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)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Genetic: polymorphism analysis; Other: laboratory biomarker analysis; Procedure: quality-of-life assessment

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.

• Study Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital
• Belgium
  • Liege, Belgium, B-4000
    • CHU Liege - Domaine Universitaire du Sart Tilman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients randomized to the SOLE trial (IBCSG 35-07) and participate in the Quality of Life substudy.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: ETOP IBCSG Partners Foundation
• Investigators: Study Chair: Jacquie Chirgwin, MD, Box Hill Hospital; Study Chair: Guy Jerusalem, MD, PhD, CHU Liege - Domaine Universitaire du Sart Tilman

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): May 15, 2019
• Study Completion (Actual): May 15, 2019

Study Registration Dates

• First Submitted: January 20, 2011
• First Submitted That Met QC Criteria: January 20, 2011
• First Posted (Estimate): January 21, 2011

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: stage IIIA breast cancer; stage II breast cancer; stage IA breast cancer; stage IB breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CDR0000692740; 2007-001370-88 (EudraCT Number); IBCSG-35-07-SUBSTUDY (Other Identifier: IBCSG); BIG-1-07-SUBSTUDY (Other Identifier: Breast International Group); EU-21101