UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003493
Receipt number R000004232
Scientific Title Phase II study of neoadjuvant zoledronic acid therapy for early breast cancer patients
Date of disclosure of the study information 2010/04/15
Last modified on 2011/10/15 09:09:13

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Basic information

Public title

Phase II study of neoadjuvant zoledronic acid therapy for early breast cancer patients

Acronym

Phase II study of neoadjuvant zoledronic acid therapy

Scientific Title

Phase II study of neoadjuvant zoledronic acid therapy for early breast cancer patients

Scientific Title:Acronym

Phase II study of neoadjuvant zoledronic acid therapy

Region

Japan


Condition

Condition

early breast cancer

Classification by specialty

Hematology and clinical oncology Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of zoledronic acid in the neoadjuvant chemotherapy in early breast cancer patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Pathological response rate

Key secondary outcomes

pathological complete response rate, breast conservation rate, axillar lymph node complete response rate, distant metastasis-free survival, disease-free survival, overall survival, adverse effects, changes of disseminated tumor cells, circulating tumor cells, and circulating endothelial cells


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

Neoadjuvant chemotherapy: CEF (EpiADR 100mg/m2 D1, CPA 500mg/m2 D1, 5FU 500mg/m2 D1 per 3 weeks) 4 cycles, then weekly paclitaxel 80mg/m2 for 12 weeks.
zoledronic acid: 4mg + saline 100ml div for 15 minutes, per 3-4 weeks, 6 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) ECOG Performance status of 0 to 2
2) diagnosed as breast cancer with biopsy
3) T 3cm or more, or lymph-node positive stage IIA-Stage IIIB, HER2-negative primary breast cancer
4) Adequate organ function such as
(1) WBC: 3000 /cmm or more, and WBC< 12, 000 /cmm
(2) Hb: 9.0 g/dl or more
(3) Platelet : 100000 /cmm or more
(4) GOT/GPT: less than 3x upper normal limit
(5) T. Bil :1.5 mg/dl or less
(6) Cr: 1.5 mg/dl or less
(7) no cardiac dysfunction
(8) EF: 50% or more
5) A written informed consent is obtained

Key exclusion criteria

1) non-invasive or minimally-invasive breast cancer
2) stage IV or inflammatory breast caner
3) male breast cancer
4) Patients who have treated with endocrine therapy, chemotherapy, or radiation therapy
5) Patients with previous or concomitant active malignancy
6) Patients who have serious complication (infection, cardiac disease, lung fibrosis, interstitial pneumonitis, bleeding tendency, etc.)
7) HB hepatitis
8) Patients who have poor-controlled DM
9) Patients who have hypersensitivity to bisphosphonates
10) Patients who needs invasive dental procedures
11) Patients who is pregnant, lactating or willing to be pregnant
12) Other conditions judged as inappropriate for the study by the investigator

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shunji Takahashi

Organization

Cancer Institute Hospital

Division name

Division of Medical Oncology

Zip code


Address

3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan

TEL

03-3570-0488

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shunji Takahashi

Organization

Cancer Institute Hospital

Division name

Division of Medical Oncology

Zip code


Address

3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan

TEL

03-3570-0488

Homepage URL


Email

stakahas@jfcr.or.jp


Sponsor or person

Institute

Division of Medical Oncology and Breast Surgery, Cancer Institute 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

癌研有明病院(東京都)


Other administrative information

Date of disclosure of the study information

2010 Year 04 Month 15 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

Open public recruiting

Date of protocol fixation

2010 Year 01 Month 22 Day

Date of IRB


Anticipated trial start date

2010 Year 04 Month 01 Day

Last follow-up date

2015 Year 08 Month 01 Day

Date of closure to data entry

2015 Year 10 Month 01 Day

Date trial data considered complete

2015 Year 12 Month 01 Day

Date analysis concluded

2016 Year 01 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 04 Month 15 Day

Last modified on

2011 Year 10 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004232


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name