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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2019-05-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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polymorphism analysis

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

Intervention Type GENETIC

laboratory biomarker analysis

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

Intervention Type OTHER

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No