N/A N=104

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

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01281137 ↗

Enrolled (actual)

104

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcome: Primary: Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population — 12.4; 14.3; 4.8; 5.1 pg/mL

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: polymorphism analysis (Genetic); laboratory biomarker analysis (Other); quality-of-life assessment (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: ETOP IBCSG Partners Foundation
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population	12.4; 14.3; 4.8; 5.1; 4.7; 21.6	—
PRIMARY Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group	-58.2; -59.3; -67.3; 76.6; -57.8; 68.7	—
SECONDARY Toxicity Grade Changes for Arthralgia, Hot Flushes, and Insomnia	0.0; 0.0; 0.0; 0.0; 0.0; 0.0	—
SECONDARY Quality of Life (QoL) Score Changes	0.0; -9.5; 2.0; -2.0; -1.0; -9.0	—
SECONDARY Change in Grip-strength Score in the Dominant Hand	-1.0; 0.0	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01281137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.