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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00369850




Registration number
NCT00369850
Ethics application status
Date submitted
24/08/2006
Date registered
29/08/2006
Date last updated
27/07/2012

Titles & IDs
Public title
Bone Density and Bone Loss in Postmenopausal Women With Breast Cancer Receiving Treatment in Clinical Trial IBCSG-1-98
Scientific title
Investigating Bone Density and Bone Loss Without Baseline Information
Secondary ID [1] 0 0
IBCSG-18-98-BS
Secondary ID [2] 0 0
CDR0000482381
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Osteoporosis 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Musculoskeletal 0 0 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - laboratory biomarker analysis
Treatment: Surgery - Dual energy X-ray absorptiometry (DEXA)
Treatment: Surgery - Spine X-ray

Experimental: Tamoxifen for 5 years - Patients treated with tamoxifen for 5 years after randomisation.

Experimental: Letrozole for 5 years - Patients treated with letrozole for 5 years after randomisation.

Experimental: Tamoxifen 2 years plus letrozole 3 years - Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.

Experimental: Letrozole 2 years plus tamoxifen 3 years - Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.


Other interventions: laboratory biomarker analysis
Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.

Treatment: Surgery: Dual energy X-ray absorptiometry (DEXA)
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.

Treatment: Surgery: Spine X-ray
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Relative percent change of bone mineral density (BMD) form baseline to after 2, 3, 4, or 5 years of treatment on protocol IBCSG-1-98
Timepoint [1] 0 0
5 years after randomisation to BIG 1-98
Primary outcome [2] 0 0
Recovery of BMD at 1 year after the completion of treatment on protocol IBCSG-1-98
Timepoint [2] 0 0
6 years after randomisation to BIG 1-98
Primary outcome [3] 0 0
Proportion of patients with BMD below the absolute threshold value for osteoporosis
Timepoint [3] 0 0
5 years after randomisation to BIG 1-98
Primary outcome [4] 0 0
Relative percent change in markers of bone resorption from baseline to after 2, 3, 4, or 5 years of treatment on protocol IBCSG-1-98
Timepoint [4] 0 0
5 years after randomisation to BIG 1-98
Primary outcome [5] 0 0
Recovery of the markers of bone resorption at 1 year after the completion of treatment on protocol IBCSG-1-98
Timepoint [5] 0 0
6 years after randomisation to BIG 1-98

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer

* Resected disease
* Enrolled on protocol IBCSG-1-98

* Receiving adjuvant endocrine therapy comprising 1 of the following regimens:

* Letrozole
* Tamoxifen
* Letrozole after 2 years of tamoxifen
* Tamoxifen after 2 years of letrozole
* Not yet completed 5 years of treatment
* No breast cancer recurrence or second primary cancer
* No known, symptomatic bone disease, including osteomalacia or osteogenesis imperfecta
* No prior registration to protocol IBCSG-1-98 Bone Mineral Density substudy
* Hormone receptor status:

* Estrogen receptor-positive and/or progesterone receptor-positive tumor

PATIENT CHARACTERISTICS:

* Female
* Postmenopausal
* No uncontrolled thyroid or parathyroid disease, Cushing's disease, or other pituitary diseases
* No malabsorption syndrome or clinically relevant vitamin D deficiency
* No patients for whom the bone density determination is impossible

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* More than 1 year since prior and no concurrent anticonvulsants
* More than 6 weeks since prior and no concurrent corticosteroids (at doses > the equivalent of 5 mg/day prednisone) for > 2 weeks total
* No prior or concurrent sodium fluoride (at daily doses = 5 mg/day) for > 1 month
* More than 12 months since prior and no concurrent anabolic steroids
* More than 6 months since prior treatment, either investigational or not, for the prevention of osteoporosis (excluding calcium or cholecalciferol [vitamin D])
* No concurrent raloxifene
* Concurrent therapeutic intervention for osteoporosis comprising bisphosphonates allowed
* Concurrent warfarin allowed provided it is given for = 4 weeks
Minimum age
30 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
Accrual to date
Final
458
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Institute of Oncology at Prince of Wales Hospital - Randwick
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Bordeaux
Country [2] 0 0
Italy
State/province [2] 0 0
Aviano
Country [3] 0 0
Italy
State/province [3] 0 0
Bergamo
Country [4] 0 0
Italy
State/province [4] 0 0
Milano
Country [5] 0 0
New Zealand
State/province [5] 0 0
Dunedin
Country [6] 0 0
Peru
State/province [6] 0 0
Lima
Country [7] 0 0
South Africa
State/province [7] 0 0
Cape Town
Country [8] 0 0
Spain
State/province [8] 0 0
Madrid
Country [9] 0 0
Switzerland
State/province [9] 0 0
Aarau
Country [10] 0 0
Switzerland
State/province [10] 0 0
Bern
Country [11] 0 0
Switzerland
State/province [11] 0 0
Lausanne
Country [12] 0 0
Switzerland
State/province [12] 0 0
Mendrisio
Country [13] 0 0
Switzerland
State/province [13] 0 0
St. Gallen
Country [14] 0 0
Switzerland
State/province [14] 0 0
Thun

Funding & Sponsors
Primary sponsor type
Other
Name
ETOP IBCSG Partners Foundation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Diagnostic procedures, such as bone mineral density testing and x-ray, help measure bone loss in women receiving treatment for breast cancer. The test results may help doctors plan better treatment.

PURPOSE: This phase III trial is studying bone density and bone loss in postmenopausal women with breast cancer receiving treatment in clinical trial IBCSG-1-98.
Trial website
https://clinicaltrials.gov/study/NCT00369850
Trial related presentations / publications
Decensi A, Sun Z, Guerrieri-Gonzaga A, Thurlimann B, McIntosh C, Tondini C, Monnier A, Campone M, Debled M, Schonenberger A, Zaman K, Johansson H, Price KN, Gelber RD, Goldhirsch A, Coates AS, Aebi S. Bone mineral density and circulating biomarkers in the BIG 1-98 trial comparing adjuvant letrozole, tamoxifen and their sequences. Breast Cancer Res Treat. 2014 Apr;144(2):321-9. doi: 10.1007/s10549-014-2849-2. Epub 2014 Feb 1.
Public notes

Contacts
Principal investigator
Name 0 0
Stefan Aebi, MD
Address 0 0
Insel Gruppe AG, University Hospital Bern
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00369850