UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001214
Receipt number R000001477
Scientific Title Phase II study of Neoadjuvant Letrozole and Docetaxel for Postmenopausal, Endocrine-responsive and Anthracycline non-responsive Breast Cancer (JBCRG-05)
Date of disclosure of the study information 2008/06/27
Last modified on 2019/11/21 16:37:20

* 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

Phase II study of Neoadjuvant Letrozole and Docetaxel for Postmenopausal, Endocrine-responsive and Anthracycline non-responsive Breast Cancer (JBCRG-05)

Acronym

JBCRG-05

Scientific Title

Phase II study of Neoadjuvant Letrozole and Docetaxel for Postmenopausal, Endocrine-responsive and Anthracycline non-responsive Breast Cancer (JBCRG-05)

Scientific Title:Acronym

JBCRG-05

Region

Japan


Condition

Condition

Postmenopausal, hormone-receptor positive and primary breast cancer

Classification by specialty

Hematology and clinical oncology Surgery in general Breast surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Evaluation of the response rate, the pathological response and the safety of neoadjuvant Letrozole combined with Docetaxel x 4 courses for postmenopausal women with hormone receptor positive, operable and primary breast cancer which confirmed SD or PD in prior anthracycline-containing chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Pathological CR rate, Breast Conserving Surgery rate, Safety, Disease- free survival and 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

Letrozole 2.5mg daily for 12 weeks to 18 weeks and Docetaxel 75mg/m2 x 4 courses

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

50 years-old <=

Age-upper limit

70 years-old >

Gender

Female

Key inclusion criteria

1. Operable primary breast cancer(T1c-3 N0 M0 / T1-3 N1 M0: at first diagnosis).
2. Histological confirmed invasive breast cancer by biopsy.
3. Estorogen receptor(ER) and/or Progesterone receptor(PgR) positive by Immunohistochemistry(IHC; >=10%).
4. All of the following patients that received 2-4 cycles of anthracycline-containing regimen.
i) SD/PD on CT/MRI confirmed by RECIST
ii) >=75% relative dose intensity in one of the following regimens;
FEC75-100, AC 60/600, EC 75-90/600
iii) SD >= 3 cycles, PD >= 2 cycles
5. Postmenopausal women when receiving the anthracycline-containing chemotherapy
6. Measurable region
7. Adequate major organ function;
WBC >= 3,000/mm3 <= 12,000/mm3 or ANC >= 1,500/mm3
PLT >= 100,000/mm3
Hb >= 9.6 g/dl
AST, ALT <= 1.5 x ULN
T. Bil <= 1.25 x ULN
Serum Cr. <= 1.5
Nomal ECG
EF >= 60%
8. ECOG preformance status (P.S.): 0 and 1
9. Age: <= 70
10. Possible to provide the biopsy
specimens, isolated tissues and
blood samples for this study.
11. Written informed consent

Key exclusion criteria

1. Unmanageable serious complications
2. HCV
3. Unmanageable diabetes
4. Suspicious infection with fever
5. Active double cancer
6. Neuropathy
7. Edema
8. Inflammatory breast cancer
9. Bilateral breast cancer
10. History of drug-hypersensitivity
11. Under treatment of continuous systematic steroids, estrogen and raloxifene
12. Serious mental disease
13. Patient judged inappropriate for this study by the physicians

Target sample size

33


Research contact person

Name of lead principal investigator

1st name Takahiro
Middle name
Last name Nakayama

Organization

Graduate School of Medicine Osaka University

Division name

Department of Breast and Endocrine Surgery

Zip code

565-0871

Address

2-2 Yamadaoka Suita, Osaka 565-0871 Japan

TEL

06-6879-3772

Email

nakayama-ta@mc.pref.osaka.jp


Public contact

Name of contact person

1st name Katsumasa
Middle name
Last name Kuroi

Organization

Japan Breast Cancer Research Group (JBCRG)

Division name

Head Office

Zip code

103-0016

Address

9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan

TEL

03-6264-8873

Homepage URL

https://jbcrg.jp/

Email

office@jbcrg.jp


Sponsor or person

Institute

Japan Breast Cancer Research Group (JBCRG)

Institute

Department

Personal name



Funding Source

Organization

Japan Breast Cancer Research Group (JBCRG)

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

Japan Breast Cancer Research Group (JBCRG)

Address

9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan

Tel

03-6264-8873

Email

office@jbcrg.jp


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

2008 Year 06 Month 27 Day


Related information

URL releasing protocol

N/A

Publication of results

Unpublished


Result

URL related to results and publications

N/A

Number of participants that the trial has enrolled

3

Results

N/A

Results date posted

2019 Year 11 Month 21 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

N/A

Participant flow

N/A

Adverse events

N/A

Outcome measures

N/A

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2007 Year 07 Month 02 Day

Date of IRB

2007 Year 09 Month 04 Day

Anticipated trial start date

2007 Year 08 Month 01 Day

Last follow-up date

2015 Year 02 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

2008 Year 06 Month 27 Day

Last modified on

2019 Year 11 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001477


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name