NCT01281137

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 Estrogen Substudy (SOLE-EST) - Investigating Changes in Estrogen Levels and Grip Strength for Patients Participating in the SOLE Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 104 (actual)
• Sponsor: ETOP IBCSG Partners Foundation · Network
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
GENETIC	polymorphism analysis	SNPs will be genotyped in whole blood samples taken at baseline.
OTHER	laboratory biomarker analysis	Biomarkers will be assessed in blood and serum samples at different time points.
PROCEDURE	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.

Timeline

• Start date: 2011-01-01
• Primary completion: 2019-05-15
• Completion: 2019-05-15
• First posted: 2011-01-21
• Last updated: 2021-10-06
• Results posted: 2021-10-06

Locations

2 sites across 2 countries: Australia, Belgium