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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
Secondary ID [2] 0 0
Universal Trial Number (UTN)
Trial acronym
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

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

Other interventions: 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
Other interventions
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population - In SOLE-EST, levels of E1, E2, and E1S were summarized over time at 0 (baseline), 9, 10.5, and 12 months from randomization among patients in the longitudinal analysis population (N=90 with post-baseline sample).
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 - Changes in hormone levels (E1, E2, and E1S levels), as percentage change over time according to treatment assignment (at 9, 10.5 and 12 months from baseline).
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 - Toxicity grade changes from 6 to 12 months (hot flashes, insomnia and arthralgia; Common Terminology Criteria for Adverse Events (CTCAE) version 3 values 1- 4 grouped as no change, increase in grade [worsening] or decrease in grade [improvement])
Timepoint [1] 0 0
6 and 12 months
Secondary outcome [2] 0 0
Quality of Life (QoL) Score Changes - All patients in SOLE-EST were assessed for symptom specific QoL. QoL changes from 6 to 12 months (sleep change, hot flushes, tiredness, difficulties of becoming aroused, loss of sexual interest, physical wellbeing and mood; LASA (linear analogue self-assessment) scores 0-100 (higher is better QoL) were calculated as 12 months minus 6 months, so that negative is worsening and positive is improvement.
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 - Grip strength was measured using the Martin Vigorimeter (a modified sphygmomanometer which measures the force of compression in kilo pascal by means of a compressible rubber ball). To perform the hand grip test, the patients were asked to squeeze the ball of a modified sphygmomanometer three times with maximal force and the maximal value of three trials of each hand were used for evaluation. Higher value represents greater strength, thus changes are calculated as 12 months minus 9 months so that positive is improved condition and negative is declined condition.
Timepoint [3] 0 0
Changes in grip strength score is calculated at 12 months minus 9 months

Key inclusion criteria

- 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


- Postmenopausal


- See Disease Characteristics
Minimum age
18 Years
Maximum age
120 Years
Can healthy volunteers participate?
Key exclusion criteria

Study design
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
State/province [1] 0 0

Funding & Sponsors
Primary sponsor type
International Breast Cancer Study Group

Ethics approval
Ethics application status

Brief summary
RATIONALE: Studying samples of blood in the laboratory from patients receiving treatment for
cancer may help doctors learn more about changes that may occur in DNA and identify
biomarkers related to cancer.

PURPOSE: This clinical trial is studying 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.
Trial website
Trial related presentations / publications
Public notes

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

Summary results
Other publications