UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012444
Receipt number R000014562
Scientific Title Observational study of Pertuzumab in combination with Trastuzumab and Docetaxel in patients with metastatic HER2-positive breast cancer that have the history of Trastuzumab treatment
Date of disclosure of the study information 2013/11/29
Last modified on 2013/11/29 16:20:16

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Basic information

Public title

Observational study of Pertuzumab in combination with Trastuzumab and Docetaxel in patients with metastatic HER2-positive breast cancer that have the history of Trastuzumab treatment

Acronym

Observational study of Pertuzumab in patients with HER2-positive MBC with the history of Trastuzumab treatment

Scientific Title

Observational study of Pertuzumab in combination with Trastuzumab and Docetaxel in patients with metastatic HER2-positive breast cancer that have the history of Trastuzumab treatment

Scientific Title:Acronym

Observational study of Pertuzumab in patients with HER2-positive MBC with the history of Trastuzumab treatment

Region

Japan


Condition

Condition

metastatic breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to assess the efficacy and the safety of Pertuzumab in combination with Trastuzumab and Docetaxel for HER2 positive metastatic breast cancer with the history of Trastuzumab treatment.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Time to strategy failure

Key secondary outcomes

Overall survival
Disease free survival
Response rate
Safety


Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Administration of Pertuzumab and Trastuzumab with a starting dose of 840 mg and 8 mg/kg followed by 420 mg and 6 mg/kg as the second and subsequent doses and Docetaxel with a dose of 50-75 mg/m2 every 3 weeks.

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



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

80 years-old >=

Gender

Female

Key inclusion criteria

1. Patients recieving combination chemotherapy with Pertuzumab, Trastuzumab and Docetaxel.
2. Patients with breast cancer which is confirmed to be invasive breast cancer by histological examination.
3. Reccurent/inoperable HER2-positive breast cancer patients.
4. HER2(3+) by immunohistochemical or positive by fluorescence in situ hybridization methods.
5. Patients with the history of Trastuzumab treatment
6. Patients with a performance status (ECOG) of 0, 1, or 2.
7. Left ventricular ejection fraction (LVEF) is equal or greater than 50% measured by cardiac ultrasonography.
8. Patients with adequately maintained organ and bone marrow functions.
9. Patients who provided written informed consent by themselves in principle to participate in this trial.

Key exclusion criteria

1. Male patients
2. Patients with allergy to the medicines in this protocol treatment.
3. Active infection or fever suspicious of infection.
4. Pregnant women, nursing mothers, women with possibility of pregnancy or women with no intention to contraception.
5. Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hidemi Kawajiri

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Surgical Oncology

Zip code


Address

1-4-3 Asahi-machi, Abeno-ku, Osaka

TEL

06-6645-3838

Email

hkawajiri75@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hidemi Kawajiri

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Surgical Oncology

Zip code


Address

1-4-3 Asahi-machi, Abeno-ku, Osaka

TEL

06-6645-3838

Homepage URL


Email

hkawajiri75@yahoo.co.jp


Sponsor or person

Institute

Osaka City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

大阪市立大学医学部附属病院 乳腺内分泌外科病棟・外来(大阪府)


Other administrative information

Date of disclosure of the study information

2013 Year 11 Month 29 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2013 Year 08 Month 19 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 12 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 11 Month 29 Day

Last modified on

2013 Year 11 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014562


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name