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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 | UMIN000001552 |
Receipt No. | R000001875 |
Scientific Title | Health-related quality of life of postmenopausal women treated with Letrozole as adjuvant therapy for hormone receptor-positive early breast cancer (SBCCSG-15) |
Date of disclosure of the study information | 2008/12/05 |
Last modified on | 2017/11/30 |
Basic information | ||
Public title | Health-related quality of life of postmenopausal women treated with Letrozole as adjuvant therapy for hormone receptor-positive early breast cancer (SBCCSG-15) | |
Acronym | Health-related quality of life of postmenopausal women treated with Letrozole as adjuvant therapy for hormone receptor-positive early breast cancer (SBCCSG-15) | |
Scientific Title | Health-related quality of life of postmenopausal women treated with Letrozole as adjuvant therapy for hormone receptor-positive early breast cancer (SBCCSG-15) | |
Scientific Title:Acronym | Health-related quality of life of postmenopausal women treated with Letrozole as adjuvant therapy for hormone receptor-positive early breast cancer (SBCCSG-15) | |
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Condition | |||
Condition | postmenopausal breast cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Evaluate health related quality of life during treated with Letrozole as adjuvant therapy for hormone receptor-positive early breast cancer and analyze by the difference of baseline characteristics ( e.g age, comorbidity, treatment ). Assess arthralgia, one of the most common adverse events, in detail. |
Basic objectives2 | Others |
Basic objectives -Others | HRQOL |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Change rate of FACT-ES score |
Key secondary outcomes | Change rate of FACT-G score
Arthralgia related with AI FACT-ES score by baseline characters before and after treatment Difference of the evaluation of arthralgia between investigators and patients-self |
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 | Letrozole 2.5mg daily p.o. as adjuvant therapy | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | 1. histologically diagnosed with unilateral primary breast cancer, stage 0-IIIC. ( previous local radiotherapy and/or systemic chemotherapy are allowed )
2. ER and/or PgR positive 3. PS(ECOG)0,1 4. postmenopausal patients who satisfies one or more below criteria; A. age 60 or more B. Prior bilateral oophorectomy C. amenorrheic for 1 year or more D. FSH and plasma estradiol level in postmenopausal ranges 5. adequate major organ function 6. informed consent has been obtained in writing |
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Key exclusion criteria | 1. patients have been treated with medicine which may have some effect for sex hormone or trastuzumab
2. patients being treated with chemotherapy 3. Serious complications ( e.g malignant hypertension, CHF, hepatic failure, MI within 6 months, PE, arrhythmia treatment needed, infection, hemorrhagic tendency ) 4. active multiple cancer |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Saitama Cancer Center | ||||||
Division name | Breast Oncology | ||||||
Zip code | |||||||
Address | 818 Komuro Ina Kitaadachi, Saitama 362-0806 | ||||||
TEL | 048-722-1111 | ||||||
toshikai@sbccsg.org |
Public contact | |||||||
Name of contact person |
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Organization | NPO Saitama Breast Cancer Clinical Study Group (SBCCSG) | ||||||
Division name | Executive office(c/o: Shin-toshin Ladies MammoClinic) | ||||||
Zip code | |||||||
Address | 3F, Capital Bldg. 4-261-1, Kishiki-cho, Omiya-ku, Saitama-City 330-0843, Saitama Prefecture | ||||||
TEL | 048-600-1722 | ||||||
Homepage URL | http://www.sbccsg.org/ | ||||||
toshikai@sbccsg.org |
Sponsor | |
Institute | NPO Saitama Breast Cancer Clinical Study Group (SBCCSG) |
Institute | |
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Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
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Other | |
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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=R000001875 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |