Clinical trial 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
Official title: SOLE Estrogen Substudy (SOLE-EST) - Investigating Changes in Estrogen Levels and Grip Strength for Patients Participating in the SOLE Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
Lead sponsor: ETOP IBCSG Partners Foundation
Sponsor class: NETWORK
First posted: 2011-01-21
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients randomized to the SOLE trial (IBCSG 35-07) and participate in the Quality of Life substudy.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population
timeFrame: 0 (baseline), 9, 10.5, and 12 months from randomization
measure: Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group
timeFrame: 9, 10.5, and 12 months from baseline
Secondary outcomes:
measure: Toxicity Grade Changes for Arthralgia, Hot Flushes, and Insomnia
timeFrame: 6 and 12 months
measure: Quality of Life (QoL) Score Changes
timeFrame: 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
measure: Change in Grip-strength Score in the Dominant Hand
timeFrame: Changes in grip strength score is calculated at 12 months minus 9 months
Other outcomes:
Locations:
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Liege
country: Belgium
facility: CHU Liege - Domaine Universitaire du Sart Tilman
Study officials:
affiliation: Box Hill Hospital
name: Jacquie Chirgwin, MD
role: STUDY_CHAIR
affiliation: CHU Liege - Domaine Universitaire du Sart Tilman
name: Guy Jerusalem, MD, PhD
role: STUDY_CHAIR
References: