Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments polymorphism analysis, laboratory biomarker analysis, quality-of-life assessment
Sponsor International Breast Cancer Study Group
Start date October 2010
End date December 2020
Trial size 100 participants
Trial identifier NCT01281137, 2007-001370-88, BIG-1-07-SUBSTUDY, CDR0000692740, EU-21101, IBCSG-35-07-SUBSTUDY

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title SOLE Estrogen Substudy (SOLE-EST) - Investigating Changes in Estrogen Levels and Grip Strength for Patients Participating in the SOLE Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by International Breast Cancer Study Group.