UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007103
Receipt number R000007300
Scientific Title Feasibility study of TC (docetaxel/cyclophosphamide) as neoadjuvant chemotherapy for primary breast cancer with negative HER2
Date of disclosure of the study information 2012/01/20
Last modified on 2018/05/14 16:52:50

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Feasibility study of TC (docetaxel/cyclophosphamide) as neoadjuvant chemotherapy for primary breast cancer with negative HER2

Acronym

Neoadjuvant TC(docetaxel/cyclophosphamide) therapy for HER2 negative breast cancer

Scientific Title

Feasibility study of TC (docetaxel/cyclophosphamide) as neoadjuvant chemotherapy for primary breast cancer with negative HER2

Scientific Title:Acronym

Neoadjuvant TC(docetaxel/cyclophosphamide) therapy for HER2 negative breast cancer

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Medicine in general Hematology and clinical oncology Surgery in general
Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effficacy and safety of docetaxel with cyclophosphamide for HER2-negative breast cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Objective response rate

Key secondary outcomes

Breast-conserving rate
Pathological complete response rate
Safety
Disease free survival, Overall survival


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

Docetaxel 75mg/m2, Cyclophosphamide 500mg/m2 on day 1, every 3 weeks for 4 cycles.

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. Histologically-confirmed invasive breast cancer
2. Age between 20 and 70 years
3.HER2-negative tumor
4.ECOG performance status 0 to 1
5.No prior therapy including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy for present primary breast cancer
6 .Sufficient organ function (e.g. bone marrow, cardiac, liver and renal)
7. No interstitial pneumonia or pulmonary fibrosis diagnosed by chest CT scan.
8. Presence of evaluable primary lesion before and after treatment by CT, MRI or ultrasound. The evaluation must be based on the same modality.
9. Patient who is considers onsidered eligible for neoadjuvant chemotherapy
10. Written informed consent

Key exclusion criteria

1. Bilateral breast cancer
2. Male breast cancer
3. With active another cancer
4. History of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
5. History of hypersensitivity reaction to any drugs which are to be used in this study
6. Uncontrolled underlying medical conditions
7. Patients who need concurrent treatment by corticosteroids except for premedication
8. Severe psychiatric disorders
9. Pregnant or lactation women, or women with suspected pregnancy
10. Patients judged by the investigator to be unfit to be enrolled into the study

Target sample size

36


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yutaka Yamamoto

Organization

Kumamoto University, Graduate School of Medical Sciences

Division name

Department of Breast and Endocrine Surgery

Zip code


Address

1-1-1 Honjo, Kumamoto, 862-8556, Japan

TEL

096-373-5521

Email

ys-yama@triton.ocn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuo Tamura

Organization

Kyushu Breast Cancer Study Group

Division name

Executive office

Zip code


Address

7-45-1 Nanakuma, Jonan-ku, Fukuoka

TEL

092-801-2845

Homepage URL

http://www.chotsg.com/

Email

npo@chotsg.com


Sponsor or person

Institute

Kyushu Breast Cancer Study Group

Institute

Department

Personal name



Funding Source

Organization

Non-profit Organization Clinical Hematology/Oncology Study Group

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


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

北九州市立医療センター、社会保険久留米第一病院、福岡大学病院、聖マリア病院、九州医療センター、九州がんセンター、黒木クリニック(福岡県)熊本赤十字病院、むらたクリニック、熊本市民病院、熊本大学病院(熊本県)県立宮崎病院(宮崎県)宮良クリニック(沖縄県)福田ゆたか外科医院、長崎医療センター(長崎県)、博愛会相良病院、かねこクリニック(鹿児島県)、佐賀大学病院(佐賀県)、大分県立病院、うえお乳腺外科(大分県)


Other administrative information

Date of disclosure of the study information

2012 Year 01 Month 20 Day


Related information

URL releasing protocol


Publication of results

Partially 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

No longer recruiting

Date of protocol fixation

2011 Year 06 Month 08 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

2012 Year 01 Month 19 Day

Last modified on

2018 Year 05 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007300


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name