Unique ID issued by UMIN | UMIN000004458 |
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Receipt number | 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 | 2021/11/11 17:17:06 |
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
JBCRG(SOLE study)
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
JBCRG(SOLE study)
Japan | Asia(except Japan) | North America |
South America | Australia | Europe |
Africa |
Postmenopausal patients with breast cancer
Breast surgery |
Malignancy
NO
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.
Safety,Efficacy
Confirmatory
Explanatory
Phase III
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.
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.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Central registration
2
Treatment
Medicine |
A: Continuous letrozole 2.5 mg daily for 5 years
B: Intermittent letrozole 2.5 mg daily for the first 9 months of years 1
through 4, followed by 12 months in year 5
Not applicable |
Not applicable |
Female
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
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.
4800
1st name | Marco |
Middle name | |
Last name | Colleoni |
IBCSG/European Institute of Oncology
Division of Medical Onclogy
20141
Via Ripamonti 435 20141 Milan,Italy
+39-2-5748-9439
marco.colleoni@ieo.it
1st name | Jun |
Middle name | |
Last name | Fukase |
Japan Breast Cancer Research Group (JBCRG)
Administrative office
103-0016
9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
+81-3-6264-8873
http://www.jbcrg.jp/
office@jbcrg.jp
International Breast Cancer Study Group
International Breast Cancer Study Group IBCSG
Outside Japan
Switzerland
International Breast Cancer Study Group IBCSG
Effingerstrasse 40, 3008 Bern, Switzerland
+41 31 511 94 00
ibcsgcc@ibcsg.org
YES
NCT00553410
Clinical Trials.gov
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)
2010 | Year | 11 | Month | 01 | Day |
https://clinicaltrials.gov/ProvidedDocs/10/NCT00553410/Prot_000.pdf
Published
http://dx.doi.org/10.1016/S1470-2045(17)30715-5
4884
From the current analysis, we conclude that extended treatment with intermittent letrozole did not improve disease-free survival versus treatment with continuous letrozole. The safety, quality-of-life, and efficacy results of the intermittent administration provide clinically relevant information about extended adjuvant endocrine therapy with letrozole and support the safety of this option for temporary treatment breaks in selected patients who might require them.
2021 | Year | 08 | Month | 24 | Day |
2017 | Year | 11 | Month | 17 | Day |
- Female
- Must be postmenopausal by any of the following criteria:
-Patients of any age who have had a bilateral oophorectomy (including radiation castration AND amenorrheic for > 3 months)
- Patients 56 years old or older with any evidence of ovarian function must have biochemical evidence of definite postmenopausal status (defined as estradiol, luteinizing hormone [LH], and follicle-stimulating hormone [FSH] in the postmenopausal range)
- Patients 55 years old or younger must have biochemical evidence of definite postmenopausal status (defined as estradiol, LH, and FSH in the postmenopausal range)
- Patients who have received prior luteinizing-hormone releasing-hormone (LHRH) analogues within the last year are eligible if they have definite evidence of postmenopausal status as defined above
- Clinically adequate hepatic function
- No bone fracture due to osteoporosis at any time during the 4-6 years of prior therapy
- No prior or current malignancy except adequately treated basal cell or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, or contra- or ipsilateral in situ breast carcinoma
- No other nonmalignant systemic diseases (cardiovascular, renal, lung, etc.) that would prevent prolonged follow-up
- No psychiatric, addictive, or any other disorder that compromises compliance with protocol requirements
- See Disease Characteristics
- More than 12 months since prior and no other concurrent endocrine SERM/AI therapy
- Any type of prior adjuvant therapy allowed including, but not limited to, any of the following:
-Neoadjuvant chemotherapy
-Neoadjuvant endocrine therapy
-Adjuvant chemotherapy
-Trastuzumab (Herceptin)
-Ovarian ablation
-Gonadotropin releasing hormone analogues
-Lapatinib ditosylate
-No concurrent hormone-replacement therapy, bisphosphonates (except for treatment of bone loss), or any other investigational agent
Please refer NCT00553410
Primary: Disease-free Survival (DFS)
Secondary: Overall Survival, Distant Recurrence-free Interval (DRFI), Breast Cancer-free Interval
Completed
2007 | Year | 08 | Month | 01 | Day |
2007 | Year | 08 | Month | 01 | Day |
2007 | Year | 08 | Month | 01 | Day |
2018 | Year | 12 | Month | 31 | Day |
2019 | Year | 02 | Month | 28 | Day |
2019 | Year | 03 | Month | 01 | Day |
2019 | Year | 05 | Month | 01 | Day |
2010 | Year | 10 | Month | 27 | Day |
2021 | Year | 11 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005337
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