UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003835
Receipt number R000004533
Scientific Title UFT monotherapy as adjuvant chemotherapy for HER2 negative breast cancer patients who did not achieve pathologic complete response (non-pCR) after neoadjuvant chemotherapy: Phase 2 study.
Date of disclosure of the study information 2010/07/05
Last modified on 2014/01/28 20:50:43

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Basic information

Public title

UFT monotherapy as adjuvant chemotherapy for HER2 negative breast cancer patients who did not achieve pathologic complete response (non-pCR) after neoadjuvant chemotherapy: Phase 2 study.

Acronym

UFT monotherapy for non-pCR patients treated with neoadjuvant chemotherapy.

Scientific Title

UFT monotherapy as adjuvant chemotherapy for HER2 negative breast cancer patients who did not achieve pathologic complete response (non-pCR) after neoadjuvant chemotherapy: Phase 2 study.

Scientific Title:Acronym

UFT monotherapy for non-pCR patients treated with neoadjuvant chemotherapy.

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Hematology and clinical oncology Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To confirm the feasibility and safety of UFT monotherapy as adjuvant chemotherapy for HER2 negative breast cancer patients who did not achieve pathologic complete response after neoadjuvant chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

feasibility

Key secondary outcomes

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

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

UFT 270 mg/m2 (daily oral administration)

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

80 years-old >

Gender

Female

Key inclusion criteria

1. Female breast cancer patients over 20 who were histologically diagnosed as primary breast cancer (invasive carcinoma).
2. Stage II-III patients who underwent curative operation.
3. Cases with histologically diagnosed residual invasive cancer after preoperative chemotherapy including anthracycline.
4. HER2 negative cases.
5. 0 to 1 ECOG performance status.
6. No carry-over effect of prior treatment.
7. Good organ function.
8. Cases with no carry-over grade 2 or more adverse drug effect.
9. Written informed consent.

Key exclusion criteria

1. Necessary for adjuvant chemotherapies other than UFT.
2. Treated with oral 5-FU agents previously.
3. Pregnant or breastfeeding.
4. Willing for or possibilities of pregnancy.
5. Recieved the organ transplantation previously.
6. Hypersensitive or underwent severe adverse reactions to fluoropyrimidine.
7. Suffered from serious complications.
8. Having fever or possibility of the infection.
9. Metastatic breast cancer.
10. Having past history or treatment of epilepsy, central nurve system disorder, or psychiatric disease.
11. Difficulty with taking oral drugs or upper gastrointestinal function, or malabsorption syndrome.
12. Judged to be ineligible by the investigators.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuhiko Iwamoto

Organization

Osaka Medical College Hospital

Division name

General and gastroenterological surgery

Zip code


Address

Daigaku-machi 2-7, Takatsuki city Osaka, Japan

TEL

072-683-1221

Email

sur112@poh.osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoru Tanaka

Organization

Osaka Medical College Hospital

Division name

General and gastroenterological surgery

Zip code


Address

Daigaku-machi 2-7, Takatsuki city Osaka, Japan

TEL

072-683-1221

Homepage URL


Email

sur112@poh.osaka-med.ac.jp


Sponsor or person

Institute

Osaka Medical College Hospital

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



Other administrative information

Date of disclosure of the study information

2010 Year 07 Month 05 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

Terminated

Date of protocol fixation

2010 Year 06 Month 10 Day

Date of IRB


Anticipated trial start date

2010 Year 07 Month 01 Day

Last follow-up date

2017 Year 06 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 06 Month 28 Day

Last modified on

2014 Year 01 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004533


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name