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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000014096 |
Receipt No. | R000015964 |
Scientific Title | A phase II study of S-1 (14days-administrarion followed by 7days-rest ) for Metastatic Breast Cancer |
Date of disclosure of the study information | 2014/06/01 |
Last modified on | 2018/03/05 |
Basic information | ||
Public title | A phase II study of S-1 (14days-administrarion followed by 7days-rest ) for Metastatic Breast Cancer | |
Acronym | A phase II study of S-1 (14days-administrarion followed by 7days-rest) for Metastatic Breast Cancer | |
Scientific Title | A phase II study of S-1 (14days-administrarion followed by 7days-rest ) for Metastatic Breast Cancer | |
Scientific Title:Acronym | A phase II study of S-1 (14days-administrarion followed by 7days-rest) for Metastatic Breast Cancer | |
Region |
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Condition | |||
Condition | Breast Cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate efficacy and safety of S-1 (14days-administrarion followed by 7days-rest) for Metastatic Breast Cancer |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Response Rate |
Key secondary outcomes | Disease control rate
Progression-free survival Time to failure Adverse events |
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 |
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Interventions/Control_1 | S-1 is administered orally twice daily at a dose of 40-60 mg (80-120 mg/day), depending on the BSA and creatinine-clearance from days 1 to 14, which is followed by 7 days rest.
This treatment is repeated until disease progressive. |
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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 |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | (1)Histologically confermed breast cancer patients of female
(2)Metastatic or recurrent breast cancer. 1) Patients with distant metastasis of breast cancer. 2) Refractory or recurrent breast cancer. Local recurrence is excluded. (3) Patients submitted written informed consent to participate in this clinical study. (4)Patients with measurable lesions based on RECIST v.1.1. (5) no prior chemotherapy or 1 to 2 regimens for metastatic or recurrent breast cancer. (6) Eastern Cooperative Oncology Group performance status 0,1 (7) 1)previously treated with no orally-administered fluorinated pyrimidine 2)more than 24weeks interval after adjuvant or neoadjuvant chemotherapy of orally-administered fluorinated pyrimidine (8) The values of laboratory findings within 21 days prior to registration meet all the criteria listed below. 1) neutrophil count: >=1,500/mm3 or leucocytes count: >=3,000/mm3 2)platelet count: >=100,000/mm3 3)total-billirubin:<=2.5 times the upper limit of center standard. 4) AST(GOT)and ALT(GPT): <=2.5 times the upper limit of center standard 5) serum creatinine : within the upper limit of center standard |
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Key exclusion criteria | (1) HER2 positive (IHC:3+ or FISH +)
(2) History of non-breast malignancies within the 5 years prior to study entry (3) Symptomatic brain metastasis (4) Diffuse liver meta, or carcinomatous lymphangitis. (5) In addition, the case that a investigator judged to be inadequate |
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Target sample size | 25 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tokyo Women's Medical University, Medical Center East | ||||||
Division name | Department of Breast Surgery | ||||||
Zip code | |||||||
Address | Nishiogu 2-1-10, Arakawa-ku, Tokyo, Japan | ||||||
TEL | 03-3810-1111 | ||||||
shimitsu@dnh.twmu.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Tokyo Women's Medical University, Medical Center East | ||||||
Division name | Department of Breast Surgery | ||||||
Zip code | |||||||
Address | Nishiogu 2-1-10, Arakawa-ku, Tokyo, Japan | ||||||
TEL | 03-3810-1111 | ||||||
Homepage URL | |||||||
ahirasu@dnh.twmu.ac.jp |
Sponsor | |
Institute | Tokyo Women's Medical University |
Institute | |
Department |
Funding Source | |
Organization | Tokyo Women's Medical University |
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 | |
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 | 東京女子医科大学東医療センター(東京都) |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015964 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |