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NCT Number: 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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–120 year

Sex eligibility

Female

Study type

Observational

Primary location

Box Hill Hospital, Box Hill, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

polymorphism analysis

Genetic

SNPs will be genotyped in whole blood samples taken at baseline.

laboratory biomarker analysis

Other

Biomarkers will be assessed in blood and serum samples at different time points.

quality-of-life assessment

Procedure

Quality of life will be assessed using the Breast Cancer Prevention Trial (BCPT) Symptom Scales and the IBCSG Trial 35-07 QL Form.

Primary outcomes

  1. Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population

    Time frame: 0 (baseline), 9, 10.5, and 12 months from randomization

    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).

  2. Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group

    Time frame: 9, 10.5, and 12 months from baseline

    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).

Secondary outcomes

  1. Toxicity Grade Changes for Arthralgia, Hot Flushes, and Insomnia

    Time frame: 6 and 12 months

    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])

  2. Quality of Life (QoL) Score Changes

    Time frame: 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

    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.

  3. Change in Grip-strength Score in the Dominant Hand

    Time frame: Changes in grip strength score is calculated at 12 months minus 9 months

    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.

Sponsors and collaborators

Lead sponsor

ETOP IBCSG Partners Foundation

Network

Registry information

Official study title

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

Acronym: SOLE-EST

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Jan 21, 2011
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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