UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004458
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

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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

Japan Asia(except Japan) North America
South America Australia Europe
Africa


Condition

Condition

Postmenopausal patients with breast cancer

Classification by specialty

Breast surgery

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.

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

Medicine

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

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


Not applicable

Age-upper limit


Not applicable

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

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.

Target sample size

4800


Research contact person

Name of lead principal investigator

1st name Marco
Middle name
Last name Colleoni

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

Email

marco.colleoni@ieo.it


Public contact

Name of contact person

1st name Jun
Middle name
Last name Fukase

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/

Email

office@jbcrg.jp


Sponsor or person

Institute

International Breast Cancer Study Group

Institute

Department

Personal name



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

Email

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

2010 Year 11 Month 01 Day


Related information

URL releasing protocol

https://clinicaltrials.gov/ProvidedDocs/10/NCT00553410/Prot_000.pdf

Publication of results

Published


Result

URL related to results and publications

http://dx.doi.org/10.1016/S1470-2045(17)30715-5

Number of participants that the trial has enrolled

4884

Results

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.

Results date posted

2021 Year 08 Month 24 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2017 Year 11 Month 17 Day

Baseline Characteristics

- 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

Participant flow

- 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

Adverse events

Please refer NCT00553410

Outcome measures

Primary: Disease-free Survival (DFS)
Secondary: Overall Survival, Distant Recurrence-free Interval (DRFI), Breast Cancer-free Interval

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2007 Year 08 Month 01 Day

Date of IRB

2007 Year 08 Month 01 Day

Anticipated trial start date

2007 Year 08 Month 01 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry

2019 Year 02 Month 28 Day

Date trial data considered complete

2019 Year 03 Month 01 Day

Date analysis concluded

2019 Year 05 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 10 Month 27 Day

Last modified on

2021 Year 11 Month 11 Day



Link to view the page

Value
https://center6.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