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)
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|ClinicalTrials.gov Identifier: NCT01281137|
Recruitment Status : Active, not recruiting
First Posted : January 21, 2011
Last Update Posted : August 9, 2017
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Genetic: polymorphism analysis Other: laboratory biomarker analysis Procedure: quality-of-life assessment|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||104 participants|
|Official Title:||SOLE Estrogen Substudy (SOLE-EST) - Investigating Changes in Estrogen Levels and Grip Strength for Patients Participating in the SOLE Trial|
|Actual Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Genetic: polymorphism analysis
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Changes in grip-strength score at 9 months and 12 months [ Time Frame: 12 months after randomization of last patient ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|