UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013263
Receipt number R000015458
Scientific Title A phase 2 study of Neoadjuvant chemotherapy in Docetaxel plus Cyclophosphamide plus Trastuzumab with Operable HER2 Positive breast cancer
Date of disclosure of the study information 2014/02/28
Last modified on 2018/09/10 14:23:06

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Basic information

Public title

A phase 2 study of Neoadjuvant chemotherapy in Docetaxel plus Cyclophosphamide plus Trastuzumab with Operable HER2 Positive breast cancer

Acronym

A phase 2 study of Neoadjuvant chemotherapy in Docetaxel plus Cyclophosphamide plus Trastuzumab with Operable HER2 Positive breast cancer

Scientific Title

A phase 2 study of Neoadjuvant chemotherapy in Docetaxel plus Cyclophosphamide plus Trastuzumab with Operable HER2 Positive breast cancer

Scientific Title:Acronym

A phase 2 study of Neoadjuvant chemotherapy in Docetaxel plus Cyclophosphamide plus Trastuzumab with Operable HER2 Positive breast cancer

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of preoperative administration of Tri-weekly Docetaxel plus Cyclophosphamide plus Trastuzumab of 4 cycles in patients with HER2 Positive operable breast cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Pathological complete response rate

Key secondary outcomes

(1)Safety,adverse events
(2)Overall response rate
(3)Breast conserving rate


Base

Study type

Interventional


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

To evaluate the efficacy and safety of preoperative administration of Tri-weekly Docetaxel plus Cyclophosphamide plus Trastuzumab of 4 cycles in patients with HER2 positive operable breast cancer.

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

20 years-old <=

Age-upper limit

70 years-old >=

Gender

Female

Key inclusion criteria

1) Female primary breast cancer patients who are diagnosed as HER2 positive invasive breast cancer by needle biopsy or tissue biopsy. Resectable primary breast cancer (T1c-3 N0-1 M0) and tumor size is 7 cm or smaller.
2)Age between 20 to 70 years old
3)ECOG performance status (PS): 0-1
4)No previous treatments for breast cancer such as chemotherapy, hormone therapy, molecular target therapy, radiotherapy and immunotherapy.
5)Results from a laboratory test meet the following:
a)Leukocyte count is >=3000/mm3 or
b)Neutrophil count is >=2000/mm3
c)Hemoglobin >=9.0g/dL
d)Platelet >=100 000/mm3
e)AST and ALT <=x 2.0 of upper limit of normal (ULN)
f)Bilirubin (total bilirubin or direct bilirubin) <=1.5 of ULN
g)Serum creatinine <=x 1.5 of ULN
h)Baseline left ventricular ejection fraction (LVEF) is >=60% measured by echocardiography or MUGA scan.
6)Signed written informed consent

Key exclusion criteria

1)Poorly controlled complication (malignant hypertension, myocardial infarction , congestive heart failure, bleeding).
2)Multiple primary cancer
3)Synchronous bilateral breast cancer
4)Interstitial pneumonia and pulmonary fibrosis diagnosed by chest X-rays or CT scan.
5)Women who are pregnant, lactating or with childbearing potential
6)Hypersensitivity to any agents necessary in the planned treatment.
7)Serious peripheral neuropathy or serious edema
8)Pleural effusion or cardiac effusion which requires treatment
9)Complication which requires prior treatment with corticosteroid
10)Suspected infection
11)Ineligible based on decision of an investigator

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuya Taguchi

Organization

Kyoto Prefectural University of Medicine

Division name

Endocrine & Breast Surgery

Zip code


Address

465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto

TEL

075-251-5534

Email

ttaguchi@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Katsuhiko Nakatsukasa

Organization

Kyoto Prefectural University of Medicine

Division name

Endocrine & Breast Surgery

Zip code


Address

465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto

TEL

075-251-5534

Homepage URL


Email

kacchan@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyoto Prefectural University of Medicine

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



Other administrative information

Date of disclosure of the study information

2014 Year 02 Month 28 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2011 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 02 Month 25 Day

Last modified on

2018 Year 09 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015458


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name