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 (SOLE-EST)
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.
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Procedure: quality-of-life assessment
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||SOLE Estrogen Substudy (SOLE-EST) - Investigating Changes in Estrogen Levels and Grip Strength for Patients Participating in the SOLE Trial|
- Levels of Estradiol (E2), Estrone (E1), and Estrone Sulphate (E1S) at 0, 9, 10.5, and 12 months from randomization on clinical trial IBCSG-35-07 [ Time Frame: 12 months after randomization of last patient ] [ Designated as safety issue: No ]
- Percent change (suppression or recovery) of E2, E1, and E1S at baseline and at 9, 10.5, and 12 months from randomization on clinical trial IBCSG-35-07 [ Time Frame: 12 months after randomization of last patient ] [ Designated as safety issue: No ]
- Toxicity grade changes (for arthralgia, hot flushes, and insomnia) between 6 months (on letrozole) and 12 months (off letrozole for 3 months) and its correlation with the percent of recovery of estrogen levels [ Time Frame: 12 months after randomization of last patient ] [ Designated as safety issue: Yes ]
- Quality of life score change between 6 months (on letrozole) and 12 months (off letrozole for 3 months) and its correlation with the percent of recovery of estrogen levels [ Time Frame: 12 months after randomization of last patient ] [ Designated as safety issue: No ]
- Changes in grip-strength score at 9 months and 12 months [ Time Frame: 12 months after randomization of last patient ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Serum, whole blood,
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||December 2020 (Final data collection date for primary outcome measure)|
Genetic: polymorphism analysis
- To determine the serum level of estrogens (Estradiol [E2], Estrone [E1], and Estrone Sulphate [E1S] and sex hormone binding globulin [SHBG]) in postmenopausal women with prior endocrine-responsive, node-positive, resectable breast cancer completing 4 to 6 years of adjuvant endocrine therapy and enrolled on clinical trial IBCSG-35-07 receiving letrozole.
- To determine the degree of recovery of E2, E1, and E1S during the 3-month letrozole-off gap.
- To determine the association between estrogen level changes and the clinical outcomes of toxicity and quality of life.
- To determine the effect of prior adjuvant endocrine therapy, age, body mass index, and type of menopause on estrogen levels.
- To determine the variability of estrogen level changes and its association with germline single nucleotide polymorphisms.
- To examine changes in grip-strength score.
OUTLINE: This is a multicenter study.
All patients undergo blood sample collection at baseline for the analysis of single nucleotide polymorphisms, after randomization on clinical trial IBCSG-35-07 and prior to the beginning treatment on IBCSG-35-07. Patients also undergo serum collection at baseline and at 9, 10.5, and 12 months for the analysis of estrogen levels and sex hormone binding globulins. Patients undergo measurement of grip strength at baseline and at 9 and 12 months. Samples may be banked for future research studies.
Patients complete quality-of-life questionnaires (Breast Cancer Prevention Trial [BCPT] Symptom Scales on Form 35-PRS and IBCSG Trial 35-07 QL Form) periodically.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281137
|Box Hill Hospital|
|Box Hill, Victoria, Australia, 3128|
|CHU Liege - Domaine Universitaire du Sart Tilman|
|Liege, Belgium, B-4000|
|Study Chair:||Jacquie Chirgwin, MD||Box Hill Hospital|
|Study Chair:||Guy Jerusalem, MD, PhD||CHU Liege - Domaine Universitaire du Sart Tilman|