transfution within 14 days
3. platelet count >= 100,000 /mm3
4. total bilirubin <= 1.5 mg/dL
5. AST <= 100 U/L
6. ALT <= 100 U/L
7. serum creatinin <= 1.2 mg/dL
10) Left ventricular ejection fraction (LVEF) >= 50% by newest cardiography
11) Written informed consent.

Key exclusion criteria

1. Simultaneous or metachronouss (within 5 years) malignancy except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers.
2. Active infection requiring systemic therapy.
3. Body temperature of 38.0 degrees Celsius or higher.
4. Severe psychiatric diseases.
5. Patients requiring systemic steroid medication or the other immunosuppressive drug.
6. Poorly controlled diabetes mellitus.
7. Poorly controlled hypertension.
8. Unstable angina pectoris or history of myocardial infarction within 6 months.
9. Poorly controlled valve disease, dilated or hypertrophic cardiomyopathy.
10. HBs antigen positive

Target sample size

330

Name of lead principal investigator

1st name
Middle name
Last name	Kenji Tamura

Organization

National Cancer Center Hospital

Division name

Department of Breast and Medical Oncology

Zip code

Address

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

TEL

03-3542-2511

Email

ketamura@ncc.go.jp

Name of contact person

1st name
Middle name
Last name	Akihiko Shimomura

Organization

JCOG1607 Coordinating Office

Division name

Department of Breast and Medical Oncology

Zip code

Address

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

TEL

03-3542-2511

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

National Cancer Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

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

国立病院機構北海道がんセンター（北海道）
岩手医科大学（岩手県）
東北大学病院（宮城県）
筑波大学医学医療系（茨城県）
自治医科大学（栃木県）
群馬県立がんセンター（群馬県）
埼玉県立がんセンター（埼玉県）
国立がん研究センター東病院（千葉県）
千葉県がんセンター（千葉県）
国立がん研究センター中央病院（東京都）
がん・感染症センター都立駒込病院（東京都）
国立病院機構東京医療センター（東京都）
昭和大学病院（東京都）
がん研究会有明病院（東京都）
虎の門病院（東京都）
聖路加国際病院（東京都）
東海大学医学部（神奈川県）
聖マリアンナ医科大学（神奈川県）
神奈川県立がんセンター（神奈川県）
北里大学医学部（神奈川県）
横浜労災病院（神奈川県）
新潟県立がんセンター新潟病院（新潟県）
静岡県立総合病院（静岡県）
静岡県立静岡がんセンター（静岡県）
愛知県がんセンター中央病院（愛知県）
国立病院機構名古屋医療センター（愛知県）
名古屋市立大学病院（愛知県）
近畿大学医学部（大阪府）
大阪国際がんセンター（大阪府）
国立病院機構大阪医療センター（大阪府）
岡山大学病院（岡山県）
国立病院機構呉医療センター・中国がんセンター（広島県）
広島大学病院（広島県）
広島市立広島市民病院（広島県）
国立病院機構福山医療センター（広島県）
広島市立安佐市民病院（広島県）
国立病院機構四国がんセンター（愛媛県）
国立病院機構九州がんセンター（福岡県）
北九州市立医療センター（福岡県）
国立病院機構長崎医療センター（長崎県）
熊本大学医学部（熊本県）
博愛会相良病院（鹿児島県）

Date of disclosure of the study information

2018

Year

01

Month

12

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

No longer recruiting

Date of protocol fixation

2017

Year

10

Month

20

Day

Date of IRB

2017

Year

12

Month

22

Day

Anticipated trial start date

2018

Year

01

Month

12

Day

Last follow-up date

2030

Year

07

Month

12

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

01

Month

12

Day

Last modified on

2023

Year

10

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034485