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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 | UMIN000004458 |
Receipt No. | R000005337 |
Scientific Title | Phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years of prior adjuvant endocrine therapy for postmenopausal women with hormone-receptor positive, node positive early stage breast cancer |
Date of disclosure of the study information | 2010/11/01 |
Last modified on | 2020/05/14 |
Basic information | ||||||||
Public title | Phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years of prior adjuvant endocrine therapy for postmenopausal women with hormone-receptor positive, node positive early stage breast cancer | |||||||
Acronym | JBCRG(SOLE study) | |||||||
Scientific Title | Phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years of prior adjuvant endocrine therapy for postmenopausal women with hormone-receptor positive, node positive early stage breast cancer | |||||||
Scientific Title:Acronym | JBCRG(SOLE study) | |||||||
Region |
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Condition | ||
Condition | Postmenopausal patients with breast cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To compare continuous letrozole for five years with intermittent letrozole over a five year period for postmenopausal women who are disease-free following 4-6 years of prior adjuvant endocrine therapy with SERM(s) and/or AI(s) for endocrine-responsive, node-positive, operable breast cancer.
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Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Explanatory |
Developmental phase | Phase III |
Assessment | |
Primary outcomes | Disease-free survival (DFS): time from randomization to local (including invasive recurrence restricted to the breast after breast conserving treatment), regional or distant relapse, contralateral breast cancer, appearance of a second (non-breast) malignancy, or death from any cause, whichever occurs first. |
Key secondary outcomes | Overall survival (OS), distant disease-free survival (DDFS), breast cancer free interval (BCFI), sites of first failure, second (non-breast) malignancies, deaths without prior cancer events, and adverse events. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | YES |
Institution consideration | |
Blocking | |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | A: Continuous letrozole 2.5 mg daily for 5 years | |
Interventions/Control_2 | B: Intermittent letrozole 2.5 mg daily for the first 9 months of years 1
through 4, followed by 12 months in year 5 |
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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. Completely resected, non-inflammatory breast cancer
2. ER and/or PgR positive 3. postmenopausal 4. Axillary and/or internal mammary lymph nodes positive 5. Any (neo-)adjuvant treatment 6. 4 to 6 years of SERM or AI treatment Last dose of SERM/AI within 1 year prior to randomization 7. No evidence of recurrence at any time 8. No bilateral breast cancer 9. No bone fracture due to osteoporosis during SERM/AI treatment 10. Pathology material from primary tumor available 11. No previous or concomitant malignancy 12. Signed informed consent |
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Key exclusion criteria | 1. Patients must have clinically adequate hepatic function.
2. Patients who have had a bone fracture due to osteoporosis at any time during the 4-6 years of prior endocrine SERM/AI therapy. 3. Patients who have had any previous or concomitant malignancy EXCEPT adequately treated: basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, contra- or ipsilateral in situ breast carcinoma. 4. Patients who have had any other non-malignant systemic diseases (cardiovascular, renal, lung, etc.) that would prevent prolonged follow-up. 5. Patients with psychiatric, addictive, or any disorder which compromises compliance with protocol requirements. |
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Target sample size | 4800 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | IBCSG/European Institute of Oncology | ||||||
Division name | Division of Medical Onclogy | ||||||
Zip code | 20141 | ||||||
Address | Via Ripamonti 435 20141 Milan,Italy | ||||||
TEL | +39-2-5748-9439 | ||||||
marco.colleoni@ieo.it |
Public contact | |||||||
Name of contact person |
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Organization | Japan Breast Cancer Research Group (JBCRG) | ||||||
Division name | Administrative office | ||||||
Zip code | 103-0016 | ||||||
Address | 9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan | ||||||
TEL | +81-3-6264-8873 | ||||||
Homepage URL | http://www.jbcrg.jp/ | ||||||
office@jbcrg.jp |
Sponsor | |
Institute | International Breast Cancer Study Group |
Institute | |
Department |
Funding Source | |
Organization | International Breast Cancer Study Group IBCSG |
Organization | |
Division | |
Category of Funding Organization | Outside Japan |
Nationality of Funding Organization | Switzerland |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | International Breast Cancer Study Group IBCSG |
Address | Effingerstrasse 40, 3008 Bern, Switzerland |
Tel | +41 31 511 94 00 |
ibcsgcc@ibcsg.org |
Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | NCT00553410 |
Org. issuing International ID_1 | Clinical Trials.gov |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 熊本大学病院(熊本県)、都立駒込病院(東京都)、八尾市立病院(大阪府)、新潟県立がんセンター(新潟県)、大阪医療センター(大阪府)、広島大学病院(広島県)、四国がんセンター(愛媛県)、相原病院(大阪府)、北海道がんセンター(北海道)、筑波大学附属病院(茨城県)、九州がんセンター(福岡県)、相良病院(鹿児島県)、京都大学(京都府)、愛知県がんセンター(愛知県)、自治医科大学附属病院(栃木県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Partially published |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
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Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
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Plan to share IPD | |
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=R000005337 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |