UMIN-CTR Clinical Trial

Public title

Randomized controlled trial comparing Strontium-89 plus zoledronic acid with zoledronic acid alone as a treatment in patients with painful bone metastatic breast cancer

Acronym

JONIE 2 Study

Scientific Title

Randomized controlled trial comparing Strontium-89 plus zoledronic acid with zoledronic acid alone as a treatment in patients with painful bone metastatic breast cancer

Scientific Title:Acronym

JONIE 2 Study

Region

Japan

Condition

Breast Cancer

Classification by specialty

Hematology and clinical oncology

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To compare changes of bone resorption marker (NTX) and brief pain inventory (BPI) when given Strontium-89 plus zoledronic acid with zoledronic acid alone painful in bone metastatic breast cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Changes the proportion of patients uNTX at week13
Changes the proportion of patients BPI

Key secondary outcomes

Time to SRE were assessed
Dosing of analgesic drug
pain free of proportion patients
changes of bone resorption marker
Time to additional therapy to bone
changes of tumor marker
QOL
Adverse events

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients receive zoledronic acid 4mg function IV over 15 minutes infusion every 3-4 weeks for 12weeks (4-5 times infusion).

Interventions/Control_2

Patients receive strontium-89 2MBq/kg(maximum 141MBq) 1-2 miminutes iv on day 1 followed zoledronic acid every 3-4 weeks for 12weeks (3-4 times infusion).

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

18

years-old

<=

Age-upper limit

99

years-old

>=

Gender

Female

Key inclusion criteria

1)Cases of diagnosed breast cancer with bone metastases
2)Cases of diagnosed bone metastases by bone scintigraphy
3)ECOG performance status(PS)is 0 to 2
4)Cases of painful bone metastasis or using analgesic drug for bone pain and well contolled
5)Cases under chemotherapy or previous radiation therapy from outside of the body
6)serum creatinine is lower than 1.2 mg/dL,
creatinine clearance is higher than 60mL/min
7)WBC count is higher than 3,000/mm3,
Neutrophil count is higher than 1,500/mm3,
Platelet count is higher than 75,000/mm3,
Hemoglobin count is lower than 9.0g/dL
8)Not DIC
9)Patients with life expectancy of 12 weeks or longer from the initial registration.
10)Women at least 18 years of age
11)Patients who submitted written informed consent signed by the patient.

Key exclusion criteria

1)Cases with serious myelosupression
2)Cases with serious renal disorder
3)Cases with serious infection or interstitial pneumonia or pulmonary fibrosis
4)Cases with serious drug allergy
5)Cases in use of Denosumab
6)Pregnant patients or patients with possible pregnancy
7)Cases with active primary cancer without bone metastasis
8)Cases under invasive treatment of teeth
9)Cases that the investigator (subinvestigator) judged as inappropriate as the subject of this clinical study

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Norio Kohno

Organization

Tokyo Medical University Hospital

Division name

Breast Oncology

Zip code

Address

Nishisinjuku 6-7-1, Shinjuku-ku,Tokyo

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Tokyo Medical University Hospital

Division name

Breast Oncology

Zip code

Address

TEL

Homepage URL

Email

jonie@tokyo-med.ac.jp

Institute

JONIE Study Group

Institute

Department

Personal name

Organization

Kobe Breast Cancer Oncology Group

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

01

Month

11

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

No longer recruiting

Date of protocol fixation

2012

Year

10

Month

01

Day

Date of IRB

Anticipated trial start date

2012

Year

10

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

01

Month

11

Day

Last modified on

2013

Year

01

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011296