Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01281137




Registration number
NCT01281137
Ethics application status
Date submitted
20/01/2011
Date registered
21/01/2011
Date last updated
6/10/2021

Titles & IDs
Public title
Study of Changes in Estrogen Levels and Grip Strength in Postmenopausal Women Who Have Received 4 to 6 Years of Hormone Therapy for Breast Cancer and Are Currently Receiving Letrozole on Clinical Trial IBCSG-35-07
Scientific title
SOLE Estrogen Substudy (SOLE-EST) - Investigating Changes in Estrogen Levels and Grip Strength for Patients Participating in the SOLE Trial
Secondary ID [1] 0 0
IBCSG-35-07-SUBSTUDY
Secondary ID [2] 0 0
CDR0000692740
Universal Trial Number (UTN)
Trial acronym
SOLE-EST
Linked study record

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

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Other - polymorphism analysis
Other interventions - laboratory biomarker analysis
Treatment: Surgery - quality-of-life assessment

Treatment: Other: polymorphism analysis
SNPs will be genotyped in whole blood samples taken at baseline.

Other interventions: laboratory biomarker analysis
Biomarkers will be assessed in blood and serum samples at different time points.

Treatment: Surgery: quality-of-life assessment
Quality of life will be assessed using the Breast Cancer Prevention Trial (BCPT) Symptom Scales and the IBCSG Trial 35-07 QL Form.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Intervention code [3] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population
Timepoint [1] 0 0
0 (baseline), 9, 10.5, and 12 months from randomization
Primary outcome [2] 0 0
Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group
Timepoint [2] 0 0
9, 10.5, and 12 months from baseline
Secondary outcome [1] 0 0
Toxicity Grade Changes for Arthralgia, Hot Flushes, and Insomnia
Timepoint [1] 0 0
6 and 12 months
Secondary outcome [2] 0 0
Quality of Life (QoL) Score Changes
Timepoint [2] 0 0
6 and 12 months: Change is calculated from 12 months minus 6 months, therefore positive values indicate an improved condition and negative values indicate a declined condition
Secondary outcome [3] 0 0
Change in Grip-strength Score in the Dominant Hand
Timepoint [3] 0 0
Changes in grip strength score is calculated at 12 months minus 9 months

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Previously diagnosed with breast cancer

* Endocrine-responsive, node-positive, resectable disease
* Disease-free following 4-6 years of prior adjuvant endocrine therapy with selective estrogen-receptor modulators and/or aromatase inhibitors
* Patient must be currently enrolled on clinical trial IBCSG-35-07 as well as the Quality-of-Life substudy
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Postmenopausal

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Minimum age
18 Years
Maximum age
120 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/05/2019
Sample size
Target
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Liege

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jacquie Chirgwin, MD
Address 0 0
Box Hill Hospital
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01281137