UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006085
Receipt number R000007204
Scientific Title A feasibility study of sequential Anthracycline-based regimen and Nab-Paclitaxel / Trastuzumab followed by Trastuzumab as postoperative adjuvant chemotherapy for Her2 positive breast cancer.(SBCCSG-22)
Date of disclosure of the study information 2011/08/01
Last modified on 2018/12/18 20:10:30

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Basic information

Public title

A feasibility study of sequential Anthracycline-based regimen and Nab-Paclitaxel / Trastuzumab followed by Trastuzumab as postoperative adjuvant chemotherapy for Her2 positive breast cancer.(SBCCSG-22)

Acronym

Anthracycline, Nab-Paclitaxel and Trastuzumab in the adjuvant therapy of HER-2 positive breast cancer.(SBCCSG-22)

Scientific Title

A feasibility study of sequential Anthracycline-based regimen and Nab-Paclitaxel / Trastuzumab followed by Trastuzumab as postoperative adjuvant chemotherapy for Her2 positive breast cancer.(SBCCSG-22)

Scientific Title:Acronym

Anthracycline, Nab-Paclitaxel and Trastuzumab in the adjuvant therapy of HER-2 positive breast cancer.(SBCCSG-22)

Region

Japan


Condition

Condition

Primary breast cancer

Classification by specialty

Hematology and clinical oncology Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluate the feasibility and safety of adjuvant chemotherapy that are Anthracycline-based regimen followed by Nab-paclitaxel and Trastuzumab.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Feasibility

Key secondary outcomes

Safety
Overall survival
Disease free survival
Relation between Relative Dose Intensity (RDI) of Nab-Paclitaxel and Disease Free Survival ratio


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

For the postoperative adjuvant chemotherapy, Anthracycline Base is done four times, and administering Nab-Paclitaxel and Trastuzumab begins. Nab-Paclitaxel is administered in a dose of 260mg/m2 by once every three weeks for four cycles. Trastuzumab is administered in a loading dose of 8 mg / kg of body weight, followed by a dose of 6 mg / kg once three weeks, for one year.

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

70 years-old >

Gender

Female

Key inclusion criteria

1) Histologically confirmed breast cancer.
2) HER2 Overexpression (IHC 3+ or FISH +)
3) Stage I, IIA, IIB, IIIA
4) Age m than 20 years and less than 70 years.
5) ECOG performance status of 0 to 1
6) LVEF more than 55%
7) Within 6 weeks after surgery
8) Sufficient organ function
9) Required baseline laboratory parameters (within 14 days before registration):
Hb more than 9.0g/dl
WBC more than 3000 /mm3
Neu more than 1500 / mm3
Plt more than 100,000/mm3
AST less than 2.5 times ULN
ALT less than 2.5 times ULN
T-Bil less than 1.5mg/dl
Cre less than 1.5mg/dl
10) Signed informed consent of the patient for the registration.ore

Key exclusion criteria

1) Pregnant or lactation women.
2) History of other malignancies within the last 5 years.
3) History of bilateral breast cancer
4) History of serious allergy
5) Serious cardiac disfunction
6) Patients judged by the investigator to be unfit to be enrolled into the study.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenichi Inoue

Organization

Saitama Cancer Center

Division name

Breast Medical Oncology

Zip code


Address

818 Ina-machi oaza komuro, Kita-adachi-gun, Saitama, 362-0806, Japan

TEL

048-722-1111

Email

ino@cancer-c.pref.saitama.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshihiro Kai

Organization

Saitama Breast Cancer Clinical Study Group(SBCCSG)

Division name

Secretariat Division (Shintoshin Ladies' Mammo Clinic)

Zip code


Address

3F Capital building, 4-261-1 Kishiki-cho, Omiya-ku, Saitama-shi, 330-0843, Japan

TEL

048-600-1722

Homepage URL

http://www.sbccsg.org/

Email

toshikai@sbccsg.org


Sponsor or person

Institute

Saitama Breast Cancer Clinical Study Group(SBCCSG)

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

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


Other administrative information

Date of disclosure of the study information

2011 Year 08 Month 01 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

No longer recruiting

Date of protocol fixation

2011 Year 05 Month 09 Day

Date of IRB


Anticipated trial start date

2011 Year 08 Month 01 Day

Last follow-up date

2023 Year 12 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

2011 Year 07 Month 31 Day

Last modified on

2018 Year 12 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007204


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name