UMIN-CTR Clinical Trial

Public title

A Phase II study of pertuzumab+trastuzumab+capecitabine in Patients with taxans and trastuzumab refractory for advanced or recurrent breast cancer

Acronym

A Phase II study of pertuzumab+trastuzumab+capecitabine in Patients with taxans and trastuzumab refractory for advanced or recurrent breast cancer

Scientific Title

A Phase II study of pertuzumab+trastuzumab+capecitabine in Patients with taxans and trastuzumab refractory for advanced or recurrent breast cancer

Scientific Title:Acronym

A Phase II study of pertuzumab+trastuzumab+capecitabine in Patients with taxans and trastuzumab refractory for advanced or recurrent breast cancer

Region

Japan

Condition

HER2-positive metastatic breast cancer

Classification by specialty

Hematology and clinical oncology

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate effectiveness and safty of pertuzumab+trastuzumab+capecitabine in patients with taxans and trastuzumab refractory for advanced or recurrent breast cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Response rate

Key secondary outcomes

Progression-free survival
Overall survival
Clinical benefit rate
Time to treatment failure
safety profiles

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

pertuzumab+trastuzumab+capecitabine

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 invasive breast cancer.
2.>=20years old
3.HER2 positive (3+staining by immunohistochemistry or HER2 geneamplification signal ratio of 2.0 or more by FISH or DISH) confirmed in the invasive component of the primary or metastatic lesion.
4.Patients with taxans (docetaxel/paclitaxel/Nab-paclitaxel) refractory and previously treatments reportable
5.Patients without previous irradiation for terget lesion,but exclude the new lesion from previous irradiation points.
6.ECOG PS 0-2
7.Baseline LVEF>=50% by echocardiography or MUGA
8.Adequate baseline organ and marrow fuction as defined below Absolute neutrophil count >=1500mm3
hemmoglobin >=9.0g/dl
platelet count >=100000/mm3
AST/ALT 3 times of the facilities normal level
total bilirubin=<1.5mg/dl
serum creatinine=<1.5mg/dl (If patient with liver metastatic,5 times of the facilities normal leve to be able to enrolled )
9.Creatinine clearance>50mL/min.

Key exclusion criteria

1.Patients received capecitabine,pertuzumab. 2.Have hypersensitivity to Trastuzumab. 3.History of allergic reactions for capecitabine or fluoropyrimidines.
4.Patient during the therapy enforcement of immunity or hormon therapy. 5..During pregnancy or lactation. 6.Symptomatic brain metastasis. 7.With uncontrollable hypertension, angina, congestive heart failure, myocardial infection within 1 year, arrhythmia, valvular heart disease.
8.Pulmonary fibrosis or
pneumonia. 9.Dyspnea at rest. 10.With pleural effusion, ascites, pericardial effusion.
11Active infection or potentiality infection. 12.Serious drug allergy. 13.Active double cancer. 14.Only bone metastasis. 15.Judged by the investigator to be unfit to be enrolled into the study.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Tsuyoshi Saito

Organization

Saitama Red Cross Hospital

Division name

Department of breast surgery

Zip code

Address

8-3-33, Kamiochiai, Cyuo-ku, Saitama-city, Japan

TEL

048-852-1111

Email

tsaito@jcom.home.ne.jp

Name of contact person

1st name
Middle name
Last name	Tsuyoshi Saito

Organization

Saitama Red Cross Hospital

Division name

Department of breast surgery

Zip code

Address

8-3-33, Kamiochiai, Cyuo-ku, S

TEL

048-852-1111

Homepage URL

Email

tsaito@jcom.home.ne.jp

Institute

Saitama Breast Cancer Clinical Study 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

さいたま赤十字病院，埼玉県立がんセンター，埼玉社会保険病院，自治医大さいたま医療センター

Date of disclosure of the study information

2013

Year

10

Month

15

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

Enrolling by invitation

Date of protocol fixation

2013

Year

10

Month

08

Day

Date of IRB

Anticipated trial start date

2013

Year

10

Month

15

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

10

Month

14

Day

Last modified on

2017

Year

11

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014061