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

Breast Cancer Clinical Trial

— SOLE-EST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01281137
• Other study ID #: CDR0000692740
• Secondary ID: IBCSG-35-07-SUBS
• Status: Completed
• Start date: January 2011
• Est. completion date: May 15, 2019

Study information

• Verified date: September 2021
• Source: International Breast Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Australia	Box Hill Hospital	Box Hill	Victoria
Belgium	CHU Liege - Domaine Universitaire du Sart Tilman	Liege

Sponsors (1)

Lead Sponsor	Collaborator
International Breast Cancer Study Group

Countries where clinical trial is conducted

Australia,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	0 (baseline), 9, 10.5, and 12 months from randomization
Primary	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).	9, 10.5, and 12 months from baseline
Secondary	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])	6 and 12 months
Secondary	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.	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	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.	Changes in grip strength score is calculated at 12 months minus 9 months