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)

ETOP IBCSG Partners Foundation

Status: Completed

Conditions: Breast Cancer

Treatments: Other: laboratory biomarker analysis; Procedure: quality-of-life assessment; Genetic: polymorphism analysis

Study type: Observational

Funder types: NETWORK

Identifiers

NCT01281137

BIG-1-07-SUBSTUDY (Other Identifier)

2007-001370-88 (EudraCT Number)

IBCSG-35-07-SUBSTUDY (Other Identifier)

CDR0000692740

EU-21101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: Female

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design