Unique ID issued by UMIN | UMIN000008423 |
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Receipt number | R000009912 |
Scientific Title | Single institute phase II study of neoadjuvant chemotherapy with trastuzumab and letrozole for postmenopausal ER-positive/HER2-positive breast cancers |
Date of disclosure of the study information | 2012/07/16 |
Last modified on | 2020/03/15 14:58:52 |
Single institute phase II study of neoadjuvant chemotherapy with trastuzumab and letrozole for postmenopausal ER-positive/HER2-positive breast cancers
NeoTL study
Single institute phase II study of neoadjuvant chemotherapy with trastuzumab and letrozole for postmenopausal ER-positive/HER2-positive breast cancers
NeoTL study
Japan |
Breast Cancer
Breast surgery |
Malignancy
NO
Evaluate efficacy of concurrent use of chemotherapy with trastuzumab and letrozole for postmenopausal breast cancers with ER-positive/HER2-positive.
Efficacy
Overall Response Rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
letrozole 2.5mg/day, 24 weeks
Not applicable |
75 | years-old | >= |
Female
1) Stage2A, 2B, 3A, 3B breast cancer
2) Histologically confirmed breast cancer
3) Postmenopausal women
4) ER- and/or PgR-positive (10% or more cancer cells were positive)
5) HER2-psotive (IHC score 3, or IHC score 2+ and FISH-positive)
6) 75 years old or less
7) Performance status 0 or 1
8) Breast cancers with evaluable lesion
9) Sufficient organ function meeting following criteria:
(1) Leukocyte > 3000 mm3 or Neutrophil >1500 mm3
(2) Hemoglobin >9.0g/dL
(3) Platelet >100000 mm3
(4) AST (GOT) and ALT(GPT) < 2.5 x upper limit of normal (ULN)
(5) Serum total bilirubin <1.5 mg/dL
(6) Serum creatinine <1.5 mg/dL
(7) Normal electrocardiogram
(8) LVEF is >55% measured by echocardiography or MUGA scan
10) No finding of pneumonitis or fobrosis by Chest CT or X-ray
11) MRI or CT of the breast must be done pre- and post-chemotherapy
12) No prior treatment for breast cancers
13) Signed written informed consent
1) Inflammatory breast cancer
2) Bilateral breast cancers without DCIS or ICIS
3) With multiple cancers diagnosed with 5 years
4) With uncontrollable hypertension, angina pectoris, congestive heart failure
5) With severe complication including infection or uncontrolled diabetes mellitus
6) With viral hepatitis (HBs antigen- or HCV antibody-positive)
7) Patients treated with endocrine therapy
8) Infection or possible infection associated with clinical symptoms such as fever
9) With severe edema
10) With severe mental disorder
11) Cases who physician judged improper to entry this trial
40
1st name | Yasuo |
Middle name | |
Last name | Miyoshi |
Hyogo College of medicine
Breast and endocrine Surgery
663-8501
Mukogawa 1-1, Ninshinomiya, Hyogo
0798-45-6374
ymiyoshi@hyo-med.ac.jp
1st name | Yasuo |
Middle name | |
Last name | Miyoshi |
Hyogo College of medicine
Breast and endocrine Surgery
663-8501
1-1 Mukogawa, Nishinomiya City, Hyogo, Japan
0798-45-6374
ymiyoshi@hyo-med.ac.jp
Department of Breast and Endocrine Surgery, Hyogo College of medicine
Breast and Endocrine Surgery, Hyogo College of Medicine
Self funding
Institutional Review Board of Hyogo College of Medicine
Mukogawa 1-1, Nishinomiya City
0798456374
rinri@hyo-med.ac.jp
NO
2012 | Year | 07 | Month | 16 | Day |
Unpublished
Unpublished
No publication
0
No patient was recruited.
2020 | Year | 03 | Month | 15 | Day |
No patient was recruited.
No patient was recruited.
No patient was recruited.
No patient was recruited.
Terminated
2012 | Year | 07 | Month | 10 | Day |
2012 | Year | 07 | Month | 25 | Day |
2012 | Year | 08 | Month | 01 | Day |
2014 | Year | 06 | Month | 30 | Day |
2012 | Year | 07 | Month | 13 | Day |
2020 | Year | 03 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009912
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