UMIN-CTR Clinical Trial

Public title

AFTER trial

Acronym

Aromatase inhibitor or fulvestrant after becoming to resistance of ethinylestradiol in postmenopausal women with metastatic breast cancer - prospective comparing trial

Scientific Title

AFTER trial

Scientific Title:Acronym

Aromatase inhibitor or fulvestrant after becoming to resistance of ethinylestradiol in postmenopausal women with metastatic breast cancer - prospective comparing trial

Region

Japan

Condition

metastatic postmenopausal breast cancer with refractory to estrogen therapy

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

A prospective randomized comparative study on the clinical usefulness Aromatase inhibitor vs. fulvestrant after becoming to resistance of ethinylestradiol in postmenopausal women with metastatic breast cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Phase II,III

Primary outcomes

clinical benefit rate; CBR

Key secondary outcomes

Time to treatment failure, Response rate,
Time to chemotherapy, Overall survival,
Adverse events, Predictive factors

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

One of the 3rd generation aromatase inhibitors, such as Anastrozole (1mg),Letrozole (2.5mg) or Exemestane (25mg) is orally administered once a day.

Interventions/Control_2

Fulvestrant(500mg)is intramuscular injected day1, day15, day28, followed by every 28days

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

50

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1. The case signed informed consent of the patients for the registration
2. The case confirmed by pathological diagnosis
3. Post menopausal women with breast cancer (not less than 50 yo)
4. The case who had progressive disease during the estrogen (ethinyl-estradiol) treatment
5. The case with measurable metastatic / recurrent site or evaluable bone metastasis
6. The case that survival more than 3 months is anticipated
7. The case with PS 0,1 or 2
8. The case with a satisfactory function of a heart/liver/bone marrow and to satisfy the nest condition
Hb; more than 8 g/dL, AST and ALT; Lessthan 2.5 times of the normal value limit of the institution, BUN; not more than 25mg/dL, Crea; not more than 1.5 mg/dL

Key exclusion criteria

1. The case with active other malignancies
2. The case with HER2 positive tumor
3. The case with bilateral breast cancer
4. The case with inflammatory breast cancer
5. The case with past history of drug allergy or hypersensitivity
6. The case with severe progressive situation with non-indication ofr the hormone therapy
7. The case determined in appropriate by physicians

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Hirotaka Iwase

Organization

Graduate school of Medical Sciences,
Kumamoto University

Division name

Department of Breast and Endocrine Surgery

Zip code

Address

1-1-1 Honjo, Chuo-ku, Kumamoto

TEL

+81-96-373-5521

Email

hiwase@kumamoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Yutaka Yamamoto

Organization

Kumamoto University Hospital

Division name

Department of Breast Cancer Molecular Targeting Therapy

Zip code

Address

1-1-1 Honjo, Chuo-ku, Kumamoto

TEL

+81-96-373-5521

Homepage URL

http://www2.kuh.kumamoto-u.ac.jp/breast/index.html

Email

ys-yama@triton.ocn.ne.jp

Institute

Department of Breast and Endocrine Surgery
Graduate school of Medical Sciences,
Kumamoto University

Institute

Department

Personal name

Organization

Department of Breast and Endocrine Surgery
Graduate school of Medical Sciences,
Kumamoto University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

1773

Org. issuing International ID_1

Graduate school of Medical Sciences, Kumamoto University

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

熊本大学医学部附属病院（熊本県）、熊本市民病院（熊本県）、名古屋市立大学病院（愛知県）、北海道大学医学部附属病院（北海道）

Date of disclosure of the study information

2014

Year

05

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2014

Year

01

Month

20

Day

Date of IRB

Anticipated trial start date

2014

Year

05

Month

07

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

05

Month

06

Day

Last modified on

2014

Year

05

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016201