Unique ID issued by UMIN | UMIN000001214 |
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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 |
Phase II study of Neoadjuvant Letrozole and Docetaxel for Postmenopausal, Endocrine-responsive and Anthracycline non-responsive Breast Cancer (JBCRG-05)
JBCRG-05
Phase II study of Neoadjuvant Letrozole and Docetaxel for Postmenopausal, Endocrine-responsive and Anthracycline non-responsive Breast Cancer (JBCRG-05)
JBCRG-05
Japan |
Postmenopausal, hormone-receptor positive and primary breast cancer
Hematology and clinical oncology | Surgery in general | Breast surgery |
Malignancy
YES
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.
Safety,Efficacy
Exploratory
Explanatory
Phase II
Response rate
Pathological CR rate, Breast Conserving Surgery rate, Safety, Disease- free survival and Overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Letrozole 2.5mg daily for 12 weeks to 18 weeks and Docetaxel 75mg/m2 x 4 courses
50 | years-old | <= |
70 | years-old | > |
Female
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
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
33
1st name | Takahiro |
Middle name | |
Last name | Nakayama |
Graduate School of Medicine Osaka University
Department of Breast and Endocrine Surgery
565-0871
2-2 Yamadaoka Suita, Osaka 565-0871 Japan
06-6879-3772
nakayama-ta@mc.pref.osaka.jp
1st name | Katsumasa |
Middle name | |
Last name | Kuroi |
Japan Breast Cancer Research Group (JBCRG)
Head Office
103-0016
9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
03-6264-8873
https://jbcrg.jp/
office@jbcrg.jp
Japan Breast Cancer Research Group (JBCRG)
Japan Breast Cancer Research Group (JBCRG)
Self funding
Japan Breast Cancer Research Group (JBCRG)
9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
03-6264-8873
office@jbcrg.jp
NO
2008 | Year | 06 | Month | 27 | Day |
N/A
Unpublished
N/A
3
N/A
2019 | Year | 11 | Month | 21 | Day |
N/A
N/A
N/A
N/A
Terminated
2007 | Year | 07 | Month | 02 | Day |
2007 | Year | 09 | Month | 04 | Day |
2007 | Year | 08 | Month | 01 | Day |
2015 | Year | 02 | Month | 01 | Day |
2008 | Year | 06 | Month | 27 | Day |
2019 | Year | 11 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001477
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