Unique ID issued by UMIN | UMIN000004025 |
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Receipt number | R000004841 |
Scientific Title | Study of Aprepitant / Palonosetron / Dexamethasone for nausea and vomiting induced chemotherapy for breast cancer. |
Date of disclosure of the study information | 2010/08/10 |
Last modified on | 2017/11/30 18:05:17 |
Study of Aprepitant / Palonosetron / Dexamethasone for nausea and vomiting induced chemotherapy for breast cancer.
Study of Aprepitant / Palonosetron / Dexamethasone for nausea and vomiting
Study of Aprepitant / Palonosetron / Dexamethasone for nausea and vomiting induced chemotherapy for breast cancer.
Study of Aprepitant / Palonosetron / Dexamethasone for nausea and vomiting
Japan |
Breast cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
To investigation the efficacy of Aprepitant/Palonosetron/Dexamethasone for nausea and vomiting induced AC/EC/FEC for adjuvant or neoadjuvant chemotherapy breast cancer.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
The proportion of patients with no emetic episodes and no rescue medication (Complete Response (CR)) for 5 days
Complete Control (CC) rate: defined as no emetic episodes, no rescue medication use, and no more than mild nausea for 5 days.
Time to Treatment Failure: time to first emetic episode or time to administration of rescue therapy, whichever occurred first
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
We use three anti emesis drugs (Aprepitant/Palonosetron/Dexamethasone) for this trial.
The treatment schedule of
1) Aprepitant is oral administrated 125mg before administration of 1 hour~1 hour 30min for chemotherapy. And oral administrated 80mg at after breakfast on day 2, 3.
2) Palonosetron is intravenous administrated slowly 30 seconds or more for 0.75mg before administration of chemotherapy.
3) Dexamethasone is intravenous administrated 9.9mg before administration of chemotherapy. And oral administrated 4mg at after breakfast and dinner on day 2-4.
20 | years-old | <= |
80 | years-old | > |
Female
1) Histological confirmation of breast Cancer.
2) aged 20 years or more.
3) The following treatment is planned.
Cyclophosphamide >= 500mg/m2
Doxorubicin >= 50mg/m2
Epirubicin >= 60mg/m2
4) adequate oran function, defined as WBC >= 3000/mm3 and/or Neu >=1,500/mm3 ,AST < 5.0xULN IU/L , ALT < 5.0xULN IU/L
5) performance status (PS) 0-2
6) written informed consent from the patients.
The exclusion criteria were as follows; patients were not eligible for this study if
1) Advanced or Recurrent breast Cancer.
2) child-pugh score > 9
3) they had undergone treatment with high emetic risk and moderate emetic risk chemotherapy by Japan society of clinical oncology prior to this study
4) they had undergone treatment with clarithromycin, ketoconazole, itraconazole within 7 days
5) they had undergone treatment with barbiturate, rifampicin, phenytoin, carbamazepine within 4 weeks.
6) they took warfarin.
7) they took oral contraceptive.
8) they had deep venous thrombosis
9) they had ascites or pleural effusion needs paracentesis treatment.
10) they had serious complication.
(intestinal paralysis, lung fibrosis, diabetes mellitus, heart failure, myocardial infarction, angina pectoris, renal failure, psychiatric disorder, cerebrovascular accident, active gastric ulcer, active duodenal ulcer.
11) they had an associated symptom (ex infectious disease) patient who can not administer dexamethasone for 4 days.
12) they had a brain metastasis or suspected case.
13) they were operated within 28 day before entry
14) they operated radiation therapy
15) they except referred to above, physician in charge of this trial gave a diagnosis the patient who can not joint this trail for the safety.
55
1st name | |
Middle name | |
Last name | Kenichi Inoue |
Saitama Cancer Center
Breast Medical Oncology
818 Ina-machi oaza komuro, kita-adachi-gun, Saitama, 362-0806, Japan
048-722-1111
1st name | |
Middle name | |
Last name | Toshihiro Kai |
Saitama Breast Cancer Clinical Study Group (SBCCSG)
Secretariat Division (Shintoshin Ladies' MammoClinic)
3F Captal building, 4-261-1 Kishiki-cho, Omiya-ku, Saitama-shi, 330-0843, Japan
048-600-1722
http://www.sbccsg.org/
toshikai@sbccsg.org
Saitama Breast Cancer Clinical Study Group(SBCCSG)
none
Self funding
NO
2010 | Year | 08 | Month | 10 | Day |
Partially published
Completed
2010 | Year | 07 | Month | 07 | Day |
2010 | Year | 08 | Month | 01 | Day |
2012 | Year | 08 | Month | 01 | Day |
2012 | Year | 08 | Month | 01 | Day |
2012 | Year | 10 | Month | 01 | Day |
2012 | Year | 12 | Month | 01 | Day |
2010 | Year | 08 | Month | 10 | Day |
2017 | Year | 11 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004841
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